Prostate CancerPhase 2NCT05361915
Study to Assess Abivertinib in Combination With Abiraterone in Metastatic Castration Resistant Prostate Cancer
A Phase 2 study testing Abivertinib and Abiraterone in people with Prostate Cancer and Prostate Cancer Metastatic, run by Sorrento Therapeutics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic
- What is being tested?
- Abivertinib and Abiraterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2025to Jan 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
- Major surgery within 4 weeks before Cycle 1 Day 1. Minor surgeries within 10 days before Cycle 1 Day 1. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
- Radiation therapy within 2 weeks before Cycle 1 Day
- Participation in another investigational trial and received treatment within 4 weeks before Cycle 1 Day 1
- Any other active malignancy at the time of first dose of study treatment or diagnosis of another malignancy within 2 years prior to Cycle 1 Day 1 that requires active treatment, except locally curable cancers
- Unable to swallow tablets/capsules whole
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44195
UCSD Moores Cancer Center
La Jolla, California, 92037
About this study
Official title: A Phase 2 Study of AbiVERtinib in Combination With Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (Maverick Trial)
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.
Read the 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.
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Being tested
- Abivertinib, Abiraterone
- Keywords
- metastatic prostate cancer, castration-resistant prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbivertinibDrug
Also called STI-5656
Abivertinib is a small molecule inhibitor
AbirateroneDrug
Hormone-based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Abivertinib - Abiraterone-naive | Experimental | Abiraterone-naive: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily. Receives: Drug: Abivertinib; Drug: Abiraterone |
| Abivertinib - Abiraterone-progressing | Experimental | Abiraterone-progressing: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily. Receives: Drug: Abivertinib; Drug: Abiraterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month radiographic progression-free survival
6-month radiographic progression-free survival (rPFS) will be assessed as defined by percent of subjects alive and without progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases.
Measured: baseline through study completion at up to approximately 63 months
Secondary outcomes (8)
Overall Response Rate
Overall Response Rate (ORR) will be defined by percent of subjects alive and without progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: baseline through study completion at up to approximately 63 months
Duration of response
duration of response will be defined as the time from the first documented response in patients with measurable disease to the date of progression or death due to any cause.
Measured: baseline through study completion at up to approximately 63 months
Prostate-Specific Antigen (PSA) progression
Change in PSA as compared to baseline as defined by Prostate Cancer Working Group 3 (PCWG3) criteria
Measured: baseline through study completion at up to approximately 63 months
Safety and tolerability
Safety and tolerability of abivertinib with abiraterone using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria.
Measured: baseline through study completion at up to approximately 63 months
Time to occurrence of first skeletal event
Time to occurrence of first symptomatic skeletal event will be defined as the time from enrollment to the first symptomatic skeletal event defined as use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumor related orthopedic surgical intervention.
Measured: baseline through study completion at up to approximately 63 months
Time to first subsequent anti-cancer therapy
Time to first subsequent anti-cancer therapy will be defined as the time from treatment discontinuation for any reason to start of subsequent anti-cancer therapy or death.
Measured: baseline through study completion at up to approximately 63 months
6-month radiographic progression-free survival (rPFS)
6-month radiographic progression-free survival (rPFS) will be defined as the time from enrollment to progression by by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases or death, whichever occurs first.
Measured: baseline through study completion at up to approximately 63 months
Overall survival
Overall survival will be defined as the time from enrollment to death
Measured: baseline through study completion at up to approximately 63 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study startSep 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Why it stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361915
- Sponsor's protocol ID
- ABV-RPC-201
- Status last verified
- Mar 2024
- First submitted
- 15 Apr 2022
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of AbiVERtinib in Combination With Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (Maverick Trial)
- ClinicalTrials.gov ID
- NCT05361915
- Acronym / sponsor ID
- ABV-RPC-201
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Keywords
- metastatic prostate cancer, castration-resistant prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abivertinib - Abiraterone-naive | Experimental | Drug: Abivertinib, Drug: AbirateroneAbiraterone-naive: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily. |
| Abivertinib - Abiraterone-progressing | Experimental | Drug: Abivertinib, Drug: AbirateroneAbiraterone-progressing: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbivertinibAlso: STI-5656Abivertinib is a small molecule inhibitor | Drug | Abivertinib - Abiraterone-naive, Abivertinib - Abiraterone-progressing |
| AbirateroneHormone-based chemotherapy | Drug | Abivertinib - Abiraterone-naive, Abivertinib - Abiraterone-progressing |
Primary outcome
6-month radiographic progression-free survival
Time frame: baseline through study completion at up to approximately 63 months
6-month radiographic progression-free survival (rPFS) will be assessed as defined by percent of subjects alive and without progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases.
8 secondary outcomes
Overall Response Rate
Time frame: baseline through study completion at up to approximately 63 months
Duration of response
Time frame: baseline through study completion at up to approximately 63 months
Prostate-Specific Antigen (PSA) progression
Time frame: baseline through study completion at up to approximately 63 months
Safety and tolerability
Time frame: baseline through study completion at up to approximately 63 months
Time to occurrence of first skeletal event
Time frame: baseline through study completion at up to approximately 63 months
Time to first subsequent anti-cancer therapy
Time frame: baseline through study completion at up to approximately 63 months
6-month radiographic progression-free survival (rPFS)
Time frame: baseline through study completion at up to approximately 63 months
Overall survival
Time frame: baseline through study completion at up to approximately 63 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Royal, MD study director
Sorrento Therapeutics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abivertinib and Abiraterone in people with Prostate Cancer and Prostate Cancer Metastatic, run by Sorrento Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month radiographic progression-free survival (time frame: baseline through study completion at up to approximately 63 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.