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.
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
Drug | Synonyms | Arms |
---|
TNB-585 | | Dose 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
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | Sequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified. | |
Dose Expansion | Experimental | An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established. | |
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