ACTIVE_NOT_RECRUITING

A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors

Conditions

Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung Squamous Cell Carcinoma of the Head and Neck Pancreatic Ductal Adenocarcinoma CRC Colon Cancer Rectal Cancer NSCLC HNSCC PDAC Seattle Genetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will test the safety of a drug called PF-08046052/SGN-EGFRd2 in participants with advanced solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much PF-08046052/SGN-EGFRd2 should be given to participants. Part C will use the dose found in parts A and B to find out how safe PF-08046052/SGN-EGFRd2 is and if it works to treat solid tumor cancers.

Official Title

A Phase 1 Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors

Quick Facts

Study Start:2023-11-14

Study Completion:2026-08-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05983133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Tumor types: * For Part A: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment. Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from one of the following tumor types: * Colorectal cancer (CRC) * Non-small cell lung cancer (NSCLC) * Head and neck squamous cell cancer (HNSCC)-non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible. * For Part B: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment. * The tumor type(s) to be enrolled in dose optimization will be identified by the sponsor from among those specified in Part A. * For Part C: Participants must have disease that is relapsed or refractory or be intolerant to standard of care therapies as specified below, unless contraindicated: * CRC * Participants must have unresectable locally advanced or metastatic CRC. * Prior therapy: Participants must have received prior fluoropyrimidine, oxaliplatin and irinotecan. Participants with defective mismatch repair and microsatellite instability high (dMMR/MSI-H) should have received prior treatment with pembrolizumab, a nivolumab-containing regimen, or other available anti-PD-1 (programmed cell death protein 1) or anti PD L1 (programmed cell death 1 ligand) agents. * NSCLC * Participants must have unresectable locally advanced or metastatic NSCLC. * Prior therapy: Participants must have received platinum-based therapy and at least 1 PD-1/PD-L1 inhibitor. These agents may have been administered either as single agents or in combination. Participants with an activating mutation or rearrangement (eg, EGFR, anaplastic lymphoma kinase \[ALK\], etc.) must have received available targeted agents if eligible by biomarker status and local standard of care. * HNSCC * Participants must have unresectable locally advanced or metastatic HNSCC - non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible. * Prior therapy: Participants must have received platinum-based therapy and a PD-1/PD-L1 inhibitor, if eligible by biomarker status and local standard of care. These agents may have been administered either as single agents or in combination. * Pancreatic ductal adenocarcinoma (PDAC) * Participants must have unresectable locally advanced or metastatic PDAC. * Prior therapy: Participants must have received gemcitabine- or FOLFIRINOX-based therapy. * Participants should provide archival tumor tissue if available and also agree to biopsies, if medically feasible * An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Measurable disease at baseline per RECIST 1.1 criteria.	* History of another malignancy within 3 years before the first dose of study treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death * Known active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are * clinically stable for at least 4 weeks prior to study entry after brain metastases treatment, * they have no new or enlarging brain metastases, * and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. * Treatment with an aminobisphosphonate IV (eg ibandronate, pamidronate, zoledronate, etc.) within 4 weeks of the first dose of study treatment. * Participants with history of thromboembolic phenomena within 6 months prior to the first dose of study intervention, or with contraindication to thromboembolism prophylaxis (if clinically indicated) for a previous history of thrombus.

Inclusion Criteria

Exclusion Criteria

* Tumor types:
* For Part A: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment. Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from one of the following tumor types:
* Colorectal cancer (CRC)
* Non-small cell lung cancer (NSCLC)
* Head and neck squamous cell cancer (HNSCC)-non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible.
* For Part B: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment.
* The tumor type(s) to be enrolled in dose optimization will be identified by the sponsor from among those specified in Part A.
* For Part C: Participants must have disease that is relapsed or refractory or be intolerant to standard of care therapies as specified below, unless contraindicated:
* CRC
* Participants must have unresectable locally advanced or metastatic CRC.
* Prior therapy: Participants must have received prior fluoropyrimidine, oxaliplatin and irinotecan. Participants with defective mismatch repair and microsatellite instability high (dMMR/MSI-H) should have received prior treatment with pembrolizumab, a nivolumab-containing regimen, or other available anti-PD-1 (programmed cell death protein 1) or anti PD L1 (programmed cell death 1 ligand) agents.
* NSCLC
* Participants must have unresectable locally advanced or metastatic NSCLC.
* Prior therapy: Participants must have received platinum-based therapy and at least 1 PD-1/PD-L1 inhibitor. These agents may have been administered either as single agents or in combination. Participants with an activating mutation or rearrangement (eg, EGFR, anaplastic lymphoma kinase \[ALK\], etc.) must have received available targeted agents if eligible by biomarker status and local standard of care.
* HNSCC
* Participants must have unresectable locally advanced or metastatic HNSCC - non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible.
* Prior therapy: Participants must have received platinum-based therapy and a PD-1/PD-L1 inhibitor, if eligible by biomarker status and local standard of care. These agents may have been administered either as single agents or in combination.
* Pancreatic ductal adenocarcinoma (PDAC)
* Participants must have unresectable locally advanced or metastatic PDAC.
* Prior therapy: Participants must have received gemcitabine- or FOLFIRINOX-based therapy.
* Participants should provide archival tumor tissue if available and also agree to biopsies, if medically feasible
* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Measurable disease at baseline per RECIST 1.1 criteria.

* History of another malignancy within 3 years before the first dose of study treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
* Known active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are
* clinically stable for at least 4 weeks prior to study entry after brain metastases treatment,
* they have no new or enlarging brain metastases,
* and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug.
* Treatment with an aminobisphosphonate IV (eg ibandronate, pamidronate, zoledronate, etc.) within 4 weeks of the first dose of study treatment.
* Participants with history of thromboembolic phenomena within 6 months prior to the first dose of study intervention, or with contraindication to thromboembolism prophylaxis (if clinically indicated) for a previous history of thrombus.

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center

STUDY_DIRECTOR

Pfizer

Study Locations (Sites)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095

United States

UCLA Hematology/Oncology

Los Angeles, California, 90095

United States

Santa Monica UCLA Medical Center & Orthopaedic Hospital

Santa Monica, California, 90404

United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, 90404

United States

Moffitt Cancer Center McKinley Hospital

Tampa, Florida, 33612

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

University of Iowa

Iowa City, Iowa, 52242

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Atrium Health Wake forest Baptist

Winston-Salem, North Carolina, 27157

United States

Wake Forest Baptist Medical Center / Wake Forest University

Winston-Salem, North Carolina, 27157

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

MD Anderson Cancer Center - University of Texas

Houston, Texas, 77030

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Huntsman Cancer Hospital, University of Utah

Salt Lake City, Utah, 84112

United States

Huntsman Cancer Institute, University Of Utah

Salt Lake City, Utah, 84112

United States

University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-14

Study Completion Date2026-08-14

Study Record Updates

Study Start Date2023-11-14

Study Completion Date2026-08-14

Terms related to this study

Keywords Provided by Researchers

CRC
Colon Cancer
Rectal Cancer
NSCLC
HNSCC
PDAC
Seattle Genetics

Additional Relevant MeSH Terms

Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Squamous Cell Carcinoma of the Head and Neck
Pancreatic Ductal Adenocarcinoma