Recruiting
Phase 1

PF-07994525

Sponsor:

Pfizer

Code:

NCT07426757

Conditions

Advanced Malignancies

Advanced Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-07994525

Midazolam

Study Details

Brief summary:

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

Advanced Malignancies

Advanced Cancer

Study ID

NCT07426757

Start date

Jul 1, 2026

Status verified date

Sep, 2026

Completion date

Jul 10, 2030

Anticipated

Primary completion date

Jul 10, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1

Monotherapy Dose Expansion

experimental: Part 2

Monotherapy Dose Escalation

Interventions

PF-07994525

Oral administration

Midazolam

Oral administration

Primary outcome measure

  • Type, incidence and severity of participants with adverse events (AEs) [ Time Frame: From the first day through 30-37 days after the last study treatment, up to approximately 2 years ]
  • Type, incidence and severity of participants with laboratory abnormalities [ Time Frame: From the first day through 30-37 days after the last study treatment, up to approximately 2 years ]
  • Number of participants with dose modifications [ Time Frame: From the first day through 30-37 days after the last study treatment, up to approximately 2 years ]
  • Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: Baseline to end of DLT evaluation period ]
  • Part 1: Recommended Monotherapy Dose for Expansion (RDE) [ Time Frame: From the first day through 30-37 days after the last study treatment, up to approximately 2 years ]
  • Part 2: Recommended Dose for future development [ Time Frame: From the first day through 30-37 days after the last study treatment, up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

Recruiting

Coral Gables, Florida, United States, 33146

Sylvester Comprehensive Cancer Center - Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

University of Miami Hospital and Clinics - Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Sylvester Comprehensive Cancer Center- Doral

Recruiting

Doral, Florida, United States, 33166

Sylvester Comprehensive Cancer Center - Hollywood

Recruiting

Hollywood, Florida, United States, 33021

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

University of Miami Hospital and Clinics

Recruiting

Miami, Florida, United States, 33136

Sylvester Comprehensive Cancer Center- Kendall

Recruiting

Miami, Florida, United States, 33176

Sylvester Comprehensive Cancer Center - Sole Mia

Recruiting

North Miami, Florida, United States, 33181

Sylvester Comprehensive Cancer Center - Plantation

Recruiting

Plantation, Florida, United States, 33324

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Sarah Cannon Research Institute - Pharmacy

Recruiting

Nashville, Tennessee, United States, 37203

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Tristar BMT

Recruiting

Nashville, Tennessee, United States, 37203

TriStar Centennial Medical center

Recruiting

Nashville, Tennessee, United States, 37203

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

University Health Network- Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G2M9

More Information

Sponsor

Pfizer

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Advanced Malignancies
  • Advanced Cancers
  • Advanced Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-09-04.