Oral INR731 alone or with androgen receptor blockers for metastatic castration-resistant prostate cancer
An Open-label, Multi-center, First in Human Phase I Global Dose Escalation and Expansion Study of INR731 Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer
This tests whether oral INR731 by itself or with androgen receptor pathway inhibitors is safe, tolerable, and shows early anti‑tumor activity in adults with metastatic castration‑resistant prostate cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Novartis Industry-sponsored |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT07570979 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with histologically confirmed metastatic castration‑resistant prostate adenocarcinoma, castrate testosterone levels, at least one metastatic lesion, ECOG performance status 0–2, and who have progressed on or are not candidates for standard therapies are the intended participants.
Not a fit: Patients with poor performance status (ECOG >2), dominant neuroendocrine prostate cancer, uncontrolled comorbidities, or those seeking immediate curative treatment are unlikely to benefit from this early-phase, safety-focused trial.
Why it matters
Potential benefit: If successful, INR731 could become a new oral option that delays progression or improves disease control alone or when added to standard androgen receptor pathway inhibitors.
How similar studies have performed: This is the first-in-human trial of INR731 so there are no prior clinical data on this agent, although combining new targeted agents with androgen receptor pathway inhibitors has produced mixed but occasionally meaningful benefits in mCRPC.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dallas, Texas and 1 other locations
- Mary Crowley Cancer Research — Dallas, Texas, United States (Recruiting)
- Novartis Investigative Site — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.