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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
PF-07994525
DrugOral administration
Midazolam
DrugOral administration
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Part 1Experimental treatment 2 interventions
Group B: Part 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Type, incidence and severity of participants with adverse events (AEs)
Type, incidence, severity (graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0), timing, seriousness, and relatedness of adverse events (AEs)
Time frame
From the first day through 30-37 days after the last study treatment, up to approximately 2 years2
Type, incidence and severity of participants with laboratory abnormalities
Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities
Time frame
From the first day through 30-37 days after the last study treatment, up to approximately 2 years3
Number of participants with dose modifications
Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions, and treatment discontinuations) due to AEs
Time frame
From the first day through 30-37 days after the last study treatment, up to approximately 2 years4
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Occurrence of DLTs as defined by the protocol
Time frame
Baseline to end of DLT evaluation periodSecondary outcomes
1
Objective response rate (ORR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator.
Time frame
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)2
Complete response rate (CRR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator.
Time frame
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)3
Time to response (TTR) per IMWG as determined by investigator
Time frame
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)4
Duration of response (DOR) per IMWG as determined by investigator
Time frame
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years) Source ClinicalTrials.gov