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Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

Trial Status: Active

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

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

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

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: Kathryn Hilburn
Phone: 310-633-8400

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

This study has several treatment arms and each treatment arm has 2 stages. During Stage 1 - AB928 plus zimberelimab alone, AB928 plus zimberelimab with or without a standard of care treatment (enzalutamide or docetaxel), or AB928 plus AB680 with or without zimberelimab will be administered to participants with mCRPC. During Stage 2 - Additional participants with mCRPC may receive an AB928-based combination therapy evaluated in Stage 1 or, a standard of care treatment. A pharmacokinetic (PK) Sub-Study (AB928 plus zimberelimab) will be conducted separately. Treatment may continue until unacceptable toxicity or progressive disease, or other reasons specified in the protocol.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Arcus Biosciences, Inc.

  • Primary ID ARC-6
  • Secondary IDs NCI-2020-04162
  • Clinicaltrials.gov ID NCT04381832