Phase 1 Study Evaluating Oral Drug PF-07994525 for Safety and Activity in Adults With Advanced Multiple Myeloma

What this Trial Is About

Researchers are evaluating PF-07994525, an oral drug, in participants with relapsed or refractory multiple myeloma RR MM and advanced malignancies. This open-label Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PF-07994525. The trial is sponsored by Pfizer and includes participants who have undergone at least three prior lines of therapy and have measurable disease according to established criteria. The study has two parts Part 1 involves dose escalation to determine the safety, tolerability, and recommended dose of PF-07994525 as a monotherapy. Part 2 expands the dose evaluation in additional participants to further assess safety and drug effects. Participants receive oral doses of PF-07994525, and in some assessments, midazolam is also administered orally to study drug interactions. The dose escalation and expansion phases will help guide future development of this treatment. Participants are involved in regular safety monitoring including assessment of adverse events and laboratory tests from the first day of treatment through up to approximately two years after the last dose. Researchers will measure response rates, time to response, duration of response, progression-free survival, overall survival, and detailed pharmacokinetic parameters. The study also tracks dose modifications and dose-limiting toxicities to understand treatment tolerability. Participation duration may vary depending on treatment response and safety outcomes.

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