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 small molecule being developed for metastatic castration-resistant prostate cancer (mCRPC). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied as a single agent and in combination with an androgen receptor pathway inhibitor.
INR731 is being developed by Novartis AG (NVS), a global pharmaceutical company. The drug is currently in Phase 1 clinical trials for metastatic castration-resistant prostate cancer. Novartis is conducting the clinical development program to evaluate the safety and tolerability of this investigational therapy.
INR731 is in Phase 1 clinical development. It is an investigational drug being studied for metastatic castration-resistant prostate cancer (mCRPC). The drug has not been approved by the FDA or other regulatory agencies and remains in early-stage clinical testing to evaluate its safety and tolerability.
INR731 is being studied in a Phase 1 clinical trial (NCT07570979) that is currently recruiting participants. The trial is investigating oral INR731 as a single agent or in combination with an androgen receptor pathway inhibitor in patients with metastatic prostate cancer. The study is enrolling approximately 208 male participants aged 18 years and older.
INR731 is administered orally. The Phase 1 clinical trial NCT07570979 is investigating oral INR731 as a single agent or in combination with an androgen receptor pathway inhibitor in patients with metastatic prostate cancer. The study is being conducted in the United States, Australia, and Japan.