PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT ID: NCT04556617

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2022-05-24

Brief Summary

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Conditions

Metastatic Castration-resistant Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1b PLX2853 (20 mg) + Olaparib

Phase 1b dose escalation

Group Type: EXPERIMENTAL

PLX2853 20 mg

Intervention Type: DRUG

PLX2853 tablets

Olaparib

Intervention Type: DRUG

Olaparib tablets

Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone

Phase 1b dose escalation

Group Type: EXPERIMENTAL

Abiraterone acetate

Intervention Type: DRUG

Abiraterone acetate tablets

Prednisone

Intervention Type: DRUG

Prednisone (or equivalent) tablets

PLX2853 40 mg

Intervention Type: DRUG

PLX2853 tablets

Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone

Phase 1b dose escalation

Group Type: EXPERIMENTAL

Abiraterone acetate

Intervention Type: DRUG

Abiraterone acetate tablets

Prednisone

Intervention Type: DRUG

Prednisone (or equivalent) tablets

PLX2853 80 mg

Intervention Type: DRUG

PLX2853 tablets

Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone

Phase 2a dose expansion

Group Type: EXPERIMENTAL

Abiraterone acetate

Intervention Type: DRUG

Abiraterone acetate tablets

Prednisone

Intervention Type: DRUG

Prednisone (or equivalent) tablets

PLX2853 80 mg

Intervention Type: DRUG

PLX2853 tablets

Phase 1b PLX2853 (40 mg) + Olaparib

Phase 1b dose escalation

Group Type: EXPERIMENTAL

Olaparib

Intervention Type: DRUG

Olaparib tablets

PLX2853 40 mg

Intervention Type: DRUG

PLX2853 tablets

Interventions

PLX2853 20 mg

PLX2853 tablets

Intervention Type: DRUG

Olaparib

Olaparib tablets

Intervention Type: DRUG

Abiraterone acetate

Abiraterone acetate tablets

Intervention Type: DRUG

Prednisone

Prednisone (or equivalent) tablets

Intervention Type: DRUG

PLX2853 40 mg

PLX2853 tablets

Intervention Type: DRUG

PLX2853 80 mg

PLX2853 tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years at the time of signing informed consent.

2. Histologically confirmed adenocarcinoma of the prostate with tumor tissue available for molecular analyses.

3. Eastern Cooperative Oncology Group Performance Status 0 to 1.

4. Adequate organ function as demonstrated following laboratory values.

5. Fertile male subjects with female sexual partners must agree to use a highly effective method of birth control during the study and for 90 days after the last dose of study drug.

6. Except as specified above for organ function, all drug-related toxicity from previous cancer therapy (including ongoing Abiraterone Acetate + Prednisone therapy if applicable) must be resolved (to Grade ≤1 or baseline per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0) prior to study treatment administration (Grade 2: alopecia, hot flashes, decreased libido, or neuropathy is allowed).

7. Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements.

Exclusion Criteria

1. Prior exposure to a bromodomain inhibitor.

2. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.

3. Clinically significant cardiac disease.

4. Inability to take oral medication or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption.

5. Active known second malignancy with the exception of any of the following:

• Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin.
• Adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for ≥2 years.
• Any other cancer from which the subject has been disease-free for ≥3 years.

6. Subject is participating in any other therapeutic clinical study (observational or registry studies are allowed).

7. Presence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the study protocol or would interfere with the study endpoints or the subject's ability to participate in the study in the judgment of the Investigator.

8. Receipt of any anti-cancer therapy prior to Cycle 1 Day 1 with less than protocol defined wash-out with the exception of Abiraterone Acetate (for subjects enrolling into Abiraterone Acetate Combination) and GnRH therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Opna Bio LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Chicago

Chicago, Illinois, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Columbia University Medical Center

New York, New York, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Tennessee Oncology/ Sarah Cannon

Nashville, Tennessee, United States

Virginia Cancer Specialist

Fairfax, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

Sarah Cannon Research Institute

London, , United Kingdom

Countries

United States; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PLX124-04

Identifier Type: -

Identifier Source: org_study_id