PF-07260437 for Ovarian Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ovarian Tumors+2 MorePF-07260437 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment targeting B7-H4 expressing tumors. The safety and effectiveness of the treatment will be evaluated in adults with advanced breast, ovarian, or endometrial cancer.

Eligible Conditions
  • Ovarian Tumors
  • Breast Cancer
  • Endometrial Cancer

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 23 Secondary · Reporting Duration: Baseline through 2 years

Day 28
Neoplasms
Baseline through 2 years
Number of participants with clinically significant laboratory abnormalities
Number of participants with clinically significant laboratory abnormalities at recommended dose for expansion
Day 28
Number of participants with dose limiting toxicities (DLTs) in Dose escalation
Baseline through 90 days
Number of participants with immune related adverse events
Year 2
Number of participants with adverse events
Number of participants with clinical adverse events at the recommended dose for expansion
Number of participants with immune related adverse events at the recommended dose for expansion
Overall survival (OS) in the Expansion Cohorts (Part 2)
Year 2
Duration of response (DOR) in dose expansion
Objective response rate (ORR) in dose expansion
Progression free survival (PFS)
Time to progression (TTP) in dose expansion
Year 2
Apparent Volume of Distribution (Vz/F)
Year 2
Accumulation Ratio (Rac)
Year 2
Minimum Observed Plasma Trough Concentration at Steady State (Cmin,ss)
Year 2
Time to reach maximum Observed Plasma Concentration at Steady State (Tmax,ss)
Year 2
Apparent Oral Clearance (CL/F)
Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)
Area under the curve at steady state under a dosing interval (AUCss,τ)
Incident and titers of anti-body drug antibody against PF-07260437
Incident and titers of anti-body neutralizing antibody against PF-07260437
Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
Plasma Decay Half-live (t1/2)
Single dose: Area Under the Curve (AUClast)
Single dose: Maximal concentration (Cmax)
Time to maximal plasma concentration (Tmax)
Year 2
Apparent Oral Clearance of Study Drug (CLss/F)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Monotherapy dose escalation (Part 1)
1 of 4
Dose Expansion (Part 2B) - Tumor specific Arm B
1 of 4
Dose Expansion (Part 2A) - Tumor specific Arm A
1 of 4
Dose Expansion (Part 2C) - Tumor specific Arm C
1 of 4

Experimental Treatment

100 Total Participants · 4 Treatment Groups

Primary Treatment: PF-07260437 · No Placebo Group · Phase 1

Monotherapy dose escalation (Part 1)
Drug
Experimental Group · 1 Intervention: PF-07260437 · Intervention Types: Drug
Dose Expansion (Part 2B) - Tumor specific Arm BExperimental Group · 2 Interventions: B7-H4 IHC, PF-07260437 · Intervention Types: DiagnosticTest, Drug
Dose Expansion (Part 2A) - Tumor specific Arm AExperimental Group · 2 Interventions: B7-H4 IHC, PF-07260437 · Intervention Types: DiagnosticTest, Drug
Dose Expansion (Part 2C) - Tumor specific Arm CExperimental Group · 2 Interventions: B7-H4 IHC, PF-07260437 · Intervention Types: DiagnosticTest, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through 2 years

Who is running the clinical trial?

PfizerLead Sponsor
4,310 Previous Clinical Trials
7,111,524 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,281 Previous Clinical Trials
4,820,795 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histological diagnosis of locally advanced or metastatic triple negative breast cancer with high B7-H4 expression.
You have histological/cytological diagnosis of breast cancer, endometrial cancer or ovarian cancer.

Who else is applying?

How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%