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Study of INR731 in Metastatic Prostate Cancer

This study is looking at a new drug called INR731, given alone or with other standard prostate cancer medicines like enzalutamide or abiraterone. It's for men with metastatic castration-resistant prostate cancer (mCRPC), meaning their prostate cancer has spread and is no longer responding to hormone therapy. The main goal is to see if INR731 is safe and how well people tolerate it, by tracking side effects and how often doses need to be changed. Researchers will also look at how the drug moves through the body and if it shows any early signs of shrinking tumors. You might be able to join if you are a man aged 18 or older with confirmed prostate cancer and a good general health status (ECOG Performance Status ≤2). The study is currently recruiting 208 participants.

Study design
This is an open-label, first-in-human study, meaning you and your doctors will know which treatment you are receiving. It involves three groups: INR731 alone, or INR731 combined with enzalutamide or abiraterone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Side effects and dose changes will be monitored for up to approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~208 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:INR731EnzalutamideAbirateroneAndrogen deprivation therapy (ADT)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of dose-limiting toxicities (DLTs)
Measured over 28 days
+3 more outcomes measured

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Explore related trials

Prostate Carcinoma

Where it's being run

3 sites across 3 states
Texas1
Victoria1
Osaka1

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Incidence and severity of dose-limiting toxicities (DLTs)28 days

    A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 that occurs within the first 28 days and not clearly and incontrovertibly assessed as due to disease progression, intercurrent illness, concomitant medication, or extraneous causes with the exceptions defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.

  • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to approximately 24 months

    Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and electrocardiograms (ECGs) qualifying and reported as AEs.

  • Frequency of dose interruptions and reductionsUp to approximately 24 months

    Number of participants with dose interruptions and/or reductions to assess the tolerability.

  • Dose intensityUp to approximately 24 months

    Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.