Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Edward Uchio, MD,FACS, CPI

Description

Summary

This is a Phase 1b/2, open-label, multicenter platform trial to evaluate the antitumor activity and safety of etrumadenant (AB928)-based combination therapy in participants with metastatic castrate resistant prostate cancer (mCRPC).

Official Title

A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients With Metastatic Castrate Resistant Prostate Cancer

Details

This study has several treatment arms and each treatment arm has 2 stages. During Stage 1 - Etrumadenant plus zimberelimab (AB122) alone, etrumadenant plus zimberelimab with or without a standard of care treatment (enzalutamide or docetaxel), or etrumadenant plus AB680 with or without zimberelimab will be administered to participants with mCRPC. During Stage 2 - Additional participants with mCRPC may receive an etrumadenant-based combination therapy evaluated in Stage 1 or, a standard of care treatment. A pharmacokinetic (PK) Sub-Study (etrumadenant plus zimberelimab) will be conducted separately. Treatment may continue until unacceptable toxicity or progressive disease, or other reasons specified in the protocol.

Keywords

Prostatic Neoplasms, Castration-Resistant Androgen-Resistant Prostatic Neoplasms Castration Resistant Prostatic Neoplasms Prostatic Cancer, Castration-Resistant Prostatic Neoplasms Neoplasms Docetaxel Etrumadenant Zimberelimab Enzalutamide

Eligibility

For males ages 18 years and up

General Inclusion Criteria:

  • Male participants; age ≥ 18 years
  • Metastatic castrate-resistant prostate cancer while on anti-androgen treatment with castrate levels of testosterone (≤1.7 nmol/L or 50 ng/dL)
  • Measurable or non-measurable disease as per radiographic evaluation
  • Participants with measurable disease may require a fresh tumor biopsy at study entry
  • Performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Adequate hematologic and end-organ function
  • Inclusion Criteria for Participants receiving an enzalutamide-containing treatment
  • Disease progression after prior treatment with abiraterone
  • Inclusion Criteria for Participants receiving a docetaxel-containing treatment
  • Disease progression after prior androgen synthesis inhibitor therapy
  • Inclusion Criteria for all other Participants
  • Disease progression after prior androgen synthesis inhibitor treatment and up to 2 prior lines of taxane chemotherapy

General Exclusion Criteria:

  • Prior treatment with immune checkpoint blockade therapy
  • Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy, within 2-4 weeks prior first study treatment
  • ECG (Electrocardiogram) result with QTcF ≥480 msec
  • Prior stem cell or solid organ transplantation
  • Prior treatment with drugs that stimulate the immune system within 4 weeks prior to first study treatment
  • Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment
  • Received a live, attenuated vaccine within 4 weeks prior to first study treatment, or may need to receive a vaccine during study treatment
  • Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid -CSF (leptomeningeal disease)
  • Prior pulmonary fibrosis, pneumonia, or pneumonitis
  • Cancer other than prostate within 2 years prior to study entry, except for some cancers with a low risk of spreading like non-melanoma skin
  • Prior treatment with an agent targeting the adenosine pathway
  • No oral or IV antibiotics within 2 weeks prior to first study treatment
  • No severe infection within 4 weeks prior to first study treatment
  • No clinically significant cardiac disease
  • Inability to swallow oral medications
  • HIV, Hepatitis B, and C test results negative prior to first study treatment
  • Exclusion Criteria for Participants receiving an enzalutamide-containing treatment
  • Prior treatment with docetaxel, cabazitaxel, or other taxane chemotherapy (prior docetaxel [up to 6 cycles] for hormone-sensitive prostate cancer is allowed if the last dose was at least 6 months prior to study treatment initiation)
  • Prior treatment with enzalutamide or similar therapy other than abiraterone
  • Active or history of autoimmune disease or immune deficiency
  • History of severe allergic reactions to antibody therapy
  • Concomitant use of a medication prohibited by the protocol (including certain transporter substrates as well as known strong CYP3A4 inducers and CYP3A4 inhibitors) within 4 weeks prior to and throughout study treatment
  • Exclusion Criteria for Participants receiving a docetaxel-containing treatment
  • Prior treatment with docetaxel, cabazitaxel, or other taxane chemotherapy
  • Active or history of autoimmune disease or immune deficiency
  • History of severe allergic reactions to antibody therapy
  • Concomitant use of a medication prohibited by the protocol (including certain transporter substrates as well as known strong CYP3A4 inducers and CYP3A4 inhibitors) within 4 weeks prior to and throughout study treatment
  • Exclusion Criteria for all other Participants
  • Prior treatment with 3 or more lines of taxane chemotherapy
  • Active or history of autoimmune disease or immune deficiency
  • History of severe allergic reactions to antibody therapy
  • Concomitant use of a medication prohibited by the protocol (including certain transporter substrates as well as known strong CYP3A4 inducers and CYP3A4 inhibitors) within 4 weeks prior to and throughout study treatment

Locations

  • The University of California, Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • The Oncology Institute of Hope & Innovation accepting new patients
    Whittier California 90603 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arcus Biosciences, Inc.
ID
NCT04381832
Phase
Phase 1/2
Study Type
Interventional
Last Updated