PF-07248144 for Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer+2 MorePF-07248144 - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new drug to see if it's safe and effective. It will be given to people with breast cancer who have failed other treatments.

Eligible Conditions
  • Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
  • Non Small Cell Lung Cancer
  • Castration-resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 34 Secondary · Reporting Duration: Up to 24 months

Day 28
AUC from time zero to time of last measurable concentration (AUClast) in the participants in the food effect subset in monotherapy dose expansion arm
Maximum Observed Concentration (Cmax) in the participants in the food effect subset in monotherapy dose expansion arm
Time to Maximum concentration (Tmax) in the participants in the food effect subset in monotherapy dose expansion arm
Up to 24 months
Amount of PF-07248144 excreted in urine relative to dose administered (%) in a sub-set of participants in monotherapy dose expansion arm.
Upper arm
Upper arm
Duration of Respponse (DOR) in participants enrolled in the Dose Expansion Arms
Multiple Dose: Steady state AUC during a dosage interval (τ) (AUCτ,ss) in the Dose Escalation and Dose Finding Arms
Multiple Dose: Steady state AUC during a dosage interval (τ) (AUCτ,ss) in the Dose Esclation and Dose Finding Arms
Multiple Dose: Steady-State Cmax (Cmax,ss) in the Dose Escalation and Dose Finding Arms
Multiple Dose: Steady-State Cmax (Cmax,ss) in the Dose Esclation and Dose Finding Arms
Multiple Dose: Steady-state Cmin (Cmin,ss) in the Dose Escalation and Dose Finding Arms.
Multiple Dose: Steady-state Cmin (Cmin,ss) in the Dose Esclation and Dose Finding Arms.
Upper arm
Multiple Dose: Steady-state Tmax (Tmax,ss) in the Dose Esclation and Dose Finding Arms
Multiple Dose: Steady-state apparent total clearance (CLss/F) in the Dose Escalation and Dose Finding Arms.
Multiple Dose: Steady-state apparent total clearance (CLss/F) in the Dose Esclation and Dose Finding Arms.
Overall survival (OS) observed in particiapants enrolled in Dose Expansion Arms
Upper arm
Palbociclib trough concentrations at steady instate (Cmin,ss) in the 1C combination dose finding arm.
Peak concentrations of PF-07248144 for selected cycles in the Dose Expansion Arms
Progression Free Survival (PFS) observed in participants in the Dose Expansion Arms
Renal clearance (CLr) in a sub-set of participants in monotherapy dose expansion arm
Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Escalation Arms.
Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Esclation Arms.
Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Expansion Arms
Safety and Tolerability through monitoring of laboratory assessments for participants enroled in the Dose Expansion Arms
Safety and Tolerability through monitoring of laboratory assessments for participants enrolled in the Dose Escalation Arms.
Safety and Tolerability through monitoring of laboratory assessments for participants enrolled in the Dose Esclation Arms.
Upper arm
Single Dose: AUC from time zero to time of last measurable concentration (AUClast) in the Dose Esclation and Dose Finding Arms
Upper arm
Single Dose: Maximum Observed Concentration (Cmax) in the Dose Esclation and Dose Finding Arms
Single Dose: Time to Maximum concentration (Tmax) in the Dose Escalation and Dose Finding Arms
Single Dose: Time to Maximum concentration (Tmax) in the Dose Esclation and Dose Finding Arms
Single and Multiple Dose: Terminal Elimination half-life (t1/2) in the Dose Escalation and Dose Finding Arms
Upper arm
Time to Progression (TTP) observed in participants emrolled in the Dose Expansion Arms
Time to Progression (TTP) observed in participants enrolled in the Dose Expansion Arms
Trough concentrations of PF-07248144 for selected cycles in the Dose Expansion Arms
Up to 29 days
Upper arm
Number of participants with dose-limiting toxicities in the Dose Esclation Arms.

Trial Safety

Safety Progress

1 of 3

Trial Design

11 Treatment Groups

2B Combination Dose Expansion Arm
1 of 11
1C Combination Dose Finding Arm Level 1
1 of 11
1A Monotherapy Escalation Dose Level 5
1 of 11
1B Combination Dose Finding Arm Level 2
1 of 11
1A Monotherapy Escalation Dose Level 4
1 of 11
1B Combination Dose Finding Arm level 1
1 of 11
1A Monotherapy Escalation Dose Level 3
1 of 11
1A Monotherapy Escalation Dose Level 1
1 of 11
1A Monotherapy Escalation Dose Level 2
1 of 11
2A Monotherapy Dose Expansion Arm
1 of 11
1C Combination Dose FInding Arm Level 2
1 of 11

Experimental Treatment

108 Total Participants · 11 Treatment Groups

Primary Treatment: PF-07248144 · No Placebo Group · Phase 1

2B Combination Dose Expansion ArmExperimental Group · 2 Interventions: PF-07248144, Fulvestrant · Intervention Types: Drug, Drug
1C Combination Dose Finding Arm Level 1Experimental Group · 3 Interventions: Letrozole, PF-07248144, Palbociclib · Intervention Types: Drug, Drug, Drug
1A Monotherapy Escalation Dose Level 5
Drug
Experimental Group · 1 Intervention: PF-07248144 · Intervention Types: Drug
1B Combination Dose Finding Arm Level 2Experimental Group · 4 Interventions: Letrozole, PF-07248144, Fulvestrant, Palbociclib · Intervention Types: Drug, Drug, Drug, Drug
1A Monotherapy Escalation Dose Level 4
Drug
Experimental Group · 1 Intervention: PF-07248144 · Intervention Types: Drug
1B Combination Dose Finding Arm level 1Experimental Group · 2 Interventions: PF-07248144, Fulvestrant · Intervention Types: Drug, Drug
1A Monotherapy Escalation Dose Level 3
Drug
Experimental Group · 1 Intervention: PF-07248144 · Intervention Types: Drug
1A Monotherapy Escalation Dose Level 1
Drug
Experimental Group · 1 Intervention: PF-07248144 · Intervention Types: Drug
1A Monotherapy Escalation Dose Level 2
Drug
Experimental Group · 1 Intervention: PF-07248144 · Intervention Types: Drug
2A Monotherapy Dose Expansion Arm
Drug
Experimental Group · 1 Intervention: PF-07248144 · Intervention Types: Drug
1C Combination Dose FInding Arm Level 2Experimental Group · 4 Interventions: Letrozole, PF-07248144, Fulvestrant, Palbociclib · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved
Fulvestrant
FDA approved
Palbociclib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

PfizerLead Sponsor
4,310 Previous Clinical Trials
7,111,510 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,281 Previous Clinical Trials
4,820,781 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female and have advanced or metastatic breast cancer of nonchildbearing potential.
You have locally advanced or metastatic breast cancer, CRPC, or NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available.
You have HER2-positive advanced or metastatic breast cancer
Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of HER2-negative tumor.
You must have at least 1 measurable lesion as defined by RECIST version 1.