Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE1 | RECRUITING | 208 | — | — | May 25, 2026 | Jun 3, 2030 | May 28, 2026 | 2 | United States, Australia |
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...