An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers

NCT07426757 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: C6331001KAT2i
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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

Keywords

Advanced Malignancies; Advanced Cancers; Advanced Cancer

Outcome Measures

Primary Outcomes (6)

• 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)

  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

  Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities

  From the first day through 30-37 days after the last study treatment, up to approximately 2 years

• Number of participants with dose modifications

  Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions, and treatment discontinuations) due to AEs

  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)

  Occurrence of DLTs as defined by the protocol

  Baseline to end of DLT evaluation period

• Part 1: Recommended Monotherapy Dose for Expansion (RDE)

  RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings

  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

  Safety, and preliminary anti-tumor activity

  From the first day through 30-37 days after the last study treatment, up to approximately 2 years

Secondary Outcomes (20)

• Objective response rate (ORR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator.

  Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)

• Complete response rate (CRR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator.

  Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)

• Time to response (TTR) per IMWG as determined by investigator

  Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)

• Duration of response (DOR) per IMWG as determined by investigator

  Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)

• Duration of complete response (DOCR) per IMWG as determined by investigator

  Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)

Study Arms (2)

Part 1

EXPERIMENTAL

Monotherapy Dose Escalation

Drug: PF-07994525; Drug: Midazolam

Part 2

EXPERIMENTAL

Monotherapy Dose Expansion

Drug: PF-07994525

Interventions

PF-07994525 DRUG

Oral administration

Part 1; Part 2

Midazolam DRUG

Oral administration

Part 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee, 37203, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Tristar BMT

Nashville, Tennessee, 37203, United States

RECRUITING

TriStar Centennial Medical center

Nashville, Tennessee, 37203, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): July 10, 2029
• Study Completion (Estimated): July 10, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)