NCT07426757 An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers
| NCT ID | NCT07426757 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pfizer |
| Condition | Advanced Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2029-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2026-05-15 with a primary completion date of 2029-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07426757 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07426757 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07426757 currently recruiting?
Yes, NCT07426757 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07426757 trial being conducted?
This trial is being conducted at Nashville, United States, Nashville, United States, Nashville, United States, Nashville, United States.
Who is sponsoring the NCT07426757 clinical trial?
NCT07426757 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 120 participants.