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Phase 1b Study To Assess The Safety, Tolerability, and Clinical Activity of Gedatolisib in Combination with Palbociclib and Either Letrozole Or Fulvestrant in Women with Metastatic or Locally Advanced/Recurrent Breast Cancer (Mbc)
The purpose of this research study is to learn about the effects of the study drug, gedatolisib, when given in combination with the typical dose of other drugs to treat breast cancer and to find the best dose of gedatolisib in combination with these drugs. The study is made up of two parts. In the first part (called the dose escalation phase), participants will be treated with different dose levels of gedatolisib in combination with palbociclib/letrozole or palbociclib/fulvestrant. This is done in order to determine the maximum tolerated dose or MTD of gedatolisib that will be used in the second part of the study. In the second part (called the dose expansion phase), there will be three groups (arms) of participants: Arm A: Gedatolisib in combination with palbociclib/letrozole (for participants who have not received any endocrine-based therapy). Arm B: Gedatolisib in combination with palbociclib/fulvestrant (for participants who have not been previously treated with palbociclib). Arm C: Gedatolisib in combination with palbociclib/fulvestrant (for participants who have been previously treated with palbociclib). Which group participants are assigned to will depend on their cancer history and what treatments they have already received.
Primary Objective Dose Escalation: To assess the safety, tolerability, and MTD of the triplet combination of gedatolisib added to either the standard dose of the palbociclib/letrozole or palbociclib/fulvestrant. Dose Expansion: To determine if the triplet combination of gedatolisib plus palbociclib/letrozole or gedatolisib plus palbociclib/fulvestrant produces a superior objective response (OR) in patients with mBC, compared to historical control data of the doublet combination of palbociclib plus either letrozole or fulvestrant. Secondary Objectives: To further assess the safety and tolerability of the combinations tested in the study. To assess anti-tumor activity in the dose escalation portion. To assess additional efficacy parameters in the expansion portion, including duration of response (DR) and progression free survival (PFS). To characterize the potential for prolonged QTc interval. To assess the single dose and multiple dose pharmacokinetics (PK) of gedatolisib and palbociclib, and the multiple dose pharmacokinetics of fulvestrant and letrozole.