NCT07426757From ClinicalTrials.govRecruiting

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

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

Advanced Malignancies
Advanced Cancer

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 120
Started: 1 July 2026
Main results due: 10 July 2029
Study sites: 21
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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).

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(21)

Colorado Blood Cancer Institute
Denver, Colorado, United States
Recruiting
Presbyterian/St. Luke's Medical Center
Denver, Colorado, United States
Recruiting
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida, United States
Recruiting
Sylvester Comprehensive Cancer Center - Coral Springs
Coral Springs, Florida, United States
Recruiting
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, United States
Recruiting
Sylvester Comprehensive Cancer Center- Doral
Doral, Florida, United States
Recruiting
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood, Florida, United States
Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Recruiting
University of Miami Hospital and Clinics
Miami, Florida, United States
Recruiting
Sylvester Comprehensive Cancer Center- Kendall
Miami, Florida, United States
Recruiting
Sylvester Comprehensive Cancer Center - Sole Mia
North Miami, Florida, United States
Recruiting
Sylvester Comprehensive Cancer Center - Plantation
Plantation, Florida, United States
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Recruiting
Emory University Hospital
Atlanta, Georgia, United States
Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Recruiting
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
Recruiting
SCRI Oncology Partners
Nashville, Tennessee, United States
Recruiting
Tristar BMT
Nashville, Tennessee, United States
Recruiting
TriStar Centennial Medical center
Nashville, Tennessee, United States
Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Recruiting
University Health Network- Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Recruiting

Showing 21 of 21 sites. 21 of the 21 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07426757. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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