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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-20

Study Completion Date

2029-07-08

Brief Summary

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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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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 2 Dose Optimization

Participants will be randomized to 2 dosing regimens deemed to be safe in Part 1

Group Type EXPERIMENTAL

PF-08046876

Intervention Type DRUG

Intravenous administration

Part 2 Dose Expansion

Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1

Group Type EXPERIMENTAL

PF-08046876

Intervention Type DRUG

Intravenous administration

Part 1 Dose Escalation

Different groups of participants will receive different doses and/or schedules of the study drug

Group Type EXPERIMENTAL

PF-08046876

Intervention Type DRUG

Intravenous administration

Interventions

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PF-08046876

Intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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