NCT05905341

Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.

A PHASE 1, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07224826, AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07224826, as a single agent or in combination with endocrine therapy in participants with advanced solid tumors. This study will be divided into dose escalation/finding (Part 1) and dose expansion (Part 2). In Part 1, participants with locally recurrent/advanced or metastatic Triple Negative Breast Cancer (TNBC), platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. In Part 2 (Arm A), PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative advanced or mBC participants who have received prior CDK4/6 inhibitor. In Part 2 (Arm B), PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative locally advanced or mBC participants whose disease has progressed on prior endocrine therapy and is naïve to CDK4/6 inhibitors.

Conditions

• Breast Cancer
• Ovarian Cancer
• Liposarcoma
• Non-small Cell Lung Cancer (NSCLC)
• Endometrial
• Solid Tumors

Interventions

Type	Name	Description
DRUG	PF-07224826	Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
COMBINATION_PRODUCT	Fulvestrant	Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
DRUG	PF-07224826	Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
COMBINATION_PRODUCT	Fulvestrant	Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
DRUG	PF-07224826	Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
COMBINATION_PRODUCT	Fulvestrant	Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
DRUG	PF-07224826	Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
COMBINATION_PRODUCT	Fulvestrant	Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
DRUG	PF-07224826	Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
COMBINATION_PRODUCT	Fulvestrant	Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
DRUG	PF-07224826	Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
COMBINATION_PRODUCT	Fulvestrant	Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
DRUG	PF-07224826	Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
COMBINATION_PRODUCT	Fulvestrant	Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).

Timeline

• Start date: 2024-01-15
• Primary completion: 2026-04-14
• Completion: 2028-04-13
• First posted: 2023-06-15
• Last updated: 2023-11-08

Regulatory

• FDA-regulated drug study