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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07426757

Registry updated: 2026-10-13
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Description

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.

Interventions

  • PF-07994525 (Drug)
    Oral administration
  • Midazolam (Drug)
    Oral administration

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).

Conditions

Advanced Malignancies Advanced Cancer

Locations

  • Colorado Blood Cancer Institute — Denver, Colorado, United States
  • Presbyterian/St. Luke's Medical Center — Denver, Colorado, United States
  • Smilow Cancer Hospital - Yale New Haven Health — New Haven, Connecticut, United States
  • Yale-New Haven Hospital-Yale Cancer Center — New Haven, Connecticut, United States
  • Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States
  • Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP — New Haven, Connecticut, United States
  • Smilow Cancer Hospital - North Haven — North Haven, Connecticut, United States
  • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center — Coral Gables, Florida, United States
  • Sylvester Comprehensive Cancer Center - Coral Springs — Coral Springs, Florida, United States
  • University of Miami Hospital and Clinics - Deerfield Beach — Deerfield Beach, Florida, United States
  • Sylvester Comprehensive Cancer Center- Doral — Doral, Florida, United States
  • Sylvester Comprehensive Cancer Center - Hollywood — Hollywood, Florida, United States
  • Sylvester Comprehensive Cancer Center — Miami, Florida, United States
  • University of Miami Hospital and Clinics — Miami, Florida, United States
  • Sylvester Comprehensive Cancer Center- Kendall — Miami, Florida, United States
  • Sylvester Comprehensive Cancer Center - Sole Mia — North Miami, Florida, United States
  • Sylvester Comprehensive Cancer Center - Plantation — Plantation, Florida, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Emory University Hospital — Atlanta, Georgia, United States
  • Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
  • Sarah Cannon Research Institute - Pharmacy — Nashville, Tennessee, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • Tristar BMT — Nashville, Tennessee, United States
  • TriStar Centennial Medical center — Nashville, Tennessee, United States
  • Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
  • University Health Network- Princess Margaret Cancer Centre — Toronto, Ontario, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record