Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gedatolisib · 4 trials · 8 indications
PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)
Type, incidence, severity (as graded by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0), seriousness, and relationship to study medications of adverse events (AEs) and any laboratory abnormalities
Incidence of dose-limiting toxicities (DLTs) and AEs graded according to NCI CTCAE v5.0
Radiographic progression-free survival rate at 6 months as measured by the Kaplan-Meier (K-M) method and assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria
Determine the recommended Phase 2 dose (RP2D) of talazoparib in combination with gedatolisib in patients with advanced human epidermal growth factor receptor 2 (HER2) negative (triple negative or BRCA1/2 deficient) breast cancer.
Calculate ORR, which will include confirmed complete response (CR) + confirmed partial response (PR) determined as per RECIST1.1 on treatment with talazoparib in combination with gedatolisib in patients with BRCA1/2 deficient advanced HER2 negative breast cancer.
Number of patients for each response category, objective response rate (number of patients with a complete response (CR)) relative to the number of response evaluable patients
| Arm | Type | Description |
|---|---|---|
| Arm A - Patients Lacking PIK3CA Mutations (WT) | EXPERIMENTAL | Gedatolisib + Palbociclib + Fulvestrant |
| Arm B - Patients Lacking PIK3CA Mutations (WT) | EXPERIMENTAL | Gedatolisib + Fulvestrant |
| Arm C - Patients Lacking PIK3CA Mutations (WT) | ACTIVE_COMPARATOR | Fulvestrant |
| Arm D - Patients with PIK3CA Mutation (MT) | EXPERIMENTAL | Gedatolisib + Palbociclib + Fulvestrant |
| Arm E - Patients with PIK3CA Mutation (MT) | ACTIVE_COMPARATOR | Alpelisib + Fulvestrant |
| Arm F - Patients with PIK3CA Mutation (MT) | EXPERIMENTAL | Gedatolisib + Fulvestrant |
| Phase 1 Arm 1 | EXPERIMENTAL | Arm 1 - 120 mg of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle) |
| Phase 1 Arm 2 | EXPERIMENTAL | Arm 2 - 180 mg of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle) |
| Phase 2 | EXPERIMENTAL | The recommended Phase 2 dose (RP2D) of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle) |
| Talazoparib + Gedatolisib | EXPERIMENTAL | Talazoparib + Gedatolisib Phase 1: Dose Level -1: Gedatolisib 150mg IV, Days 1,8,15,22; Talazoparib 0.75 mg/orally qd, Days 1-28 Dose Level 1: Gedatolisib 180mg IV, Days 1,8,15,22; Talazoparib 0.75 mg/orally qd, Days 1-28 Dose Level 2: Gedatolisib 180mg IV, Days 1,8,15,22; Talazoparib 1.00 mg/orally qd, Days 1-28 Phase 2: Gedatolisib 180 mg IV on days 1, 8, 15 and 22; Talazoparib 1.00 mg once daily, Days 1-28. Subjects receiving weekly gedatolisib may continue current regimen or may switch to gedatolisib 180 mg IV on days 1, 8, and 15; Talazoparib 1.00 mg once daily, Days 1-28 (3 weeks on/ 1 week off). All changes will be permanent. |
| Letrozole Cohort | EXPERIMENTAL | Letrozole combination cohort in dose escalation |
| Fulvestrant cohort | EXPERIMENTAL | Fulvestrant combination cohort in dose escalation |
| ARM A | EXPERIMENTAL | Gedatolisib + palbociclib + letrozole in dose expansion |
| ARM B | EXPERIMENTAL | Gedatolisib + palbociclib + fulvestrant in dose expansion |
| ARM C | EXPERIMENTAL | Gedatolisib + palbociclib + fulvestrant in dose expansion |
| Arm D | EXPERIMENTAL | Gedatolisib (3:1) + palbociclib + fulvestrant in dose expansion |
| Name | Type | Description |
|---|---|---|
| Gedatolisib | DRUG | Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off |
| Palbociclib | DRUG | Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off |
| Fulvestrant | DRUG | Fulvestrant 500 mg IM (2 × 5 mL injections) given every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 |
| Alpelisib | DRUG | Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days) |
| Darolutamide | DRUG | Darolutamide is a novel androgen receptor inhibitor that has been studied and received approval for treatment of patients with nonmetastatic CRPC and in metastatic hormone-sensitive prostate cancer. |
| Talazoparib | DRUG | .75-1.00mg |
| Letrozole | DRUG | Letrozole at 2.5 mg daily |
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients ...
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Gedatolisib is an investigational small molecule being studied for the treatment of breast cancer, including HR+/HER2- advanced or metastatic breast cancer, and triple-negative breast cancer (TNBC). It is also being evaluated in metastatic castration-resistant prostate cancer (mCRPC). It is not yet approved and remains in clinical development.
Gedatolisib is a pan-PI3K/mTOR inhibitor that targets the class I PI3K isoforms PIK3CA, PIK3CB, PIK3CD, PIK3CG, and the regulatory subunits PIK3R1 and PIK3R2. By inhibiting these targets, it is designed to block the PI3K signaling pathway involved in tumor growth.
Gedatolisib is being developed by Celcuity Inc. (NASDAQ: CELC). The company is conducting clinical trials to evaluate the drug in combination with other agents for the treatment of breast cancer and prostate cancer.
Gedatolisib is in Phase 3 clinical development. The Phase 3 VIKTORIA-1 trial (NCT05501886) is evaluating gedatolisib plus fulvestrant with or without palbociclib versus standard-of-care in patients with advanced or metastatic HR+/HER2- breast cancer.
Gedatolisib is being studied in multiple trials, including the Phase 3 VIKTORIA-1 trial (NCT05501886) in HR+/HER2- breast cancer, a Phase 1 trial (NCT03911973) in TNBC, a Phase 1 trial (NCT06190899) in mCRPC, and a completed Phase 1 trial (NCT02684032) in metastatic breast cancer.
Gedatolisib is the investigational drug being tested in combination regimens referred to as Arm A (gedatolisib plus palbociclib plus fulvestrant) and Arm C (gedatolisib plus palbociclib plus letrozole) in clinical trials. These are treatment arms within studies, not alternative names for the drug itself.