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NCT Number: NCT07426757

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

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.

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Key information

Conditions

Advanced Malignancies Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

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).

Treatment and study plan

PF-07994525

Drug

Oral administration

midazolam

Drug

Oral administration

Primary outcomes

  1. 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, 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)

  2. 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

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

  3. 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

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

  4. Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)

    Time frame: Baseline to end of DLT evaluation period

    Occurrence of DLTs as defined by the protocol

  5. 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

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

  6. 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

    Safety, and preliminary anti-tumor activity

Secondary 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)

  5. Duration of complete response (DOCR) 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)

  6. Progression-free survival (PFS) 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)

  7. Overall survival (OS)

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

  8. Single, Multiple Dose and food effect: Maximum Observed Concentration (Cmax)

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

    Pharmacokinetic (PK) assessments for PF-07994525

  9. Single, Multiple Dose and food effect: Time to Maximum concentration (Tmax)

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

    Pharmacokinetic (PK) assessments for PF-07994525

  10. Single, Multiple Dose and food effect: AUC from time zero to time of last measurable concentration (AUClast)

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

    Pharmacokinetic (PK) assessments for PF-07994525

  11. Single Dose and food effect: Terminal Elimination half-life (t1/2) as data permit

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

    Pharmacokinetic (PK) assessments for PF-07994525

  12. Single Dose and food effect: AUC versus time curve from time 0 extrapolated to infinity (AUCinf) as data permit

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

    Pharmacokinetic (PK) assessments for PF-07994525

  13. Single, Multiple Dose and food effect: apparent clearance of drug (CL/F) as data permit

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

    Pharmacokinetic (PK) assessments for PF-07994525

  14. Single, Multiple Dose and food effect: Apparent volume of distribution during terminal phase (Vz/F) as data permit

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

    Pharmacokinetic (PK) assessments for PF-07994525

  15. Multiple Dose: AUC at steady state over the dosing interval (AUCtau) as data permit

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

    Pharmacokinetic (PK) assessments for PF-07994525

  16. Multiple Dose: Cmin as data permit

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

    Pharmacokinetic (PK) assessments for PF-07994525

  17. Multiple Dose: Accumulation ratio (Rac) as data permit

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

    Pharmacokinetic (PK) assessments for PF-07994525

  18. AUC from time zero to time of last measurable concentration (AUClast)

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

    PK parameters of CYP3A4 probe substrate midazolam with and without PF-07994525

  19. Time to Maximum concentration (Tmax)

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

    PK parameters of CYP3A4 probe substrate midazolam with and without PF-07994525

  20. Maximum Observed Concentration (Cmax)

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

    PK parameters of CYP3A4 probe substrate midazolam with and without PF-07994525

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-07994525 IN PARTICIPANTS WITH ADVANCED MALIGNANCIES

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 23, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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