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NCT07426757PHASE1Recruiting

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

Pfizer

Start Date

7/1/2026

Completion Date

7/10/2030

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at the time of informed consent. * Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al. 2014) Measurable disease based on IMWG criteria as defined by at least 1 of the following: 1. Serum M-protein \>0.5 g/dL by serum protein electrophoresis (SPEP) 2. Urinary M-protein excretion \>200 mg/24 hours by urine protein electrophoresis (UPEP) 3. Serum immunoglobulin Free Light Chain (FLC) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65) * Participants must be refractory to, or intolerant to, all established therapies known to provide clinical benefit in multiple myeloma that are an appropriate therapeutic option, in the judgement of the investigator. A minimum of 3 prior lines of therapy are required. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Exclusion Criteria: * Active plasma cell leukemia, Smoldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome. * Autologous stem cell transplant within 12 weeks prior to enrollment or active Graft-versus-host disease (GVHD). * Active or suspected cerebral/meningeal disease related to the underlying malignancy. * Any active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), known HIV or AIDS related illness, unless deemed not clinically significant by the investigator (eg, onychomycosis).

Interventions

DRUG

PF-07994525

DRUG

Midazolam

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Conditions

Advanced MalignanciesAdvanced Cancer

Locations

Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

Coral Gables, Florida 33146

United States

Sylvester Comprehensive Cancer Center - Coral Springs

Coral Springs, Florida 33065

United States

University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida 33442

United States

University of Miami Hospital and Clinics - Doral

Doral, Florida 33166

United States

Sylvester Comprehensive Cancer Center - Hollywood

Hollywood, Florida 33021

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

University of Miami Hospital and Clinics

Miami, Florida 33136

United States

Sylvester Comprehensive Cancer Center- Kendall

Miami, Florida 33176

United States

Sylvester Comprehensive Cancer Center - Sole Mia

North Miami, Florida 33181

United States

Sylvester Comprehensive Cancer Center - Plantation

Plantation, Florida 33324

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee 37203

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Tristar BMT

Nashville, Tennessee 37203

United States

TriStar Centennial Medical center

Nashville, Tennessee 37203

United States

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada