Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

STATUS

Recruiting
participants needed

140
sponsor

Arcus Biosciences, Inc.

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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	18-100 years
Treatment	Zimberelimab, AB928, Docetaxel, Enzalutamide, AB680
Clinical Study Identifier	NCT04381832
Sponsor	Arcus Biosciences, Inc.
Last Modified on	19 February 2024

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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

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Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer