18-BI-1206-03: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody CD32b (FcƴRIIB) in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: BioInvent International AB
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to see if a medicine not yet approved by the FDA, named BI-1206, will help in the treatment of advanced solid tumors and also how safe it is for people to use in combination with pembrolizumab, which is an approved drug under the trade name of Keytruda.
There are 2 parts to this study: Part 1 (dose escalation) Part 2 (dose expansion). When enrollment is completed to Part 1 then Part 2 (dose expansion) will open.
Inclusion Criteria:
– At least 18 years of age on day of signing informed consent.
– Has a histologically confirmed advanced solid tumor.
– Must have received at least 2 doses of an approved anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb.
– Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
– Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206 (on non-previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor-directed therapy.
– Has an ECOG performance status of 0-1.
– Has adequate organ function as confirmed by laboratory values.
– Has a life expectancy of at least 12 weeks.
Exclusion Criteria:
– Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
– Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated CNS metastases may participate provided they are radiologically stable.
– Has cardiac or renal amyloid light-chain amyloidosis.
– Has received chemotherapy or small molecule products within 4 weeks of first dose of BI-1206.
– Has received radiotherapy within 2 weeks of first dose of BI-1206.
– Has received immunotherapy within 4 weeks prior to the first dose of BI-1206.
– Has an active, known or suspected autoimmune disease.
– Has had an allogenic tissue/solid organ transplant.
– Has uncontrolled or significant cardiovascular disease.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/Refractory Solid Tumors (PSB205-001)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Qilu Puget Sound Biotherapeutics Corporation
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: This is a study of a drug called PSB205 for the treatment of solid tumors. PSB205 works in two ways and can cause fewer potential side effects than those caused by the combination of Nivolumab and Ipilimumab. PSB205 has been shown to have the same effect on tumors as the combination of Nivolumab and Ipilimumab.
Inclusion Criteria:
-Patients aged 18 years or older.
-ECOG Performance status of less than or equal to 2.
-Life expectancy of greater than or equal to 3 months.
-Adequate bone marrow, organ function and laboratory parameters.
-Female subjects who are not pregnant or breastfeeding.
-Recovered from all reversible AEs due to previous anticancer therapies.
-Suitable venous access for the study required blood sampling.
-Must have one of the following solid tumors: Advanced or metastatic clear cell RCC or non-clear cell RCC, urothelial cancer, small cell lung cancer, advanced soft tissue or bone sarcoma, metastatic melanoma, or mismatch-repair-deficient malignancies.
Exclusion Criteria:
-Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years.
-Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression.
-Hypertension unable to be controlled with medication.
-Any condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before first dose of study drug. Corticosteroids for topical use, nasal spray, and inhaled steroids are allowed. Systemic corticosteroids for prophylaxis of contrast allergy are permitted.
-Prior treatment with a CTLA-4 inhibitor in combination with a PD-1 or PD-L1 inhibitor.
-Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
-Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
-Subjects with a history of organ transplant.
-Hepatitis B surface antigen-positive or known or suspected active hepatitis C infection.
-Known human immunodeficiency virus (HIV) positive.
Study Contact:
Lisa Wahowske, RN
(651) 254-1517
lisa.wahowske@parknicollet.com
ALK4230-001: A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors (ARTISTRY-2)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Alkermes, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to assess the safety and identify the recommended dosing of an experimental drug called ALKS 4230 alone or in combination with a drug that has been approved by the FDA called KEYTRUDA® (pembrolizumab). Eligible patients will be those who have a solid tumor that is resistant to some or all of the available standard treatments, or for which no standard treatment is available.
Inclusion Criteria:
For Part A the subject has histological or cytological evidence of a solid tumor. For Part B the subject must have 1 of the unspecified adult solid tumor types defined in the protocol.
- Record of programmed cell death ligand 1 protein expression status, or availability of fresh or archival tumor tissue for cellular characterization and PD-L1 status.
- Subjects must have adequate liver function.
- Subjects must have adequate kidney function.
- Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery.
- Subjects who have received radiation therapy must wait at least 4 weeks after their last radiation treatment before enrollment into the study.
- Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered.
- Subject will agree to follow contraceptive requirements defined in the protocol
- Additional criteria may apply.
Exclusion Criteria:
- Subject is currently pregnant, planning to become pregnant, or breastfeeding
- Subjects with an active infection or with a fever ≥ 38.5°C within 3 days of the first scheduled day of dosing for Cycle 1
- Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks, and the subject is neurologically stable
- Subjects with known hypersensitivity to any components of ALKS 4230 or to pembrolizumab or any of its excipients
- Subjects who require pharmacologic doses of steroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
- Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and/or neuropathy
- Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subjects to cooperate and participate in the study
- The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis
- Additional criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
DF6002-001: A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination with Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Dragonfly Therapeutics, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The purpose of this study is to test the levels of the investigational medicine, DF6002, in your blood, the safety of DF6002, and how people with solid tumor cancers respond to the investigational medicine both by itself as well as in combination with Keytruda (pembrolizumab).
DF6002 is a type of protein that binds to immune receptors which produce an immune response. It is not approved by the FDA. Keytruda is already approved for the treatment of multiple types of solid tumors, but the Sponsor is interested in understanding how the study drug investigational medicine works when given together with Keytruda.
Inclusion Criteria:
– At least 18 yeas of age.
– Histologically or cytologically proven locally advanced or metastatic solid tumors for which no standard therapy exists, or standard therapy has failed.
– ECOG performance status of 0-1.
– Clinical or radiological evidence of disease.
– Adequate hematological, hepatic, and renal function.
– Other criteria may apply depending on tumor type.
Exclusion Criteria:
– Concurrent treatment with a non-permitted drug.
– Prior treatment with rhIL2 or any recombinant long acting drug containing an IL2 moiety.
– Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment.
– Previous malignant disease other than the target malignancy to be investigated in this study within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ.
– Rapidly progressive disease.
– Active or history of central nervous system (CNS) metastases.
– Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
– Other criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
Destiny 07: A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer (DB-07)
Principal Investigator: Priya Kumar, MD
Study Sponsor: AstraZeneca, Daiichi Sankyo
Location: Regions Cancer Care Center
Phase of Study: Phase 1b/2
Purpose of study: DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer. The study will assign patients to different treatment combinations.
Inclusion Criteria:
- Patients must be at least 18 years of age
- Pathologically documented breast cancer that:
- Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment
- Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
- Patient must have adequate tumor sample for biomarker assessment
- ECOG Performance Status of 0 or 1
- Part 1
- Disease progression on or after the last systemic therapy prior to starting study treatment
- At least 1 prior treatment line in metastatic setting required.
- Part 2 (Modules 0 – 5)
- a) No prior lines of therapy for advanced/MBC allowed
- Part 2 (Module 6 and 7)
- a) Zero or one prior lines of therapy for advanced/MBC allowed
- CNS Inclusion:
- Modules 0 – 5 Patients must have no brain metastases or stable brain metastases.
- Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy
- Has a life expectancy of at least 12 weeks.
- Additional criteria may apply and will be discussed with the physician.
Exclusion Criteria:
- Uncontrolled or significant cardiovascular disease
- Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Lung-specific intercurrent clinically significant illnesses
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Spinal cord compression or a history of leptomeningeal carcinomatosis
- Prior treatment with immune checkpoint inhibitors
- Prior treatment with an ADC containing a topoisomerase I inhibitor
- Prior treatment with tucatinib
- CNS Exclusion:
- Modules 0 – 5: Has untreated brain metastasis
- Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases or brain lesion thought to require immediate local therapy
- Additional criteria may apply and will be discussed with the physician.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
Destiny 08: A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer (DB-08)
Principal Investigator: Priya Kumar, MD
Study Sponsor: AstraZeneca
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The study will initially consist of 5 treatment modules, each of which includes Trastuzumab Deruxtecan in combination with other anti-cancer agents. Each module will have 2 parts: a dose-finding phase (Part 1) and a dose-expansion phase (Part 2). The Part 2 dose-expansion phase will use the recommended Phase 2 dose (RP2D) for the combination, either as determined in Part 1 or from another clinical study if appropriate. For each module, patients will be centrally assigned to one of the open modules, as per the module specific criteria.
Inclusion Criteria:
- Patients must be at least 18 years of age
- Male or female patients who have pathologically documented breast cancer that:
- Has a history of HER2-low expression; defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay
- Is documented as HR+ (either ER and/or PgR positive [ER or PgR ≥1%]) or ER and PgR negative (ER and PgR <1%) per ASCO/CAP guidelines in the metastatic setting
- Patient must have adequate tumor sample for biomarker assessment
- ECOG Performance Status of 0 or 1
- For patients with HR+ disease:
- Part 1: At least 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors), and at least 1 prior line of chemotherapy for MBC are required.
- Part 2: Only 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors) for MBC is allowed. No prior chemotherapy in the metastatic setting is allowed. Note there are no patients with HR+ disease in Part 2 of Modules 2 and 3.
- For patients with HR- disease:
- Part 1: At least 1 prior line of chemotherapy for MBC is required. Note there are no patients with HR- disease in Part 1 of Modules 4 and 5.
- Part 2: For Module 2, no prior lines of therapy for MBC are allowed, and for Modules 1 and 3, only 1 prior line of chemotherapy for MBC is allowed. Note there are no patients with HR- disease in Part 2 of Modules 4 and 5.
- Additional criteria may apply and will be discussed with the Physician.
Exclusion Criteria:
- Uncontrolled intercurrent illness
- Uncontrolled or significant cardiovascular disease
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected
- ILD/pneumonitis cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant illnesses
- Has spinal cord compression or clinically active central nervous system metastases
- Active primary immunodeficiency
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Prior treatment with ADC that comprises of an exatecan derivative that is a topoisomerase I inhibitor
- Additional criteria may apply and will be discussed with the Physician.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
GNX-001: A Phase I Study of GNX102 in patients with Advanced Solid Tumors
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Glyconex, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The purposes of this study are to determine the right dose of GNX102 that can be tolerated by people with cancer, and, to see if it can shrink the tumors. GNX102, is an antibody that binds to a certain target on the surface of the cancer cells. This target has been shown to be present on the surface of many different types of tumors. When this study medication binds to this target it is thought that it may kill the cancer cells.
Eligible patients will be those that have cancer that has continued to grow despite having tried many different treatments.
Inclusion Criteria:
– Must be at least 18 years of age.
– Must have histologially confimred solid tumor with a likelihood of expression of GNX102 targeted antigens (for example: colorectal, hepatocellular, non-small cell lung, gastric, breast, bladder, pancreatic, melanoma, esophageal, prostate, ovarian, cervical, and epithelial uterine cancers).
– Advanced, unresectable (local, regionally, recurrent not amenable to curative therapy) or metastatic disease that has no standard therapeutic option with a proven clinical benefit.
– ECOG performance status of 0-1
– Acceptable liver, renal, and hematologic function (as determined by blood tests).
– Acceptable coagulation status.
– Life expectancy of at least 3 months.
– Other criteria may apply.
Exclusion Criteria:
– Has any other malignancy.
– Has a positive PCR test for active COVID-19 infection or has signs or symptoms consistent with COVID-19 in the absence of a negative PCR test.
– Has New York Heart Association Class III or IV heart disease.
– History of myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, within the past 6 months.
– History of cerebral vascular accident or transient ischemic attack within the past 6 months.
– History of primary CNS tumor.
– History of CNS metastases, unless previously treated and stable for at least 4 weeks in the absence of steroids. Patients with meningeal carcinomatosis are excluded regardless of treatment.
– Active, nonmalignant gastrointestinal (GI) disease requiring treatment (such as inflammatory bowel disease, Crohn’s disease, colitis) that would impart excess risk associated with study participation or study drug administration
– Other criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
HC-404-FCP-2011: A Multicenter, Open-label, Phase 1a Study of HC 5404-FU in Subjects with Selected, Advanced Solid Tumors.
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: HiberCell, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: This is a first-in-human study designed to establish the maximum tolerated dose, and to evaluate the safety and tolerability of oral drug HC-5404-FU in subjects with advanced solid tumors. Specific tumor types evaluated in this study are; renal cell carcinoma, gastric cancer, metastatic breast cancer, or small-cell lung cancer. HC-5404-FU is highly selective for protein kinase RNA-like endoplasmic reticulum kinase (PERK) and acts as a PERK inhibitor. PERK plays an important role in tumor growth and new blood vessel development, therefore interfering with PERK function could potentially lead to tumor growth inhibition.
Inclusion Criteria:
- Have a signed informed consent form (ICF) prior to any study-specific procedures or treatment
- Be ≥18 years of age (male or female) at the time of consent
- Have 1 of the following histologically or cytologically confirmed tumor types with qualifying characteristics, and have received a minimum of 3 (and no more than 5) lines of prior therapy for metastatic (Stage IV) disease:
a. RCC (renal cell carcinoma – clear cell or papillary)
b. GC (gastric adenocarcinoma)
c. Human epidermal growth factor receptor positive (HER2+) MBC
(metastatic breast cancer)
d. SCLC (small cell lung cancer) - Have at least 1 radiologically measurable lesion as per RECIST v1.1.
- Two biopsies will be necessary: at baseline (within 30 days prior to first dose) and within 7 days after Cycle 3/Day 1. Newly obtained biopsy specimens are preferred to archived samples, and formalin-fixed, paraffin-embedded block specimens are preferred to slides. In the event a fresh pre-treatment biopsy is not able to be provided, the most recent archival biopsy must be provided in its place.
- ECOG Status of 0 or 1.
- Have life expectancy of 3 months or greater as determined by the treating physician.
- Have adequate organ function within 15 days prior to first administration of dose.
- Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures.
- Additional criteria may apply and will be discussed in further detail with the physician.
Exclusion Criteria:
- Subject is currently pregnant, planning to become pregnant, or breastfeeding
- Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of study treatment or who has not recovered from adverse reactions due to a previously administered agent or major surgery.
- Is currently participating in a clinical trial and is receiving treatment using an investigational drug or investigational device, or has received treatment using an investigational therapy within 4 weeks prior to first dose.
- Has a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Has known history of active tuberculosis, history of HIV (HIV 1/2 antibodies), has known active Hepatitis B (anti-hepatitis B surface antibody, anti-hepatitis B core antibody, hepatitis B surface antigen [HBsAg]) or Hepatitis C (hepatitis C antibody) infection, history of clinically severe autoimmune disease, or a history of organ transplant.
- Has been diagnosed with severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infection and/or is seropositive for (SARS-CoV)-2 antibodies, as per the local guidelines at screening and is positive by 7 days prior to the first dose of study treatment.
- Has insulin-dependent (Type I) diabetes or poorly controlled Type II diabetes (per clinical discretion).
- Has known additional malignancy that is progressing or required active treatment within previous 5 years. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy, superficial bladder cancer, or in situ cervical cancer. Subjects with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
- Has known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using systemic steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has a history of interstitial lung disease, pneumonitis within 12 months prior to screening or current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or ongoing clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome, symptomatic or uncontrolled arrhythmia, congestive heart failure, baseline ECG abnormalities, including, but not limited to, QTc prolongation (prolonged QTcF defined as ≥450 msec) or any Class III or IV cardiac disease as defined by the New York Heart Association Functional Classification.
- Has overt or latent disorders of the exocrine pancreas (such as acute or chronicpancreatitis of any etiology) or chronic (including autoimmune) gastrointestinal disorders such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, lupus, scleroderma, Sjogren’s syndrome, and polyarteritis nodosa.
- Has a known psychiatric or substance abuse disorder(s) that would interfere with informed consent or cooperation with the requirements of the trial.
- Additional exclusion criteria may apply and will be discussed with physician.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
TAK 981-1002: A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics (PK) of TAK-981 in Adult Participants With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies and in a Subset With Coronavirus Disease 2019 (COVID-19)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Takeda Pharmaceuticals
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of Study: The purpose of this study is to evaluate safety, tolerability and to identify the most appropriate dose of TAK-981 as treatment for patients with cancer. In addition, this study will also serve to obtain information on the amount of study drug in your blood after taking single and/or multiple doses of the study drug.
The main purposes of this study are:
– To determine if TAK-981 is safe in patients with cancer.
– To select the dose for future studies.
– To measure the amount of TAK-981 in your blood.
– To assess the anti-tumor effect of TAK-981.
– To assess how the research drug reaches its target protein (called SUMO activating enzyme). Small Ubiquitin-like
Modifier (or SUMO) proteins are proteins that attach and detach from other proteins. This happens in normal and
tumor cells to modify their function. SUMOylation is the process of adding these SUMO proteins to other proteins.
The process of SUMOylation allows growth of tumor cells, and prevents the immune system from attacking the
tumor. TAK-981 reduces SUMOylation, allowing the immune system to attack the tumor cells.
– To obtain information on how your body reacts to the study drug by looking at biomarkers. Biomarkers are
measurable substances that can be found in different tissues of your body like the blood, skin and the tumor.
– To determine if the amount of TAK-981 in your blood has any impact on your ECG results (heart function test).
TAK-981 is an investigational drug that has not yet been studied in humans. It has not been approved by the FDA (U.S. Food and Drug Administration) or other regulatory authorities for use by the general public. TAK-981 will be investigated in adult patients with metastatic solid tumors or lymphomas for which standard curative treatment or life-prolonging treatment does not exist, is no longer effective or if it cannot be tolerated or is not indicated for you.
Inclusion Criteria:
– Adult male of female patients >/= 18 years old.
– Eastern Cooperative Group (ECOG) performance status of 0 to 1.
– Patients with histologically confirmed advanced (local regionally recurrent not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven clinical benefit, are intolerant or have refused them, OR
– Patients with relapsed/refractory lymphoma not amenable to therapies with proven clinical benefit or who are intolerant or who refuse them. Patients with low-grade lymphomas such as follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, and marginal zone lymphomas may not need to exhaust all available therapy.
– Adequate bone marrow reserve and renal and hepatic function.
Exclusion Criteria:
– Treatment with systemic anticancer treatments or investigational products within 14 days before the first dose of study drug or 5 half-lives, whichever is shorter. Patients should have recovered from previous treatment toxicity to Grade 1, baseline (except alopecia and peripheral neuropathy), or the toxicity is considered established as a sequela.
– History of uncontrolled brain metastasis. Patients with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and the patients is receiving a corticosteroid dose ≤10 mg/day of prednisone equivalent at the time of receiving the first dose of TAK-981. For asymptomatic patients, screening brain imaging is not required.
– Patient has received extended field radiotherapy ≤4 weeks before the start of treatment (≤2 weeks for limited field radiation for palliation), and who has not recovered to grade 1 or better from related side effects of such therapy (except for alopecia).
– Patient is receiving any live vaccine (eg, varicella, pneumococcus) within 4 weeks of initiation of study treatment.
– History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias of >Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
