Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GVV858 · 1 trial · 3 indications
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...
Top 20 of 87 competitors
GVV858 is an investigational small molecule developed by Novartis AG for advanced HR+/HER2- breast cancer and other advanced solid tumors. It is being studied as a single agent and in combination with endocrine therapy. GVV858 is in Phase 1 clinical development and has not been approved by the FDA.
GVV858 is being evaluated for the treatment of advanced HR+/HER2- breast cancer, a form of breast cancer that is hormone receptor positive and HER2 negative. The Phase 1 study also enrolls patients with CCNE1-amplified solid tumors and metastatic castration-resistant prostate cancer.
GVV858 is being developed by Novartis AG, which trades under the ticker NVS. Novartis is sponsoring the Phase 1 clinical program evaluating GVV858 as a single agent and in combination with endocrine therapy in patients with advanced HR+/HER2- breast cancer and other advanced solid tumors.
GVV858 is in Phase 1 clinical development. It is an investigational therapy and is not FDA approved. The ongoing Phase 1 trial is currently recruiting participants and is designed to evaluate GVV858 as a single agent or in combination with endocrine therapy.
GVV858 is being studied in one active Phase 1 trial, NCT07288359, titled a 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. The trial is recruiting and plans to enroll 205 participants across multiple countries.
Yes, the GVV858 Phase 1 trial NCT07288359 enrolls a biomarker-selected population. It includes patients with advanced HR+/HER2- breast cancer as well as patients with CCNE1-amplified solid tumors, indicating that biomarker status is part of the study design for certain cohorts.