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Clinical Trials in the USA / NCT07426757
Recruiting Phase 1

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

NCT07426757 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 1
Started
2026-07-01
Last updated
2026-10-13

Condition(s) studied

Advanced MalignanciesAdvanced Cancer

Investigational drug(s) / intervention(s)

PF-07994525Midazolam →

PF-07994525: Oral administration

Midazolam: Oral administration

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Type, incidence and severity of participants with adverse events (AEs) — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
    Type, incidence, severity (graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0), timing, seriousness, and relatedness of adverse events (AEs)
  • Type, incidence and severity of participants with laboratory abnormalities — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
    Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities
  • Number of participants with dose modifications — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
    Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions, and treatment discontinuations) due to AEs
  • Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) — Baseline to end of DLT evaluation period
    Occurrence of DLTs as defined by the protocol
  • Part 1: Recommended Monotherapy Dose for Expansion (RDE) — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
    RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings
  • Part 2: Recommended Dose for future development — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
    Safety, and preliminary anti-tumor activity

Trial sites (26)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07426757 on ClinicalTrials.gov ↗ ← All trials in the USA