NCT04606446

Study of PF-07248144 in Advanced or Metastatic Solid Tumors

A PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07248144 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with other agents

Detailed description

Study has two parts, Part 1 (dose escalation) and Part 2 (dose expansion). Part 1 is divided into Parts 1A, 1B, 1C, 1D and 1E and Part 2 is divided into Parts 2A, 2B, 2D and 2E. In Part 1A, single escalating doses of PF-07248144 alone will be administered to determine the maximum tolerable dose (MTD) and select the recommended dose for expansion (RDE). In Part 1B, 1C, 1D and 1E PF-07248144 will be administered in combination with either fulvestrant (Part 1B); palbociclib + letrozole (Part 1C) or PF-07220060+fulvestrant (Part 1D) or vepdegestrant (Part 1E). After the determination of the monotherapy RDE in Part 1A, PF-07248144 will be evaluated in a dose expansion cohort as a monotherapy in Part 2A. After determination of the combination RDE from Part 1B, PF-07248144 in combination with fulvestrant, PF-07248144 will be evaluated in a combination dose expansion with fulvestrant in Part 2B. In Part 1C, PF-07248144 in combination with letrozole + palbociclib will be evaluated for dose finding to determine the MTD and RDE for this combination. After determination of the triple combination RDE from Part 1D, PF-07248144 in combination with PF-07220060 + fulvestrant will be evaluated in a combination dose-expansion cohort, Part 2D. After determination of the combination RDE from Part 1E, PF-07248144 in combination with vepdegestrant will be evaluated in a combination dose-expansion cohort, Part 2E.

Conditions

• Locally Advanced or Metastatic ER+ HER2- Breast Cancer
• Locally Advanced or Metastatic Castration-resistant Prostate Cancer
• Locally Advanced or Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	PF-07248144	KAT6 Inhibitor
DRUG	Fulvestrant	Endocrine Therapy
DRUG	Letrozole	Endocrine Therapy
DRUG	Palbociclib	CDK4/6 Inhibitor
DRUG	PF-07220060	CDK4 inhibitor
DRUG	PF-07850327, ARV-471, vepdegestrant	PROTAC (PROteolysis Targeting Chimera) ER degrader

Timeline

• Start date: 2020-11-16
• Primary completion: 2029-07-13
• Completion: 2029-08-10
• First posted: 2020-10-28
• Last updated: 2026-04-16

Locations

44 sites across 5 countries: United States, Australia, China, Japan, South Korea

Regulatory

• FDA-regulated drug study