An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
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
Qualifiers
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)
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)
Disqualifiers
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).
Trial design
Treatments tested in this trial
- PF-07994525
- Midazolam
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov