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

  • STATUS
    Recruiting
  • End date
    Mar 26, 2023
  • participants needed
    72
  • sponsor
    Teneobio, Inc.
Updated on 26 May 2021
Investigator
Ben Buelow, MD, PhD
Primary Contact
Florida Cancer Specialists (5.4 mi away) Contact
+2 other location

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.

Details
Condition Metastatic Castration Resistant Prostate Cancer
Treatment TNB-585
Clinical Study IdentifierNCT04740034
SponsorTeneobio, Inc.
Last Modified on26 May 2021

Eligibility

Yes No Not Sure

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
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