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Experimental cancer drug trial halted early

NCT ID NCT05983133

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

68 people

The number who actually took part.

Started

Nov 2023

Finished

Apr 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Atrium Health Wake forest Baptist

    Winston-Salem, North Carolina, 27157, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, 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

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Karmanos Cancer Institute Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334, United States

  • MD Anderson Cancer Center - University of Texas

    Houston, Texas, 77030, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Moffitt Cancer Center McKinley Hospital

    Tampa, Florida, 33612, United States

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Santa Monica UCLA Medical Center & Orthopaedic Hospital

    Santa Monica, California, 90404, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095, United States

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404, United States

  • University College London Hospital, NIHR UCLH Clinical Research Facility

    London, W1T 7HA, United Kingdom

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • Wake Forest Baptist Medical Center / Wake Forest University

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.