Actively Recruiting
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
Led by Novartis Pharmaceuticals · Updated on 2026-05-06
208
Participants Needed
2
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care androgen receptor pathway inhibitors (ARPIs) in adult patients with metastatic prostate cancer.
CONDITIONS
Official 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...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Histological or cytological confirmation of prostate adenocarcinoma; mixed histology allowed if adenocarcinoma is majority
- At least one metastatic lesion confirmed by CT, MRI, or bone scan within 28 days before treatment start
- Castrate level of serum or plasma testosterone (<50 ng/dL or <1.7 nmol/L)
- Ongoing androgen deprivation therapy via orchiectomy or GnRH analog/inhibitor
- Metastatic castration-resistant prostate cancer patients who progressed on or are not candidates for standard of care
- Prior treatment with taxane, PARP inhibitors, or lutetium Lu 177 vipivotide tetraxetan allowed
- Combination expansion patients must be first-line mCRPC with no prior mCRPC treatment; prior metastatic hormone-sensitive prostate cancer treatment allowed
You will not qualify if you...
- Younger than 18 years old
- Non-adenocarcinoma prostate cancer diagnosis
- Biochemical recurrence only or no evidence of metastatic disease on imaging
- Prior treatment with cereblon-based degraders
- HIV positive or immune compromised patients
- Use of drugs that prolong QT interval unless permanently stopped during the study
- Received investigational agents within 7 days or 5 half-lives before starting treatment
- Other protocol-defined exclusion criteria may apply
AI-Screening
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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
CONTACT
N
Novartis Pharmaceuticals
CONTACT
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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