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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 		Monotherapy Dose Expansion
  • Drug: PF-07994525
    Oral administration
  • Drug: Midazolam
    Oral administration
Experimental
Part 2 		Monotherapy Dose Escalation
  • Drug: PF-07994525
    Oral administration

Recruiting Locations

Emory University Hospital Midtown
Atlanta, Georgia 30308

Emory University Hospital
Atlanta, Georgia 30322

Winship Cancer Institute, Emory University
Atlanta, Georgia 30322

Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee 37203

SCRI Oncology Partners
Nashville, Tennessee 37203

Tristar BMT
Nashville, Tennessee 37203

TriStar Centennial Medical center
Nashville, Tennessee 37203

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.