NCT04553133

PF-07104091 as a Single Agent and in Combination Therapy

PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.

Detailed description

Study C4161001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-07104091 in adult patients with advanced or metastatic small cell lung cancer (SCLC), advanced platinum resistant epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer, locally recurrent/advanced or metastatic triple negative breast cancer (TNBC), HR-positive HER2-negative advanced or mBC, advanced or metastatic non-small cell lung cancer (NSCLC). This two part study will assess the safety and tolerability of increasing dose levels of PF-07104091 in Part 1, and establish the recommended Phase 2 dose (RP2D) in Part 2.

Conditions

• Small Cell Lung Cancer
• Ovarian Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	PF-07104091 monotherapy dose escalation	PF-07104091 will be administered orally
DRUG	PF-07104091 + palbociclib + fulvestrant	PF-07104091 will be administered orally in combination with palbociclib and fulvestrant
DRUG	PF-07104091 + palbociclib + letrozole	PF-07104091 will be administered orally in combination with palbociclib and letrozole
DRUG	PF-07104091 monotherapy dose expansion (ovarian)	PF-07104091 will be administered orally
DRUG	PF-07104091 monotherapy dose expansion (SCLC)	PF-07104091 will be administered orally
DRUG	PF-07104091 + Fulvestrant (post CDK4/6)	PF-07104091 will be administered orally in combination with fulvestrant
DRUG	PF-0704091 + Fulvestrant (post CDK4/6)	PF-07104091 + fulvestrant (post 4/6) dose expansion

Timeline

• Start date: 2020-09-16
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-09-17
• Last updated: 2026-04-13

Locations

46 sites across 5 countries: United States, Argentina, Bulgaria, China, Japan

Regulatory

• FDA-regulated drug study