NCT07570979 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
| NCT ID | NCT07570979 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Metastatic Castration-resistant Prostate Cancer (mCRPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2026-05-25 |
| Primary Completion | 2030-06-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 208 participants in total. It began in 2026-05-25 with a primary completion date of 2030-06-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07570979 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Castration-resistant Prostate Cancer (mCRPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07570979 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07570979 currently recruiting?
Yes, NCT07570979 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07570979 trial being conducted?
This trial is being conducted at Dallas, United States, Melbourne, Australia.
Who is sponsoring the NCT07570979 clinical trial?
NCT07570979 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 208 participants.
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