Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

  • STATUS
    Recruiting
  • participants needed
    140
  • sponsor
    Arcus Biosciences, Inc.
Send
Updated on 19 February 2024
See if I qualify
cancer
measurable disease
docetaxel
taxane
combination therapy
testosterone
enzalutamide
antiandrogen therapy
antiandrogens
combined modality therapy
castration-resistant prostate cancer
prostate cancer
prostatic neoplasms, castration-resistant
prostatic neoplasm

Summary

This is a Phase 1b/2, open-label, multicenter platform trial to evaluate the antitumor activity and safety of AB928-based combination therapy in participants with metastatic castrate resistant prostate cancer (mCRPC).

Description

This study has several treatment arms and each treatment arm has 2 stages. During Stage 1 - AB928 plus zimberelimab alone, AB928 plus zimberelimab with or without a standard of care treatment (enzalutamide or docetaxel), or AB928 plus AB680 with or without zimberelimab will be administered to participants with mCRPC.

During Stage 2 - Additional participants with mCRPC may receive an AB928-based combination therapy evaluated in Stage 1 or, a standard of care treatment.

A pharmacokinetic (PK) Sub-Study (AB928 plus zimberelimab) will be conducted separately.

Treatment may continue until unacceptable toxicity or progressive disease, or other reasons specified in the protocol.

Details
Condition Malignant neoplasm of prostate, Prostatic Neoplasms, Castration-Resistant, Prostatic Cancer, Castration-Resistant
Age 18years - 100years
Treatment Zimberelimab, AB928, Docetaxel, Enzalutamide, AB680
Clinical Study IdentifierNCT04381832
SponsorArcus Biosciences, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

cancer
measurable disease
docetaxel
taxane
combination therapy
testosterone
enzalutamide
antiandrogen therapy
antiandrogens
combined modality therapy
castration-resistant prostate cancer
prostate cancer
prostatic neoplasms, castration-resistant
prostatic neoplasm

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.