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NCT Number: NCT07090499

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

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.

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Key information

Conditions

Advanced/Metastatic Solid Tumors Adenocarcinoma Adenocarcinoma Of Esophagus Adenocarcinoma of Lung Advanced Non-Small Cell Lung Cancer Bladder Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non Small Cell Lung Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Squamous Cell of Head and Neck Carcinoma, Transitional Cell Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Adenocarcinoma Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroesophageal Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Pancreatic Adenocarcinoma Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • Resolution of acute effects of prior anticancer therapy to baseline or Grade 1
  • Consent to submit required pre-treatment tumor tissue as medically feasible

Exclusion criteria

  • 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

Treatment and study plan

PF-08046876

Drug

Intravenous administration

Primary outcomes

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

    Time frame: 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

    Time frame: Baseline to end of DLT evaluation period

    Occurrence of DLTs as defined by the protocol

  3. Part 1: Recommended Monotherapy Dose for Expansion

    Time frame: Baseline to 30 days post last study drug administration

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

  4. Part 2: Recommended Phase 2 Dose

    Time frame: 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.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 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)

    Time frame: 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)

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

    PFS as defined per RECIST 1.1.

  4. Overall Survival (OS)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

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

    To evaluate the immunogenicity of PF-08046876.

  9. Incidence of Neutralizing Antibodies (NAb)

    Time frame: 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

    Time frame: 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.

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

A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 29, 2025
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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