NCT05551117PHASE2TERMINATED

A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors

A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

Sponsor: MacroGenics

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Castration-Resistant Prostatic Cancer, Androgen-Independent Prostatic Cancer, Androgen-Insensitive Prostatic Cancer, Androgen-Resistant Prostatic Cancer, Hormone Refractory Prostatic Cancer

Interventions

vobramitamab duocarmazine 2.0 mg (Arm A), vobramitamab duocarmazine 2.7 mg (Arm B), vobramitamab duocarmazine, Abiraterone

Enrollment

192 participants

Primary completion

Jul 2024

Study completion

Jan 2025

First posted

Sep 2022

Last updated

Feb 2026

Primary Endpoints (CT.gov)

Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator

Time frame: Assessed every 8 weeks for six months. Six month data reported.

Part 2: Objective Response Rate (ORR) Per Investigator Assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Criteria

Time frame: Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.

Secondary Endpoints

Part 1: ORR Per PCWG3 Criteria as Determined by the Investigator

Part 1: Median Duration of Response (DoR) Per PCWG3 Criteria as Determined by the Investigator

Part 1: Mean Best Tumor Size Change Over Time

Eligibility Criteria

Inclusion Criteria: * Part 1 only: Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features. * Part 2 only: Histologically confirmed SCC or the anus, melanoma, HNSCC, squamous NSCLC, or SCLC. * Part 1 only: Received 1 prior ARAT for metastatic or non-metastatic, castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of \<60 days used as bridging to lutetium-177 is permitted. Up to 3 total prior lines of therapy for mCRPC are permitted.. * Part 2 only: At least 1 prior line of systemic therapy for unresectable or metastatic disease and no more than 2 prior lines of cytotoxic chemotherapy. Participants with HNSCC or melanoma must have received prior PD-1 or PD-L1 inhibitor for advanced or metastatic disease. * All participants must have ≥ 1 metastatic lesion, according to RECIST 1.1 or PCWG3 criteria, that is present on magnetic resonance imaging (MRI), computed tomography…

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov