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

RecruitingPhase 1

AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-07994525 IN PARTICIPANTS WITH ADVANCED MALIGNANCIES

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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).

About the study

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.

What is being tested

Sponsor: Pfizer · Participants: 120 · Started: Jul 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07426757

Locations in the U.S.

ColoradoColorado Blood Cancer Institute, Denver
Presbyterian/St. Luke's Medical Center, Denver
FloridaSylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center, Coral Gables
Sylvester Comprehensive Cancer Center - Coral Springs, Coral Springs
University of Miami Hospital and Clinics - Deerfield Beach, Deerfield Beach
Sylvester Comprehensive Cancer Center- Doral, Doral
Sylvester Comprehensive Cancer Center - Hollywood, Hollywood
Sylvester Comprehensive Cancer Center, Miami
Sylvester Comprehensive Cancer Center- Kendall, Miami
University of Miami Hospital and Clinics, Miami
Sylvester Comprehensive Cancer Center - Sole Mia, North Miami
Sylvester Comprehensive Cancer Center - Plantation, Plantation
GeorgiaEmory University Hospital, Atlanta
Emory University Hospital Midtown, Atlanta
Winship Cancer Institute, Emory University, Atlanta
TennesseeSCRI Oncology Partners, Nashville
Sarah Cannon Research Institute - Pharmacy, Nashville
TriStar Centennial Medical center, Nashville
Tristar BMT, Nashville

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.