An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Pfizer
Study ID
NCT07426757
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Cancer
  • Advanced Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-07994525 — DRUG
    Oral administration
  • Midazolam — DRUG
    Oral administration

Study Details

This is an open-label, dose escalation and dose expansion study evaluating the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and antitumor activity of PF-07994525 in participants with R/R MM. The study will consist of 2 parts: Part 1 (Dose Escalation) will consist of PF-07994525 dose escalation to assess the safety, tolerability, and preliminary antitumor activity in participants with R/R MM. In Part 2 (Dose expansion), PF-07994525 may be evaluated in additional participants with R/R MM to further assess safety, PK, PD, and preliminary anti-tumor activity.

Key Dates

First listed
Feb 23, 2026
Start date
Jul 1, 2026
Status verified
Aug 2026
Primary completion
Jul 10, 2029
Completion
Jul 10, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    Monotherapy Dose Expansion
  • Experimental: Part 2
    Monotherapy Dose Escalation

Primary Outcome Measure

Type, incidence and severity of participants with adverse events (AEs) [ Time Frame: From the first day through 30-37 days after the last study treatment, up to approximately 2 years ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical CenterCoral GablesFlorida33146-
Sylvester Comprehensive Cancer Center - Coral SpringsCoral SpringsFlorida33065-
University of Miami Hospital and Clinics - Deerfield BeachDeerfield BeachFlorida33442-
University of Miami Hospital and Clinics - DoralDoralFlorida33166-
Sylvester Comprehensive Cancer Center - HollywoodHollywoodFlorida33021-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Sylvester Comprehensive Cancer Center- KendallMiamiFlorida33176-
University of Miami Hospital and ClinicsMiamiFlorida33136-
Sylvester Comprehensive Cancer Center - Sole MiaNorth MiamiFlorida33181-
Sylvester Comprehensive Cancer Center - PlantationPlantationFlorida33324-
Emory University HospitalAtlantaGeorgia30322-
Emory University Hospital MidtownAtlantaGeorgia30308-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Sarah Cannon Research Institute - PharmacyNashvilleTennessee37203-
SCRI Oncology PartnersNashvilleTennessee37203-
Tristar BMTNashvilleTennessee37203-
TriStar Centennial Medical centerNashvilleTennessee37203-

Find similar trials in Coral Gables, FL

By research site
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center· Coral Gables, FLSylvester Comprehensive Cancer Center - Coral Springs· Coral Springs, FLUniversity of Miami Hospital and Clinics - Deerfield Beach· Deerfield Beach, FLUniversity of Miami Hospital and Clinics - Doral· Doral, FLSylvester Comprehensive Cancer Center - Hollywood· Hollywood, FLSylvester Comprehensive Cancer Center· Miami, FL

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