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

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

INTRODUCTION

  • Org Study ID: C5951001
  • Secondary ID: N/A
  • NCT ID: NCT07090499
  • Sponsor: Pfizer

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    August 20, 2025
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation

Primary Outcome 1 - Timeframe: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)

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

Primary Outcome 2 - Timeframe: Baseline to end of DLT evaluation period

Primary Outcome 3 - Measure: Part 1: Recommended Monotherapy Dose for Expansion

Primary Outcome 3 - Timeframe: Baseline to 30 days post last study drug administration

Primary Outcome 4 - Measure: Part 2: Recommended Phase 2 Dose

Primary Outcome 4 - Timeframe: Baseline to 30 days post last study drug administration

CONDITION

  • Advanced/Metastatic Solid Tumors
  • Bladder Cancer
  • Urothelial Carcinoma
  • Advanced Non-Small Cell Lung Cancer
  • Carcinoma
  • Non Small Cell Lung
  • Carcinoma
  • Squamous Cell of Head and Neck
  • Head and Neck Cancer
  • Esophageal Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Esophageal Squamous Cell Carcinoma
  • Esophageal Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Pancreatic Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: [email protected]

LOCATION

Facility Status Contact
Facility: City of Hope National Medical Center
Duarte, California 91010
United States
Status: Recruiting Contact: N/A
Facility: City of Hope at Irvine Lennar
Irvine, California 92618
United States
Status: Recruiting Contact: N/A
Facility: Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut 06510
United States
Status: Recruiting Contact: N/A
Facility: Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut 06510
United States
Status: Recruiting Contact: N/A
Facility: Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut 06511
United States
Status: Recruiting Contact: N/A
Facility: Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut 06611
United States
Status: Recruiting Contact: N/A
Facility: Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Status: Recruiting Contact: N/A
Facility: Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: N/A
Facility: Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts 02467
United States
Status: Recruiting Contact: N/A
Facility: Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: NEXT Oncology
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A