A Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants with Metastatic Castration-resistant Prostate Cancer (TAMARACK)

Phase 1

Recruiting

• Conditions: Metastatic Castration-resistant Prostate Cancer; MedDRA version: 20.0Level: LLTClassification code: 10036921Term: Prostate carcinoma Class: 10029104; MedDRA version: 21.1Level: LLTClassification code: 10076506Term: Castration-resistant prostate cancer Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-501078-20-00
• Lead Sponsor: Macrogenics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features, Participants must have = 1 metastatic lesion that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained = 28 days prior to initiation of study treatment, Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria, Received 1 prior ARAT for metastatic or non-metastatic, castrationsensitive or castration-resistant prostate cancer. A second ARAT regimen of < 60 days used as bridging to lutetium-177 is permitted., Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs, Acceptable physical condition and laboratory value

Exclusion Criteria

Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures, Received > 3 total prior therapies for mCRPC., Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of < 60 days used as bridging for lutetium-177 is permitted., Another hematologic or solid tumor = stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy = 2 years from first dose of study treatment. Participants who had curative therapy for localized malignancy are eligible, Untreated, symptomatic central nervous system (CNS) metastasis, Prior treatment with any B7-H3 targeted agent for cancer, Contraindications to the use of corticosteroid treatment, Prior stem cell, tissue, or solid organ transplant, Use of products that have published anti-prostate cancer activity or are known to decrease PSA., Participants with a known history of BRCA mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified