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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07570966 | Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors | PHASE1 | NOT YET_RECRUITING | 217 | — | — | Jun 30, 2026 | Aug 1, 2031 | May 6, 2026 | - | — |
Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3, unless clearly and inconvertibly assessed as due to disease progression, inter-current illness/injury, concomitant medications, or extraneous causes, that occurs within the first 28 days of treatment in the Phase I part. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Number of participants with dose adjustments (interruptions, reductions, or permanent discontinuation) as a measure of tolerability.
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
| Arm | Type | Description |
|---|---|---|
| Phase I: ERW316 single agent (Arm A) | EXPERIMENTAL | ERW316 |
| Phase I: ERW316 in combination with Fulvestrant (Arm B) | EXPERIMENTAL | ERW316 in combination with fulvestrant. |
| Phase I: ERW316 in combination with letrozole (Arm C) | EXPERIMENTAL | ERW316 in combination with letrozole. |
| Phase II, recommended dose (RD)-1: ERW316 in combination with Fulvestrant (Arm D) | EXPERIMENTAL | ERW316 in combination with fulvestrant. |
| Phase II, RD-2 (optional dose optimization): ERW316 in combination with Fulvestrant (Arm E) | EXPERIMENTAL | ERW316 in combination with fulvestrant. |
| Name | Type | Description |
|---|---|---|
| ERW316 | DRUG | Oral administration |
| Fulvestrant | DRUG | Intramuscular injection. Approved medication. |
| Letrozole | DRUG | Oral administration. Approved medication. |
Inclusion Criteria: * Age ≥ 18 years old * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. * Patients with one of the following histologically or cytologically confirmed advanced cancers: Phase I (patients with one of the following cancers, for whom no standard therapy is avai...