New prostate cancer drug enters first human trials
NCT ID NCT07570979
First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This early-stage trial tests a new oral drug called INR731, alone or with standard hormone therapy drugs, in 208 men with metastatic prostate cancer that no longer responds to hormone treatment. The main goals are to check safety, find the right dose, and see if the drug shows any signs of shrinking tumors. Participants must have advanced cancer that has spread and meet specific health criteria.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- INR731 (oral drug)
- What this could lead to
- If successful, this could point toward a new treatment option for metastatic prostate cancer that is resistant to hormone therapy.
- What could go wrong
- This is an early Phase 1 trial with only 208 participants, so the drug may not prove effective or may have significant side effects. It is too early to know if it will work.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 208 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mary Crowley Cancer Research
RECRUITINGDallas, Texas, 75251, United States
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Novartis Investigative Site
RECRUITINGMelbourne, Victoria, 3000, Australia
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Novartis Investigative Site
RECRUITINGMontreal, Quebec, H2X 1R9, Canada
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Novartis Investigative Site
RECRUITINGHirakata, Osaka, 5731191, Japan
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Novartis Investigative Site
RECRUITINGSeoul, 03722, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Training a Patient's own immune cells to fight advanced prostate cancer
- Radioactive missile aims at prostate cancer that spread
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Can a Cancer-Targeting drug slow advanced prostate cancer?