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

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

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).

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-15

Primary Completion

2026-04-14

Completion

2028-04-13

FDA Drug

Yes