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

Recruiting now · Phase 1

Conditions studied: Metastatic Castration-resistant Prostate Cancer (mCRPC)

In brief

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.

Key facts

Study ID

NCT07570979

Run by

Novartis Pharmaceuticals

People needed

208

Starts

2026-05-25

Expected to finish

2030-06-03

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.
• Participants must have histological and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are eligible as long as the non-adenocarcinoma feature is the minority component.
• At least 1 metastatic lesion (according to local radiology assessment by the investigator) present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to Cycle 1 Day 1 (C1D1).
• Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
• Ongoing androgen deprivation therapy (ADT) either via orchiectomy and/or ongoing gonadotropin-releasing hormone (GnRH) analog or inhibitor is allowed.
• Participants must be mCRPC patients who have either progressed on or are not candidates for other SOC. Prior taxane, poly(ADP) ribose polymerase (PARP) inhibitor, and lutetium Lu 177 vipivotide tetraxetan (Pluvicto) are allowed. Combination expansion patients, however, must be 1L mCRPC with no prior treatment in the mCRPC setting. Treatment within the mHSPC setting does not affect eligibility.

You may not qualify if…

• Age < 18 years old.
• Histological and/or cytological confirmation of non-adenocarcinoma of the prostate.
• Patients with biochemical recurrence only or those without evidence of metastatic disease by radiographical imaging (CT/MRI or bone scan) are not eligible.
• Patients previously treated with a cereblon-based degrader.
• Patients who are HIV+ or immune compromised.
• Use of agents known to prolong QT interval unless they can be permanently discontinued for the duration of the study
• Treatment with an investigational agent within 7 days (or 5 half-lives, whichever is longer) of the anticipated Cycle 1 Day 1 (C1D1).
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Mary Crowley Cancer Research — Dallas, Texas, United States (enrolling)
• Novartis Investigative Site — Melbourne, Victoria, Australia (enrolling)
• Novartis Investigative Site — Hirakata, Osaka, Japan (enrolling)

Full record on ClinicalTrials.gov

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