Clinical trial · Interventional
Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer
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
NCT04381832CI-TRIAL-00092458completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Androgen-Resistant Prostatic Neoplasms | — | UNRESOLVED | — |
| Castration Resistant Prostatic Neoplasms | — | UNRESOLVED | — |
| Prostatic Cancer, Castration-Resistant | — | UNRESOLVED | — |
| Prostatic Neoplasms, Castration-Resistant | Prostate Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Etrumadenant | Drug | — | UNRESOLVED |
| Quemliclustat | Drug | — | UNRESOLVED |
| SG | Drug | — | UNRESOLVED |
| Zimberelimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamide
- description
- Participants will receive oral etrumadenant in combination with intravenous (IV) zimberelimab and standard oral enzalutamide
- interventionNames
- Drug: Etrumadenant
- Drug: Zimberelimab
- Drug: Enzalutamide
- type
- ACTIVE_COMPARATOR
- label
- Stage 2: enzalutamide
- description
- Participants will receive standard oral enzalutamide
- interventionNames
- Drug: Enzalutamide
- type
- EXPERIMENTAL
- label
- Stage 1 and 2: Etrumadenant + zimberelimab + docetaxel
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 nanomoles per liter \[nmol/L\] or 50 nanograms per deciliter \[ng/dL\]) * Measurable or non-measurable disease as per radiographic evaluation * Participants with measurable disease may require a fresh tumor biopsy at study entry * Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 * Life expectancy of at least 3 months * Adequate hematologic and end-organ function * 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 * 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 * Corrected QT interval (QTc) ≥480 msec using Fredericia's QT correction formula (based on an average of triplicate recordings) * Prior allogeneic 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 medications 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 docetaxel, cabazitaxel, topoisomerase 1 inhibitors, 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
References
Publications (0)
Data not yet available
No reference posted for this study.