RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT07570979

Registry updated: 2026-10-20

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Description

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.

Interventions

INR731 (Drug)
Oral administration
Enzalutamide (Drug)
Oral administration
Abiraterone (Drug)
Oral administration
Androgen deprivation therapy (ADT) (Drug)
Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Locations

Mass General Hospital — Boston, Massachusetts, United States
Mary Crowley Cancer Research — Dallas, Texas, United States
Novartis Investigative Site — Melbourne, Victoria, Australia
Novartis Investigative Site — Toronto, Ontario, Canada
Novartis Investigative Site — Montreal, Quebec, Canada
Novartis Investigative Site — Würzburg, Bavaria, Germany
Novartis Investigative Site — Dresden, Saxony, Germany
Novartis Investigative Site — Hirakata, Osaka, Japan
Novartis Investigative Site — Seoul, South Korea
Novartis Investigative Site — Seoul, South Korea
Novartis Investigative Site — Valencia, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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