Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer
a study on Prostate Cancer Metastatic Castration-Resistant Prostate Cancer
Summary
- Eligibility
- for males ages 18 years and up (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
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, San Francisco
not yet accepting patients
San Francisco California 94158 United States - The University of California, Los Angeles
accepting new patients
Encino California 91436 United States
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