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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests INR731, a medicine taken by mouth, alone or with standard medicines that block male hormone signals. It is for adults with prostate cancer that has spread to other parts of the body. Researchers will check safety, side effects, how the drug works in the body, whether it fights cancer, and what dose to use.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be able to care for yourself and be out of bed or a chair for at least half of your waking hours (ECOG score of 0–2).
  • Lab tests must confirm prostate adenocarcinoma, a cancer that starts in gland cells. Mixed cancer types are allowed if most of the cancer is adenocarcinoma.
  • A CT, MRI, or bone scan must show at least one spot where cancer has spread. The scan must be done within 28 days before treatment starts.
  • Your testosterone level must be very low: below 50 ng/dL or 1.7 nmol/L.
  • Treatment to lower testosterone is allowed, including surgery to remove the testicles or ongoing hormone-lowering medicines.
  • Your cancer must have spread and grown despite very low testosterone. It must have worsened on other standard treatments, or those treatments must not be an option for you.
  • Past treatment with taxane chemotherapy, PARP inhibitors, or Pluvicto is allowed.
  • For the combination expansion group, you must not have had treatment for cancer that has spread and grows despite very low testosterone. Earlier treatment while the cancer still responded to hormone-lowering therapy is allowed.

Who can't join

  • You are younger than 18.
  • Tests show a prostate cancer type other than adenocarcinoma, except for the mixed types allowed above.
  • Only blood tests suggest the cancer has returned, or scans do not show that it has spread.
  • You have taken a cereblon-based degrader, a type of drug that breaks down certain proteins.
  • You have HIV or a weakened immune system.
  • You take medicines that can cause a heart rhythm change called QT prolongation and cannot stop them for the whole study.
  • You received an experimental drug too recently before the planned first dose: within 7 days, or within five drug half-lives, whichever is longer. A half-life is the time it takes the body to clear half of a drug.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

MA

TX