Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arcus Biosciences, Inc.
• Treatments: Docetaxel

Criteria

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