A Phase 1/2 Study of ONCT-534 in Subjects with Relapsed or Refractory Metastatic Castration-Resistant Prostate Cancer

Cancer Categories

Genitourinary (GU)

Karmanos Trial ID

2024-011

NCT ID

NCT05917470

Age Group

Adult

Scope

National

Phase

Phase I/II

Principal Investigator

Elisabeth
Heath, M.D., FACP
Oncology - Medical View Profile

Objective:

Phase 1

Primary Objectives:

To assess the safety, tolerability, and dose-limiting toxicity (DLT) of ONCT-534 at escalating doses.
To determine the MTD of ONCT-534 and inform the 2 dose levels or schedules to be tested in Phase 2.

Secondary Objectives:

To assess the preliminary antitumor activity of ONCT-534.
To assess the PK of ONCT-534

Phase 2

Primary Objectives:

To assess the safety and tolerability of ONCT-534.
To compare 2 dose levels or schedules of ONCT-534 and select the optimal dose for further study.
To assess the preliminary antitumor activity of ONCT-534.

Secondary Objectives:

To correlate antitumor activity of ONCT-534 with AR phenotype.
To assess the pharmacodynamics of ONCT-534.

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Eligibility

Inclusion Criteria:

Subject is ≥18 years of age
Subject has histologically documented metastatic adenocarcinoma of the prostate confirmed by biopsy without neuroendocrine differentiation or small cell features.
Subjects has a history of metastatic CRPC.
Subject has R/R disease following treatment with at least one next-generation AR-signaling inhibitor.
Subject has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or evaluable bony disease. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
Subject has an Eastern Cooperative Oncology Group performance status of 0,1 or 2, and life expectancy of ≥ 6 months.
Subject agrees to take or continue luteinizing hormone-releasing hormone agonist or antagonist therapy or has undergone bilateral orchiectomy.
At least 2 weeks or five half-lives have elapsed, whichever is earliest, since last systemic therapy, including taxanes or other chemotherapy. At least one month has elapsed since systemic therapy with radionuclide pharmaceutical agents
Subject has evidence of disease progression on or after their most recent systemic treatment
Subject has a PSA level ≥ 10 ng/mL, or ≥ 2 ng/mL and ≥ 50% increase from nadir on prior therapy, whichever is lowest.
Subject has serum testosterone < 50 ng/dL.
Subject has adequate renal, hepatic, and pulmonary function
Subject is committed to practice true abstinence, or use a highly effective method of contraception with any female partner of childbearing potential unless documented to be surgically sterile (i.e., vasectomy or bilateral orchiectomy) and to not make semen donations during the study and for 3 months after the last dose of study drug.

Exclusion Criteria:

Subject has small cell prostate cancer or neuroendocrine disease histology, including mixed histology.
Subject has metastases to the brain or central nervous system
Subject is receiving concurrent anti-cancer therapy (including chemotherapy, antibody therapy, immunotherapy, cellular therapy, or other experimental therapies) except for ongoing androgen inhibiting therapy such as luteinizing hormone-releasing hormone (LHRH) agonists. Supportive non-cancer directed therapies such as bisphosphonates or denosumab are allowed.
Subjects taking a strong inhibitor of CYP3A4 or a substrate of CYP2C9 or CYP2C19
Subject had major surgery within 30 days prior to start of study drug.
Subject has current, untreated pathologic long-bone fractures(s), or risk of imminent pathologic fracture(s).
Subject has current or imminent spinal cord compression.
Subject has an active seizure disorder or a history of seizure disorder(s).
Subject has evidence of active human immunodeficiency virus infection, hepatitis B virus (HBV), or hepatitis C virus (HCV)
Subject has any other serious illness or medical condition that would interfere with study participation
Subject has abnormal electrocardiograms (ECGs) that are clinically significant, including average QTcF > 450 ms, or a history of Torsade de Pointes.
Subject has any infection requiring parenteral antibiotic therapy or causing fever (temperature >100.5°F or 38.1°C) within 1 week prior to first dose.
Clinically significant other malignancy with the potential to confound study assessments, with the exception of e.g., treated cutaneous squamous cell and basal carcinomas, non-muscle invasive bladder cancer, Rai Stage 0 CLL, and adequately treated Stage 1 to 2 non-cutaneous malignancy in remission for 5 years.
Subject is unable to comply with the protocol and/or not willing or not available for follow-up assessments

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