Actively Recruiting
An Open-label, Multi-center Study of Oral INR731 Alone or With Androgen Receptor Pathway Inhibitors in Men With Metastatic Prostate Cancer
Led by Novartis Pharmaceuticals · Updated on 2026-05-28
208
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary anti-tumor activity, and recommended dosing of INR731 alone or combined with standard androgen receptor pathway inhibitors (ARPIs) in adult men with metastatic prostate cancer. This first-in-human, open-label, phase I study focuses on patients with metastatic castration-resistant prostate cancer (mCRPC) and aims to explore how INR731 works in different treatment settings. The trial includes three treatment arms: INR731 alone (Arm A), INR731 combined with enzalutamide (Arm B), and INR731 combined with abiraterone (Arm C). Each arm has a dose escalation phase followed by a dose expansion phase to further assess safety and preliminary anti-tumor effects. Patients may continue androgen deprivation therapy (ADT) as part of standard care. Combination arms focus on patients with mCRPC who have progressed after standard care or are treatment-naive in the mCRPC setting. Participants will undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, dose interruptions, and dose intensity over up to 24 months. Researchers will measure overall response rates, disease control, progression-free survival, and drug plasma levels. Imaging scans, laboratory tests, and clinical evaluations will be done throughout to track treatment effects and safety. The study is expected to last until 2030, with ongoing follow-up for safety and outcomes.
CONDITIONS
Brief Title
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with ECOG Performance Status of 2 or less
- Histological or cytological confirmation of prostate adenocarcinoma
- At least one metastatic lesion confirmed by recent CT, MRI, or bone scan within 28 days before treatment
- Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)
- Ongoing androgen deprivation therapy via orchiectomy or hormone therapy
- Metastatic castration-resistant prostate cancer with progression after or not candidates for standard care
- Prior treatments including taxane, PARP inhibitors, or lutetium Lu 177 vipivotide tetraxetan (Pluvicto) allowed
- For combination expansion, patients must be first-line metastatic castration-resistant prostate cancer with no prior treatment in this setting
- Treatment within metastatic hormone-sensitive prostate cancer setting does not affect eligibility
You will not qualify if you...
- Age under 18 years
- Non-adenocarcinoma histology of the prostate
- Biochemical recurrence only or no evidence of metastatic disease by imaging
- Prior treatment with cereblon-based degraders
- HIV positive or immune compromised status
- Use of medications that prolong QT interval unless permanently discontinued during study
- Treatment with investigational agents within 7 days or 5 half-lives before starting study
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until dose escalation is completed.
Participants may undergo a dose escalation phase to determine the recommended dose of INR731 alone or in combination with other drugs.
Weekly or biweekly visits during dose escalation depending on treatment arm
Duration - Up to approximately 24 months
Participants receive oral INR731 alone or in combination with enzalutamide or abiraterone for metastatic castration-resistant prostate cancer.
Regular visits for dosing and safety assessments approximately every 28 days
Duration - Up to approximately 24 months
Participants are monitored for adverse events, treatment tolerability, and clinical outcomes after treatment ends.
Visits scheduled based on participant status after treatment completion
Trial Site Locations
Total: 2 locations
1
Mary Crowley Cancer Research
Dallas, Texas, United States, 75251
Actively Recruiting
2
Novartis Investigative Site
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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