PF-07994525 in advanced cancers: a first-in-human dose-escalation study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label phase 1 study uses dose escalation (Part 1) to determine safety, tolerability, and preliminary antitumor activity of PF-07994525 in patients with relapsed/refractory multiple myeloma (MM). Part 2 expands the dose to additional MM patients to further assess safety, pharmacokinetics and pharmacodynamics, while gathering early signals of efficacy. Participants may receive PF-07994525 and, as needed for procedure or sedation, Midazolam. Eligibility requires adults with MM per IMWG criteria, measurable disease, and at least 3 prior lines of therapy with ECOG 0-1. The study is sponsored by Pfizer and conducted at three U.S. centers.

Why it matters

Who can join: the full rules

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).

Where it's running

• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• Presbyterian/St. Luke's Medical Center
  Denver, Colorado, United States Recruiting
• Smilow Cancer Hospital - Yale New Haven Health
  New Haven, Connecticut, United States Recruiting
• Yale-New Haven Hospital-Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Smilow Cancer Hospital Phase 1 Unit
  New Haven, Connecticut, United States Recruiting
• Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
  New Haven, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.