Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INR731 · 1 trial · 1 indication
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 AEs and SAEs, including changes in laboratory values, vital signs and electrocardiograms (ECGs) qualifying and reported as AEs.
Number of participants with dose interruptions and/or reductions to assess the tolerability.
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
| Arm | Type | Description |
|---|---|---|
| INR731 single agent (Arm A) | EXPERIMENTAL | The dose escalation part with single agent INR731 may be followed by a dose expansion part. |
| INR731 in combination with enzalutamide (Arm B) | EXPERIMENTAL | The dose escalation part with INR731 in combination with enzalutamide may be followed by a dose expansion part. |
| INR731 in combination with abiraterone (Arm C) | EXPERIMENTAL | Dose escalation of INR731 in combination with abiraterone. |
| Name | Type | Description |
|---|---|---|
| INR731 | DRUG | Oral administration |
| Enzalutamide | DRUG | Oral administration |
| Abiraterone | DRUG | Oral administration |
| Androgen deprivation therapy (ADT) | DRUG | Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care. |
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 f...
INR731 is an investigational oral small molecule being developed by Novartis AG for metastatic castration-resistant prostate cancer (mCRPC). It is in Phase 1 clinical development and is being studied both as a single agent and in combination with an androgen receptor pathway inhibitor (ARPI). It has not been approved by the FDA.
INR731 is being studied for the treatment of metastatic castration-resistant prostate cancer (mCRPC), an advanced form of prostate cancer that has spread and no longer responds to standard androgen deprivation therapy. It is investigational and has not been approved for any indication.
INR731 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the ongoing Phase 1 clinical trial evaluating the drug in metastatic prostate cancer.
INR731 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The single ongoing trial is a Phase 1 study evaluating safety and tolerability in patients with metastatic prostate cancer.
INR731 is being evaluated in one active clinical trial, NCT07570979, titled "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." The trial is recruiting, with an estimated enrollment of 208 male participants aged 18 years and older across the United States, Australia, Canada, Germany, Japan, and South Korea.