An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

August 29, 2019

Primary Completion Date

June 16, 2021

Study Completion Date

April 11, 2023

Conditions
Prostate CancerMetastatic Castration-Resistant Prostate Cancer (mCRPC)
Interventions
DRUG

AZD4635

"In Module 1, participants will receive AZD4635 75 mg capsule orally QD for first 14 days and thereafter will continue to receive 75 mg orally QD Q4W.~In Module 2, participants will receive AZD4635 50 mg / 75 mg capsule orally QD Q2W of 28-day cycle for the first 4 doses and Q4W thereafter.~In both modules, participants will receive treatment until will derive clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurs first."

DRUG

Oleclumab

In Module 2, participants will receive oleclumab 1500 mg IV (solution for infusion after dilution, 50 mg/mL) Q2W of 28-day cycle for the first 4 doses and Q4W thereafter until will derive clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurs first.

DRUG

Durvalumab

In Module 1 after monotherapy of AZD4635, participants will receive durvalumab 1500 mg IV (solution for infusion after dilution, 50 mg/mL) Q4W until will derive clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurs first.

Trial Locations (9)

10032

Research Site, New York

27710

Research Site, Durham

33401

Research Site, West Palm Beach

33705

Research Site, St. Petersburg

33916

Research Site, Fort Myers

37203

Research Site, Nashville

37404

Research Site, Chattanooga

62526

Research Site, Decatur

80218

Research Site, Denver

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY