Oral INR731 alone or with androgen receptor blockers for metastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first‑in‑human, open‑label Phase 1 program with three arms: INR731 alone, INR731 plus enzalutamide, and INR731 plus abiraterone. The trial uses dose‑escalation to find safe and tolerable doses and then moves to dose‑expansion cohorts to further explore safety, pharmacokinetics/pharmacodynamics, and preliminary anti‑tumor activity. Single‑agent expansion includes post‑standard‑of‑care mCRPC and patients with shorter time to castration resistance, while combination expansion focuses on first‑line mCRPC without prior mCRPC treatment. Key endpoints are safety, recommended phase 2 dose, PK/PD profiles, and early signs of tumor response.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mass General Hospital
  Boston, Massachusetts, United States Recruiting
• Mary Crowley Cancer Research
  Dallas, Texas, United States Recruiting
• Novartis Investigative Site
  Melbourne, Victoria, Australia Recruiting
• Novartis Investigative Site
  Toronto, Ontario, Canada Recruiting
• Novartis Investigative Site
  Montreal, Quebec, Canada Recruiting
• Novartis Investigative Site
  Würzburg, Bavaria, Germany Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.