An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers
18 Years and older, Male and Female
C6331001 (primary)
NCI-2026-04029
KAT2i
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
- 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:
- Serum M-protein >0.5 g/dL by serum protein electrophoresis (SPEP)
- Urinary M-protein excretion >200 mg/24 hours by urine protein electrophoresis (UPEP)
- 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.
Treatment Sites in Georgia
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