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Study to Assess Abivertinib in Combination With Abiraterone in Metastatic Castration Resistant Prostate Cancer | Clinical Trials | Clareo Health

SUSPENDEDPHASE2

Study to Assess Abivertinib in Combination With Abiraterone in Metastatic Castration Resistant Prostate Cancer

A Phase 2 Study of AbiVERtinib in Combination With Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (Maverick Trial)

NCT05361915•Sorrento Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a phase 2, multicenter, open-label study to evaluate the efficacy of abivertinib with abiraterone in patients with metastatic castration-resistant prostate cancer.

Detailed Description

This is a phase 2, multicenter, open-label study to evaluate the efficacy of abivertinib with abiraterone in patients with metastatic castration-resistant prostate cancer via assessment of 6-month radiographic progression-free survival. The study will include two cohorts, abiraterone-naive and abiraterone-progressing.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years of age
•Metastatic disease as identified by imaging
•Progressive mCRPC as defined by: 1) castrate levels of serum testosterone \< 50 ng/dL and 2) progressive disease
•Continued primary androgen deprivation with LHRH analogue (agonist or antagonist) if subject has not undergone bilateral orchiectomy
•Germline testing for HSD3B1. Confirmation of positivity for the adrenal-permissive HSD3B1(1245C) allele (germline heterozygous or homozygous) will be done centrally
•For abiraterone-progressing cohort, abiraterone must be the most immediate preceding line of therapy
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
•Adequate organ and marrow function

Exclusion Criteria

•Significant small cell or neuroendocrine component or histology
•Prior enzalutamide, apalutamide, or darolutamide exposure for either hormone sensitive or CRPC. Prior abiraterone is prohibited for the abiraterone-naïve combination cohort
•Prior BTK inhibitor treatment
•Need for concurrent CYP3A inducers and inhibitors
•Any condition including the presence of laboratory abnormalities that places the patient at unacceptable risk if the patient was to participate in the study
•Corrected QT interval calculated by the Fridericia formula per electrocardiogram within 14 days before Cycle 1 Day 1
•Any uncontrolled active systemic infection including any infection requiring systemic IV treatment that was completed ≤ 7 days before Cycle 1 Day 1, including active infection with COVID-19, defined as 10 days from the end of COVID-19 symptoms
•Have human immunodeficiency virus (HIV) infection, human T-cell leukemia virus type 1 (HTLV1) infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being HBs antigen positive, or anti-HBc-antibody positive), or are positive for HBV deoxyribonucleic acid (DNA). HCV ribonucleic acid (RNA) must be undetectable by laboratory test
•Imminent or established spinal cord compression based on clinical and/or imaging findings
•Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks prior to Cycle 1 Day 1
+4 more criteria

Locations (2)

UCSD Moores Cancer Center

La Jolla, California, United States

Cleveland Clinic

Cleveland, Ohio, United States

Key Dates

Start Date

September 1, 2025

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

March 18, 2024

Enrollment

100

ESTIMATED participants

Conditions

Prostate CancerProstate Cancer Metastatic

Interventions

Abivertinib

DRUG

Abiraterone

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Assess Abivertinib in Combination With Abiraterone in Metastatic Castration Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC