Experimental cancer drug trial halted early
NCT ID NCT05983133
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called PF-08046052/SGN-EGFRd2 in people with advanced solid tumors that could not be removed or had spread. The goal was to find a safe dose and check for side effects. The trial was terminated early, and it included people with colorectal, lung, head and neck, and pancreatic cancers.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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68 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Atrium Health Wake forest Baptist
Winston-Salem, North Carolina, 27157, United States
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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Huntsman Cancer Hospital, University of Utah
Salt Lake City, Utah, 84112, United States
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Huntsman Cancer Institute, University Of Utah
Salt Lake City, Utah, 84112, United States
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John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
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MD Anderson Cancer Center - University of Texas
Houston, Texas, 77030, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Moffitt Cancer Center McKinley Hospital
Tampa, Florida, 33612, United States
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Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
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Providence Portland Medical Center
Portland, Oregon, 97213, United States
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Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
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Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, 90404, United States
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The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
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UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404, United States
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University College London Hospital, NIHR UCLH Clinical Research Facility
London, W1T 7HA, United Kingdom
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Utah
Salt Lake City, Utah, 84112, United States
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Wake Forest Baptist Medical Center / Wake Forest University
Winston-Salem, North Carolina, 27157, United States
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