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 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
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 (PSB205-201)
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
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Turning Point Therapeutics
Location: Regions Cancer Care Center
Phase of Study: Phase 2
Purpose of study: This is an investigational study of a drug named Reprotrectinib that will be given to patients with advanced solid tumors with ALK, ROS1, or NTRK1-3 rearrangements. Repotrectinib will provide opportunities in clinic to stop the abnormal cell signaling of ALK/ROS1/TRKs in solid malignancies, and overcome your body’s natural resistance to treatment of advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements.
Inclusion Criteria:
-18 years of age or older
-Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
-At least 1 measurable lesion according to RECIST (v1.1)
-Prior cytotoxic chemotherapy is allowed. At least 14 days must have elapsed after discontinuation of prior cytotoxic chemotherapy before starting study drug.
-Prior immunotherapy (eg, anti-PD-1, anti-PD-L1, anti-TIM3, and anti-OX40) is allowed
-Subjects with advanced solid tumors harboring ALK, ROS1, NTRK1, NTRK2, or NTRK3 rearrangements are eligible. There is no limit to the number of prior chemotherapy, immunotherapy, or TKI regimens.
Exclusion Criteria:
-Concurrent participation in another therapeutic clinical trial.
-Symptomatic brain metastases or leptomeningeal involvement.
-History of previous cancer requiring therapy within the previous 2 years except for squamous cell or basal-cell carcinoma of the skin.
-Major surgery within 4 weeks of start of Reprotrectinib treatment. Radiation therapy within 2 weeks of study entry.
-Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment).
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
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
Stellar-001 (Innate) – (INAT STELLAR001 P1 AST)
Principal Investigator: Dylan Zylla, MD
Study Sponsor: Innate Pharma SA
Location: Frauenshuh Cancer Center
Phase of Study: Phase I
Purpose of study: STELLAR-001: A phase I study of the anti-C5aR, IPH5401, in combination with the anti-PD-L1, durvalumab, in patients
with selected advanced solid tumors
Inclusion Criteria:
Patients must meet all of the inclusion criteria in order to be eligible to participate in the study.
1) Dose escalation: Patients with advanced and/or metastatic histologically confirmed HCC, UCC, RCC or NSCLC solid tumors with evidence of active disease, who have been treated with a minimum of one line of systemic therapy in the metastatic setting. Patients should have received known standard therapies (including platinum-based chemotherapy in patients with UCC), unless not available or contraindicated.
2) Cohort expansion
i. NSCLC:
a. Histologically confirmed unresectable advanced and/or metastatic NSCLC
b. Patients should have been treated with no more than two lines of systemic therapies in the advanced/metastatic setting that include platinum based chemotherapy.
c. Patients should have received anti-PD1/anti-PD-L1 either as:
i. Single agent: In this case, patients should have had either RECIST response or stable disease for a minimum of 6 months before disease progression.
ii. In combination with first line platinum-based chemotherapy: In this case, patients should have had a RECIST response for a minimum of 6 months before disease progression.
ii. HCC:
a. Histologically confirmed unresectable advanced and/or metastatic HCC.
b. Child-Pugh Score Class A.
c. Patients should have been previously treated with no more than 2 lines of systemic therapy in the advanced/metastatic setting that should include sorafenib.
d. Patients should be naïve to treatment with anti-PD1/anti-PD-L1 therapy.
3) At least 18 years of age.
4) ECOG performance status of ≤1.
5) Adequate organ function defined as:
a. Hematological
i. Absolute neutrophilic count ≥ 1.5 x 109/L
a. For HCC ≥ 1.0 x 109/L
ii. Hemoglobin ≥ 9.0 g/dL
iii. Platelet count ≥ 75 x 109/L
b. Hepatic
i. Total bilirubin ≤ 1.5 x ULN
a. For HCC ≤ 2 x ULN
ii. AST and ALT ≤ 3 x ULN (and up to 5 x ULN in the presence of liver metastases)
iii. Albumin ≥ 3.3 g/dL (except for patients with HCC: albumin ≥ 2.8 g/dL)
iv. For HCC: INR < 1.7
c. Renal: calculated creatinine clearance (Cockcroft-Gault formula ≥ 50 mL/min
6) At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline.
7) Feasibility of obtaining tumor biopsy for patients included in the cohort expansion.
8) All AEs while receiving prior treatment with immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
9) No active viral hepatitis B or C.
a. Active hepatitis B is defined by HBV DNA and/or HBsAg positivity.
b. Active hepatitis C is defined by HCV RNA positivity.
10) Women of childbearing potential must have a negative serum or urine beta-HCG pregnancy test result within seven days of treatment and must practice an effective method of contraception during treatment and for at least 6 months (180 days) following the last dose of study drug
11) Male patients who are sexually active with a female partner of childbearing potential must agree to practice effective barrier contraception during treatment and for at least 6 months (180 days) following the last dose of study drug.
12) Ability to understand and the willingness to sign a written informed consent document.
13) A minimum life expectancy of 3 months.
14) Accept to comply with all procedures described in the protocol.
Exclusion Criteria:
Patients meeting any of the following exclusion criteria will not be eligible to participate in the study:
1) For patients with NSCLC:
a. Known actionable mutation or rearrangement (including but not limited to epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) gene rearrangements, ROS-1 alterations, or BRAF mutations).
2) For patient with Hepatocellular carcinoma:
a. Hepatic encephalopathy in the past 12 months.
b. Ascites that requires repeated paracentesis in the past 2 months.
c. Main portal vein thrombosis.
d. Active or prior history of gastrointestinal bleeding in the past 12 months.
e. Prior hepatic transplantation.
3) Patients with known spinal cord compression.
4) Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Patients with suspected CNS metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry to rule them out. Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:
– Measurable disease, per RECIST v1.1, must be present outside the CNS.
– The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
– The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
– The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anti-convulsant therapy at a stable dose is permitted.
5) Patients with tumors known to be microsatellite instable (i.e. MSI-High).
6) Prior treatment with systemic therapies that modulate myeloid derived suppressor cells (MDSCs), including but not restricted to anti-colony stimulating factor 1 (CSF-1).
7) Known allergic reactions attributed to compounds of similar product.
8) Patients with any serious underlying medical condition that would impair the patient from receiving or tolerating the planned treatment.
9) Concurrent enrollment in another clinical trial, unless it is an observational (non -interventional) clinical study or the follow-up period of an interventional study.
10) Any concurrent treatment with any anti-cancer therapy including but not restricted to chemotherapy, hormonal therapy, biological therapy or immunotherapy.
11) Systemic treatment with steroids or other immunosuppressive agents within 14 days prior to entry with the exception of intranasal, inhaled, or topical steroid, systemic prednisone at doses not exceeding 10 mg/day (or equivalent) or steroids as premedication for hypersensitivity reaction.
12) Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug
13) Active auto-immune disease within the past 2 years. Patients with vitiligo, alopecia, Grave’s disease, hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded
14) History of adverse events that resulted in permanent discontinuation of prior immunotherapy.
15) ≥ Grade 3 immune-related AE or an immune-related neurologic or ocular AE of any grade while receiving prior immunotherapy. Patients with endocrine AE of ≤ Grade 2 are permitted to enroll if they are stable on appropriate replacement therapy and are asymptomatic. Immune-related AE would include dermatological (e.g. rash, eruptions), gastrointestinal (e.g. colitis, hepatitis, pancreatitis), endocrine (e.g. hypophysitis, thyroid or adrenal insufficiency), respiratory (e.g. pneumonitis), ocular (e.g., uveitis, conjunctivitis), neurological (e.g. paresthesia, myelitis), renal (e.g. renal failure), hematological (e.g. autoimmune cytopenia, red cell aplasia), or mucosal toxicities (e.g. oral mucositis, dry mouth).
16) Patients who have undergone major surgery <28 days prior to starting study drug.
17) Treatment with any conventional or investigational anticancer therapy within 28 days prior to first study product administration.
18) Primary immunodeficiency and/or history of allogenic bone marrow transplantation.
19) Current active infection.
20) Positive test results for human immunodeficiency virus.
21) Patients with a history of other active invasive malignancies during the past three years. Patients with history of other cancer > 3 years prior to enrollment could be enrolled provided that they are considered cured by their treating physician and are not receiving any form of “maintenance” therapy.
22) Pregnant or breastfeeding women.
23) Patients with abnormal cardiac history within 6 months before inclusion or with history of myocardial infarction.
24) Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
Study Contact:
Amy Feist
(952)993-6071
Amy.Feist@parknicollet.com
