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

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

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.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Squamous Cell Carcinoma of the Head and Neck; Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: PF-08046052

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W1T 7HA
    • University College London Hospital, NIHR UCLH Clinical Research Facility
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology
    • Santa Monica, California, United States, 90404
      • UCLA Hematology/Oncology - Santa Monica
    • Santa Monica, California, United States, 90404
      • Santa Monica UCLA Medical Center & Orthopaedic Hospital
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center McKinley Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
    • Farmington Hills, Michigan, United States, 48334
      • Karmanos Cancer Institute Weisberg Cancer Treatment Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center / Wake Forest University
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Cancer Institute Franz Clinic
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center - University of Texas
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute, University of Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Hospital, University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-08046052/SGN-EGFRd2; PF-08046052/SGN-EGFRd2 monotherapy	Drug: PF-08046052; Given into the vein (IV; intravenously); Other Names: SGN-EGFRd2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention	Through 90 days after last study treatment, up to approximately 1 year
Number of participants with laboratory abnormalities		Through 30-37 days after last study treatment, up to approximately 1 year
Number of participants with dose limiting toxicities (DLTs)		Up to 35 days
Number of participants with DLTs by dose level		Up to 35 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with antidrug antibodies (ADAs)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
Pharmacokinetic (PK) parameter - Area under the curve (AUC)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Maximum concentration (Cmax)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Time to maximum concentration (Tmax)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Apparent terminal half-life (t1/2)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Trough concentration (Ctrough)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
Objective response rate (ORR)	ORR is defined as the proportion of participants with an objective response per Response Evaluation in Solid Tumors (RECIST) 1.1 per investigator. A participant is determined to have an objective response if, based on RECIST 1.1, they achieve a complete response (CR) or partial response (PR) after initiation of treatment and at or prior to the EOT disease assessment.	Up to approximately 2 years
Duration of response (DOR)	DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause, whichever comes first	Up to approximately 2 years
Progression-free survival (PFS)	PFS is defined as the time from start of SGN-EGFRd2 to first documentation of disease progression or death due to any cause, whichever comes first	Up to approximately 2 years
Overall survival (OS)	OS is defined as the time from start of SGN-EGFRd2 to date of death due to any cause	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Seagen, a wholly owned subsidiary of Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Actual): April 16, 2026
• Study Completion (Actual): April 16, 2026

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; HNSCC; Seattle Genetics; Rectal Cancer; Colon Cancer; CRC; PDAC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Rectal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SGNEGFRd2-001; C5841001 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No