Study Stopped
The trial was terminated for strategic reasons. The decision was not based on any safety concerns
A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors
A Phase 1 Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors
2 other identifiers
interventional
68
2 countries
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2023
Typical duration for phase_1
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 9, 2023
CompletedStudy Start
First participant enrolled
November 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2026
CompletedMay 5, 2026
April 1, 2026
2.4 years
August 1, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (10)
Number of participants with antidrug antibodies (ADAs)
Through 30-37 days after last study treatment, up to approximately 1 year
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Maximum concentration (Cmax)
Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Time to maximum concentration (Tmax)
Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Apparent terminal half-life (t1/2)
Through 30-37 days after last study treatment, up to approximately 1 year
- +5 more secondary outcomes
Study Arms (1)
PF-08046052/SGN-EGFRd2
EXPERIMENTALPF-08046052/SGN-EGFRd2 monotherapy
Interventions
Given into the vein (IV; intravenously)
Eligibility Criteria
You may qualify if:
- 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
- +8 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
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
University College London Hospital, NIHR UCLH Clinical Research Facility
London, W1T 7HA, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2023
First Posted
August 9, 2023
Study Start
November 14, 2023
Primary Completion
April 16, 2026
Study Completion
April 16, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.