For Healthcare Professionals

Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

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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).
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Who can take part

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

INCLUSION CRITERIA

General 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


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

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 - CSF (leptomeningeal disease)
  9. Prior pulmonary fibrosis, pneumonia, or pneumonitis
  10. 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
  11. Prior treatment with an agent targeting the adenosine pathway
  12. No oral or IV antibiotics within 2 weeks prior to first study treatment
  13. No severe infection within 4 weeks prior to first study treatment
  14. No clinically significant cardiac disease
  15. Inability to swallow medications

Exclusion Criteria for Participants receiving an enzalutamide-containing treatment


  1. 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)
  2. Prior treatment with enzalutamide or similar therapy other than abiraterone
  3. Active or history of autoimmune disease or immune deficiency
  4. History of severe allergic reactions to antibody therapy
  5. 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


  1. Prior treatment with docetaxel, cabazitaxel, or other taxane chemotherapy
  2. Active or history of autoimmune disease or immune deficiency
  3. History of severe allergic reactions to antibody therapy
  4. 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


  1. Prior treatment with docetaxel, cabazitaxel, topoisomerase 1 inhibitors, or other taxane chemotherapy
  2. Active or history of autoimmune disease or immune deficiency
  3. History of severe allergic reactions to antibody therapy
  4. 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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Prostatic Neoplasms, Castration-Resistant,Androgen-Resistant Prostatic Neoplasms,Castration Resistant Prostatic Neoplasms,Prostatic Cancer, Castration-Resistant

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

173

Est. Completion Date

Apr 30, 2024

Treatment type

Interventional


Sponsor

Arcus Biosciences, Inc.

ClinicalTrials.gov identifier

NCT04381832

Study number

ARC-6

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