Clinical Trials /

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

NCT04740034

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of TNB-585 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
  • Official Title: A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-585, a Bispecific Antibody Targeting PSMA in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: TNB585.001
  • NCT ID: NCT04740034

Conditions

  • Metastatic Castration-resistant Prostate Cancer

Interventions

DrugSynonymsArms
TNB-585Dose Escalation

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalSequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified.
  • TNB-585
Dose ExpansionExperimentalAn expansion cohort in subjects with mCRPC will be enrolled after RP2D is established.
  • TNB-585

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of subjects with Dose-limiting toxicities (DLT)
Time Frame:21 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Anti-tumor activity by objective response rate (ORR)
Time Frame:24 months
Safety Issue:
Description:Objective response rate is defined as the proportion of subjects with a confirmed partial or complete response to treatment
Measure:Anti-tumor activity by progression free survival (PFS)
Time Frame:24 months
Safety Issue:
Description:Progression-free survival time is defined as the time from the first dose of TNB-585 to progression or death, whichever occurs first
Measure:Anti-tumor activity by duration of objective response (DOR)
Time Frame:24 months
Safety Issue:
Description:The duration of objective response for a subject is defined as the time from the initial objective response to disease progression or death, whichever occurs first
Measure:PSA50
Time Frame:24 months
Safety Issue:
Description:Percentage of subjects that achieve a reduction of ≥ 50% in prostate specific antigen (PSA)
Measure:PSA30
Time Frame:24 months
Safety Issue:
Description:Percentage of subjects that achieve a reduction of ≥ 30% in prostate specific antigen (PSA)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Teneobio, Inc.

Trial Keywords

  • Prostate specific membrane antigen
  • PSMA
  • Prostate cancer
  • Metastatic
  • Castrate-resistant

Last Updated

May 18, 2021