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
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
