Actively Recruiting
An Open-Label Phase 1 Study to Evaluate PF-07994525 in Participants With Advanced Malignancies
Led by Pfizer · Updated on 2026-06-01
120
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07994525 in participants with relapsed or refractory multiple myeloma (R/R MM). This open-label study includes participants with advanced malignancies and aims to assess how well this oral drug works and how the body processes it. The study is sponsored by Pfizer and is in Phase 1, focusing on dose escalation and dose expansion to find the best dose for further development. The study has two parts. Part 1 involves increasing doses of PF-07994525 given orally to assess safety and early antitumor effects in participants with R/R MM. Part 2 expands the dose evaluation to more participants to further examine safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. Some participants may also receive midazolam orally as part of the study. The study does not use blinding and includes open-label administration. Participants will be monitored from the first day of treatment through about two years after the last dose. Assessments include tracking adverse events, laboratory test abnormalities, dose modifications, and antitumor responses based on International Myeloma Working Group criteria. Researchers will measure survival rates, response durations, drug concentrations in the body, and other pharmacokinetic parameters. Safety and tolerability will be closely observed, and participants' health status will be regularly evaluated during and after treatment.
CONDITIONS
Brief Title
An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older (or minimum age of consent per local rules) at consent
- Prior diagnosis of multiple myeloma per International Myeloma Working Group criteria
- Measurable disease by serum or urine M-protein or abnormal free light chain levels
- Refractory or intolerant to all established multiple myeloma therapies with at least three prior lines of treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Active plasma cell leukemia, smoldering multiple myeloma, Waldenstr�f6m's macroglobulinemia, amyloidosis, or POEMS syndrome
- Autologous stem cell transplant within 12 weeks before enrollment or active graft-versus-host disease
- Active or suspected brain or meningeal disease related to cancer
- Any active, uncontrolled infection including COVID-19, hepatitis B or C, HIV/AIDS unless deemed not clinically significant by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years or until disease progression, death, or start of new anticancer therapy
Participants receive oral administration of PF-07994525 and Midazolam as part of the study treatment for advanced multiple myeloma.
Regular visits during treatment period
Duration - 30 to 37 days after the last study treatment, up to approximately 2 years
Participants are monitored for safety and treatment outcomes after the last dose of study treatment.
Periodic follow-up visits
Trial Site Locations
Total: 4 locations
1
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States, 37203
Actively Recruiting
2
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
Tristar BMT
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
TriStar Centennial Medical center
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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