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

NCT05361915 | Suspended Phase 2 FDA Drug

• 1 other identifier: ABV-RPC-201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer; Prostate Cancer Metastatic

Keywords

metastatic prostate cancer; castration-resistant prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline through study completion at up to approximately 63 months

Secondary Outcomes (8)

• Overall Response Rate

  baseline through study completion at up to approximately 63 months

• Duration of response

  baseline through study completion at up to approximately 63 months

• Prostate-Specific Antigen (PSA) progression

  baseline through study completion at up to approximately 63 months

• Safety and tolerability

  baseline through study completion at up to approximately 63 months

• Time to occurrence of first skeletal event

  baseline through study completion at up to approximately 63 months

Study Arms (2)

Abivertinib - Abiraterone-naive

EXPERIMENTAL

Abiraterone-naive: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.

Drug: Abivertinib; Drug: Abiraterone

Abivertinib - Abiraterone-progressing

EXPERIMENTAL

Abiraterone-progressing: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.

Drug: Abivertinib; Drug: Abiraterone

Interventions

Abivertinib DRUG

Abivertinib is a small molecule inhibitor

Also known as: STI-5656

Abivertinib - Abiraterone-naive; Abivertinib - Abiraterone-progressing

Abiraterone DRUG

Hormone-based chemotherapy

Abivertinib - Abiraterone-naive; Abivertinib - Abiraterone-progressing

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (2)

UCSD Moores Cancer Center

La Jolla, California, 92037, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abivertinib; abiraterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 5, 2022
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

US (2)