NCT04557449

Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy. The study consists of two parts and a China and Japan monotherapy cohort. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from the Part 1A will be conducted In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI) In Part 1F, escalating dosed of PF-07220060 will be administered in combination with enzalutamide Part 1B and Part 1C may commence at MTD or before reaching the MTD at a dose level in Part 1A. Part 2A is a dose expansion cohort with fulvestrant and will explore more than one dose of PF-07220060 in participants diagnosed with mBC. Part 2B and Part 2C are expansion for combination therapy of PF-07220060 with letrozole and fulvestrant, respectively. Part 2D is the expansion cohort for combination therapy of PF-07220060 with enzalutamide. Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. The China monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as single agent in Chinese participants. The Japan monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as a single agent in Japanese participants.

Conditions

• Liposarcoma
• Prostate Cancer
• Breast Neoplasms
• Adenocarcinoma of Lung

Interventions

Type	Name	Description
DRUG	PF-07220060	CDK4 inhibitor
COMBINATION_PRODUCT	Letrozole	Endocrine Therapy
COMBINATION_PRODUCT	Fulvestrant	Endocrine Therapy
DRUG	Midazolam	Benzodiazepine used for DDI
COMBINATION_PRODUCT	Enzalutamide	Androgen Receptor inhibitor

Timeline

• Start date: 2020-09-23
• Primary completion: 2026-09-23
• Completion: 2027-11-23
• First posted: 2020-09-21
• Last updated: 2025-10-01

Locations

38 sites across 8 countries: United States, Argentina, China, Czechia, Japan, Mexico, Slovakia, United Kingdom

Regulatory

• FDA-regulated drug study