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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PF-08046052/SGN-EGFRd2 		PF-08046052/SGN-EGFRd2 monotherapy
  • Drug: PF-08046052
    Given into the vein (IV; intravenously)
    Other names:
    • SGN-EGFRd2

Recruiting Locations

Ronald Reagan UCLA Medical Center
Los Angeles 5368361, California 5332921 90095

UCLA Hematology/Oncology
Los Angeles 5368361, California 5332921 90095

Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica 5393212, California 5332921 90404

UCLA Hematology/Oncology - Santa Monica
Santa Monica 5393212, California 5332921 90404

Moffitt Cancer Center McKinley Hospital
Tampa 4174757, Florida 4155751 33612

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612

University of Iowa
Iowa City 4862034, Iowa 4862182 52242

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215

Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201

Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills 4992523, Michigan 5001836 48334

Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601

Atrium Health Wake forest Baptist
Winston-Salem 4499612, North Carolina 4482348 27157

Wake Forest Baptist Medical Center / Wake Forest University
Winston-Salem 4499612, North Carolina 4482348 27157

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106

Providence Cancer Institute Franz Clinic
Portland 5746545, Oregon 5744337 97213

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213

MD Anderson Cancer Center - University of Texas
Houston 4699066, Texas 4736286 77030

The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Huntsman Cancer Hospital, University of Utah
Salt Lake City 5780993, Utah 5549030 84112

Huntsman Cancer Institute, University Of Utah
Salt Lake City 5780993, Utah 5549030 84112

University of Utah
Salt Lake City 5780993, Utah 5549030 84112

More Details

Status
Recruiting
Sponsor
Seagen, a wholly owned subsidiary of Pfizer

Study Contact

Seagen Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com