A Study of TNB-585 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-585, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of TNB-585 monotherapy in subjects with mCRPC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teneobio, Inc.

Criteria

Inclusion Criteria:

• Pathologically confirmed prostatic adenocarcinoma.

• History of metastatic disease.

• Chemically or surgically castrate.

• Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations.

• HIV, HBV, and/or HCV-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

• An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

• Subject must have adequate heart, liver, bone marrow and kidney function (e.g. eGFR ≥ 30 mL/min, AST/ALT ≤ 3 x ULN, Hgb ≥ 9 g/dL, Plt ≥ 100,000 / mm3, ANC ≥ 1500 / mm3).

Exclusion Criteria:

• Subject has been diagnosed with or treated for another malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.

• History of neuroendocrine differentiation in the subject's disease.

• Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed.

• Subject has clinically significant CNS pathology.

• Subject requires chronic immunosuppressive therapy.

• Subject has a history of major cardiac abnormalities.