A Study of Lorigerlimab with Docetaxel or Docetaxel Alone in Participants with Metastatic Castration-Resistant Prostate Cancer

Phase 1

Recruiting

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

• Registration Number: CTIS2022-502982-49-00
• Lead Sponsor: Macrogenics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-02
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

Metastatic castration-resistant adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features., Participants must have = 1 metastatic (measurable or non-measurable per PCWG3) lesion., Participant has prostate cancer progression at study entry based on PCWG3 criteria., Participant shows evidence of disease progression after receiving at least 1 prior androgen receptor axis-targeted therapy (ARAT) regimen (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide)., Patients with known history of documented breast cancer gene (BRCA) mutation (germline or somatic) must have received an approved poly ADP ribose polymerase (PARP) inhibitor regimen., Participants must have adequate performance status, life expectancy and laboratory values.

Exclusion Criteria

Any condition preventing participant’s ability to receive, tolerate, or comply with the planned treatment or study procedures., Received prior chemotherapy for mCRPC or prior treatment with checkpoint inhibitors for prostate cancer., Current active or chronic infections., Any clinically significant heart, lung, or gastrointestinal disorders., Allergy to any of the study treatments or components of the study treatments.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of lorigerlimab+docetaxel versus docetaxel as measured by rPFS.;Secondary Objective: To evaluate the efficacy of lorigerlimab+docetaxel versus docetaxel as measured by objective response assessments., To evaluate the efficacy of lorigerlimab+docetaxel versus docetaxel as measured by PSA levels., To characterize the safety/tolerability profile of lorigerlimab+docetaxel versus docetaxel., To evaluate the efficacy of lorigerlimab+docetaxel versus docetaxel as measured by OS., To characterize the PK of lorigerlimab., To characterize immunogenicity of lorigerlimab., To evaluate QOL outcomes associated with lorigerlimab+docetaxel versus docetaxel as measured by disease-related symptoms and participant-reported outcomes.;Primary end point(s): Median radiographic progression free survival (rPFS) determined by investigator review.