About the study

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).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Male participants; age ≥ 18 years
2. Metastatic castrate-resistant prostate cancer while on anti-androgen treatment with castrate levels of testosterone (≤1.7 nanomoles per liter [nmol/L] or 50 nanograms per deciliter [ng/dL])
3. Measurable or non-measurable disease as per radiographic evaluation
4. Participants with measurable disease may require a fresh tumor biopsy at study entry
5. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
6. Life expectancy of at least 3 months
7. Adequate hematologic and end-organ function
8. Human immunodeficiency virus (HIV), Hepatitis B, and C test results negative prior to first study treatment Inclusion Criteria for Participants receiving an enzalutamide-containing treatment
9. Disease progression after prior treatment with abiraterone Inclusion Criteria for Participants receiving a docetaxel-containing treatment
10. Disease progression after prior androgen synthesis inhibitor therapy Inclusion Criteria for all other Participants
11. Disease progression after prior androgen synthesis inhibitor treatment and up to 2 prior lines of taxane chemotherapy General

Exclusion criteria

1. Prior treatment with immune checkpoint blockade therapy
2. Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy, within 2-4 weeks prior first study treatment
3. Corrected QT interval (QTc) ≥480 msec using Fredericia's QT correction formula (based on an average of triplicate recordings)
4. Prior allogeneic stem cell or solid organ transplantation
5. Prior treatment with drugs that stimulate the immune system within 4 weeks prior to first study treatment
6. Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment
7. Received a live, attenuated vaccine within 4 weeks prior to first study treatment, or may need to receive a vaccine during study treatment
8. Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid
9. CSF (leptomeningeal disease)
10. Prior pulmonary fibrosis, pneumonia, or pneumonitis
11. 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
12. Prior treatment with an agent targeting the adenosine pathway
13. No oral or IV antibiotics within 2 weeks prior to first study treatment
14. No severe infection within 4 weeks prior to first study treatment
15. No clinically significant cardiac disease
16. Inability to swallow medications Exclusion Criteria for Participants receiving an enzalutamide-containing treatment
17. 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)
18. Prior treatment with enzalutamide or similar therapy other than abiraterone
19. Active or history of autoimmune disease or immune deficiency
20. History of severe allergic reactions to antibody therapy
21. 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
22. Prior treatment with docetaxel, cabazitaxel, or other taxane chemotherapy
23. Active or history of autoimmune disease or immune deficiency
24. History of severe allergic reactions to antibody therapy
25. 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
26. Prior treatment with docetaxel, cabazitaxel, topoisomerase 1 inhibitors, or other taxane chemotherapy
27. Active or history of autoimmune disease or immune deficiency
28. History of severe allergic reactions to antibody therapy
29. 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

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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