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...
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GVV858 is an investigational small molecule being studied for the treatment of advanced HR+/HER2- breast cancer. It is also being evaluated in advanced CCNE1-amplified solid tumors and metastatic castration-resistant prostate cancer. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GVV858 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting a Phase 1 clinical trial of GVV858 as a single agent or in combination with endocrine therapy for patients with HR+/HER2- breast cancer and other advanced solid tumors.
GVV858 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The ongoing Phase 1 trial is actively recruiting participants and is designed to evaluate the safety and preliminary efficacy of GVV858 in patients with advanced HR+/HER2- breast cancer and other solid tumors.
GVV858 is being studied in a single Phase 1 clinical trial with the identifier NCT07288359. This trial is recruiting 205 participants across multiple countries, including the United States, Japan, and several European nations. The study evaluates GVV858 as a monotherapy or in combination with endocrine therapy in patients with advanced HR+/HER2- breast cancer, CCNE1-amplified solid tumors, and metastatic castration-resistant prostate cancer.
Yes, GVV858 is being studied both as a single agent and in combination with endocrine therapy. The Phase 1 clinical trial NCT07288359 is designed to assess the safety and tolerability of GVV858 when used alone or together with endocrine therapy in patients with advanced HR+/HER2- breast cancer and other advanced solid tumors.
The Phase 1 trial of GVV858 (NCT07288359) is a randomized, controlled study with a planned enrollment of 205 participants. It is not double-blinded. The trial is open to adults aged 18 years and older of all sexes, and it is currently recruiting in the United States, Czechia, Denmark, France, Germany, Italy, Japan, Singapore, Spain, and Taiwan.