Suspended
A Phase 2 Study of AbiVERtinib in Combination With Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (Maverick Trial)
What is being tested
Abivertinib
+ Abiraterone
Drug
Who is being recruted
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Over 18 Years
+23 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: September 2025
Summary
Principal SponsorSorrento Therapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2025
Actual date on which the first participant was enrolled.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.
Official TitleA Phase 2 Study of AbiVERtinib in Combination With Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (Maverick Trial)
Principal SponsorSorrento Therapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases
Criteria
8 inclusion criteria required to participate
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
Show More Criteria
15 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalAbiraterone-naive: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.
Group II
ExperimentalAbiraterone-progressing: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Suspended
Suspended
Cleveland Clinic
Cleveland, United StatesSuspended2 Study Centers