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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07288359 | Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors | PHASE1 | RECRUITING | 205 | — | — | Dec 29, 2025 | May 9, 2031 | Jun 4, 2026 | 9 | United States, Denmark +6 |
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 or higher, 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 1 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 vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) as a measure of tolerability.
The dose intensity of each study drug is computed as the ratio of actual cumulative dose received and actual duration of exposure.
| Arm | Type | Description |
|---|---|---|
| GVV858 Single Agent (Arm A) | EXPERIMENTAL | Phase I |
| GVV858 in combination with fulvestrant (Arm B) | EXPERIMENTAL | Phase I |
| GVV858 in combination with letrozole (Arm C) | EXPERIMENTAL | Phase I |
| GVV858 in combination with fulvestrant (Arm D) | EXPERIMENTAL | Phase II, recommended dose regimen 1 |
| GVV858 in combination with fulvestrant (Arm E) | EXPERIMENTAL | Phase II, recommended dose regimen 2, optional dose optimization |
| Name | Type | Description |
|---|---|---|
| GVV858 | DRUG | Experimental |
| Fulvestrant | DRUG | Approved medication |
| Letrozole | DRUG | Approved medication |
Inclusion Criteria: * Age ≥ 18 years old. * Patients with one of the following histologically or cytologically confirmed advanced cancers: Phase I (patients with one of the following cancers, from whom no standard therapy is available or appropriate in the judgment of the investigator): * HR+/HER...