*A Phase 1 study of PF-07220060 in Participants with Advanced Solid Tumors
Research type
Research Study
Full title
A PHASE 1/1B STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMORACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
IRAS ID
1003898
Contact name
Samantha Grant
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2020-002938-33
Research summary
This is a Phase 1, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics study of PF-07220060 administered sequentially as a single agent and then in combination with endocrine therapy.
In Part 1A, single escalating doses of PF-07220060 will be administered beginning at 100 mg BID dose on a continuous basis to determine the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 Dose (RP2D) of PF-07220060 as monotherapy. In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole or fulvestrant, respectively) to identify the MTD and/or select the RP2D of PF-07220060 with each endocrine agent. The starting dose of PF-0720060 in Part 1B and Part 1C will not be higher than the highest dose determined to be safe in Part 1A.
Part 1D will enroll approximately 6 patients to assess the effect of food on PK of PF-07220060 at the monotherapy RP2D.
Part 2B is an expansion cohort for combination therapy of PF-07220060 with letrozole in patients with HR-positive/HER2-negative advanced/metastatic breast cancer who have not received any prior systemic anti-cancer therapies for their advanced disease. Part 2C is an expansion cohort for combination therapy of PF-07220060 with fulvestrant (with or without goserelin) in patients with HR-positive/HER2-negative advanced/metastatic breast cancer whose disease has progressed on prior therapy.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0145
Date of REC Opinion
8 Oct 2021
REC opinion
Further Information Favourable Opinion