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Zovegalisib · 1 trial · 6 indications
| Arm | Type | Description |
|---|---|---|
| Zovegalisib + fulvestrant | EXPERIMENTAL | Zovegalisib + fulvestrant combination for participants with HR+/HER2- advanced breast cancer |
| capivasertib + fulvestrant | ACTIVE_COMPARATOR | capivasertib + fulvestrant combination for participants with HR+/HER2- advanced breast cancer |
| Name | Type | Description |
|---|---|---|
| Zovegalisib | DRUG | 400 mg orally BID administered daily on a 28-day treatment cycle |
| Capivasertib | DRUG | 400mg orally BID administered on an intermittent weekly dosing schedule. Patients will dose on Days 1 through 4 each week of a 28-day treatment cycle |
| Fulvestrant | DRUG | 500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle) |
Inclusion Criteria: * Patient has ECOG performance status of 0-1 * One or more known primary oncogenic PIK3CA mutation(s) * Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing ...
Zovegalisib is an investigational small molecule being developed for the treatment of PIK3CA-mutant HR+/HER2- breast cancer. It is currently in a Phase 3 clinical trial for patients with locally advanced or metastatic breast cancer that is hormone receptor positive and HER2 negative.
Zovegalisib targets the PIK3CA mutation, a genetic alteration commonly found in certain cancers. The drug is designed to treat cancers that harbor this specific mutation, particularly in hormone receptor positive, HER2 negative breast cancer.
Zovegalisib is being developed by Relay Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol RLAY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating PIK3CA-mutant breast cancer.
Zovegalisib is currently in Phase 3 clinical development. It has received Breakthrough Therapy designation from the FDA, which is granted to expedite the development and review of drugs that may demonstrate substantial improvement over existing therapies for serious conditions.
Zovegalisib is being studied in a Phase 3 clinical trial with the identifier NCT06982521. This randomized, active-controlled study compares Zovegalisib plus fulvestrant to capivasertib plus fulvestrant in patients with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer. The trial is currently recruiting participants.
Yes, Zovegalisib is also known as RLY-2608. The Phase 3 clinical trial NCT06982521 refers to the drug as RLY-2608, and it is being evaluated in combination with fulvestrant for the treatment of PIK3CA-mutant breast cancer.