A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

NCT07090499
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
540
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Lead sponsor
Pfizer
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Start date
2025-08-20
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Number of sites
31
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Summary
The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them. The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.
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Short title
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
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Official title
A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-07-08
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First posted
2025-07-29
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Registry last updated
2026-10-13
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Primary completion date
2028-07-08
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Start date
2025-08-20
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Participants
540
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Participant count basis
Estimated
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Planned participants
540
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Protocol amendments
2
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Number of sites
31
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07090499
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ClinicalTrials.gov ID
NCT07090499
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Registry record
Open registry record
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Allocation
Not applicable
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation

    Timeframe: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)

    AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.

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

    Timeframe: Baseline to end of DLT evaluation period

    Occurrence of DLTs as defined by the protocol

  3. Part 1: Recommended Monotherapy Dose for Expansion

    Timeframe: Baseline to 30 days post last study drug administration

    RDE will be based on cumulative safety, preliminary anti-tumor activity and pharmacokinetics findings

  4. Part 2: Recommended Monotherapy Phase 2 Dose

    Timeframe: Baseline to 30 days post last study drug administration

    RP2D will be determined based on the cumulative safety, preliminary anti-tumor activity, and pharmacokinetics findings.

  5. Part 3: Recommended Combination Phase 2 Dose/ Recommended Combination Dose for Expansion

    Timeframe: Baseline to 30 days post last study drug administration

    RP2D/RDE will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings.

  1. Objective Response Rate (ORR)

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

    ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

  2. Duration of Response (DOR)

    Timeframe: From the date of the first objective response to the date of disease progression or death (approximately 2 years)

    DOR as defined per RECIST 1.1.

  3. Progression Free Survival (PFS)

    Timeframe: From Baseline to date of first disease progression or death (approximately 2 Years)

    PFS as defined per RECIST 1.1.

  4. Overall Survival (OS)

    Timeframe: From baseline to up to 3 years

    OS defined as the time until death due to any cause.

  5. Pharmacokinetics (PK): Maximum Observed Serum Concentration (Cmax)

    Timeframe: Baseline to approximately 30 days after last dose of study drug

    Evaluate the single and multiple dose PK of PF-08048676.

  6. PK: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Timeframe: Baseline to approximately 30 days after last dose of study drug

    Evaluate the single and multiple dose PK of PF-08048676.

  7. PK: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)

    Timeframe: Baseline to approximately 30 days after last dose of study drug

    Evaluate the single and multiple dose PK of PF-08048676.

  8. Incidence of Anti-Drug Antibody (ADA)

    Timeframe: Baseline to approximately 30 days after last dose of study drug

    To evaluate the immunogenicity of PF-08046876.

  9. Incidence of Neutralizing Antibodies (NAb)

    Timeframe: Baseline to approximately 30 days after last dose of study drug

    To evaluate the immunogenicity of PF-08046876.

  10. Percent change of immune cells within tumors based on multiplex immunofluorescence

    Timeframe: Baseline through 4-7 weeks after first dose of study drug

    This measure will assess changes in the presence or activation of immune cells in the tumor microenvironment using RNA and/or Immunohistochemistry (IHC) assays.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 18 years of age or older
  • Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas
  • Measurable disease
  • ECOG Performance status 0-1
  • Part 1: progression or relapse following standard treatments
  • Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting
  • Part 3: advanced cancer of the lung or bladder, prior treatment requirements vary by combination therapy group
  • Resolution of acute effects of prior anticancer therapy to baseline or Grade 1
  • Consent to submit required pre-treatment tumor tissue as medically feasible

  • Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )
  • Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocol exclusion
  • Pulmonary disease meeting protocol exclusion
  • Other unacceptable abnormalities as defined by protocol
  • Part 3: Meet contraindications of combination products per protocol and/or local labels
Sources for eligibility
clinicaltrials.gov

  • City of Hope National Medical CenterDuarte, United StatesRecruiting
  • City of Hope at Irvine LennarIrvine, United StatesRecruiting
  • Ronald Reagan UCLA Medical CenterLos Angeles, United StatesNot yet recruiting
  • UCLA Department of Medicine-Hematology/OncologyLos Angeles, United StatesNot yet recruiting
  • Santa Monica UCLA Medical Center & Orthopaedic HospitalSanta Monica, United StatesNot yet recruiting
  • UCLA Hematology/Oncology - Santa MonicaSanta Monica, United StatesNot yet recruiting
  • Smilow Cancer Hospital - Yale New Haven HealthNew Haven, United StatesRecruiting
  • Yale - New Haven Hospital - Yale Cancer CenterNew Haven, United StatesRecruiting
  • Smilow Cancer Hospital Phase 1 UnitNew Haven, United StatesRecruiting
  • Smilow Cancer Hospital - TrumbullTrumbull, United StatesRecruiting
  • Brigham and Women's HospitalBoston, United StatesRecruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • Dana-Farber Cancer Institute - Chestnut HillNewton, United StatesRecruiting
  • Sarah Cannon Research Institute - PharmacyNashville, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • The University of Texas MD Anderson Cancer Center - ConroeConroe, United StatesRecruiting
  • University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • The University of Texas, MD Anderson Cancer Center - West HoustonHouston, United StatesRecruiting
  • The University of Texas, MD Anderson Cancer Center - League CityLeague City, United StatesRecruiting
  • NEXT OncologySan Antonio, United StatesRecruiting
  • The University of Texas, MD Anderson Cancer Center - Sugar LandSugar Land, United StatesRecruiting
  • Princess Margaret Cancer CentreToronto, CanadaRecruiting
  • Princess Margaret Cancer CentreToronto, CanadaRecruiting
  • McGill University Health CentreMontreal, CanadaRecruiting
  • Hunan Cancer HospitalChangsha, ChinaNot yet recruiting

And 6 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-521729-33-00
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (16)

Targets (1)