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New drug targets Hard-to-Treat cancers in early trial

NCT ID NCT06131840

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 4 times

Summary

This early-phase study tests an experimental drug called PF-08046050 in adults with advanced solid tumors (like lung, colon, or stomach cancer) that have come back or not improved with standard treatments. The drug is designed to stick to cancer cells and kill them. The main goal is to check safety and find the right dose.

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

About 914 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Sep 2030

An estimate. End dates often move.

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: 1. Tumor type: * Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available. * Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or pancreatic ductal adenocarcinoma (PDAC). * The tumor types to be enrolled in Part B will be identified by the sponsor from among those specified in Part A. * Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies. * CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and evidence of either progressive disease or intolerance to their last regimen. * PDAC with one or more metastatic lesions measurable by computed tomography/magnetic resonance imaging according to RECIST v1.1 criteria; and must have received no more than 1 prior chemotherapy regimen for the treatment of advanced PDAC and evidence of either progressive disease or intolerance to that regimen. * GC or GEJ and must have received prior platinum and fluoropyrimidine-based chemotherapy. * NSCLC and must have received platinum-based therapy. If eligible and consistent with local standard of care must have received a PD-1/PD-L1 inhibitor. In addition, participants with tumor genomic mutations/alterations for which approved targeted therapies are available per local standard of care, must have received such therapies. * Small cell lung cancer (SCLC) and must have received platinum-based therapy for extensive-stage disease and no more than 3 prior lines of therapy. If eligible and consistent with local standard of care must have received a PD 1/PD-L1 inhibitor. * CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen. * CRC participants in Part D and Part E (5FU/LV + bevacizumab and 5FU/LV + oxaliplatin + bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must not have received a prior TOPO1 inhibitor (such as irinotecan or nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for advanced disease. 2L cohorts (applicable to 5FU/LV + bevacizumab combination only): 1 prior chemotherapy regimen for the treatment of advanced disease, which must have included a fluoropyrimidine and oxaliplatin. \> 2L PDAC participants in Part E (5FU/LV combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. One or more metastatic lesions measurable by computed tomography/magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. \> 1L PDAC participants in Part E (5FU/LV + oxaliplatin combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been previously treated in the metastatic setting. One or more metastatic lesions measurable by computed tomography/magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. No prior chemotherapy for PDAC with the following exception: Patients who received adjuvant/neoadjuvant chemotherapy and who had recurrence more than 12 months after completion of adjuvant/neoadjuvant chemotherapy are eligible. 2. Participants enrolled in the following study parts should have a tumor site that is accessible for biopsy(ies) and agree to biopsy(ies) and/or submission of archival tissue: * Monotherapy dose optimization (Part B) * Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts 3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline. Exclusion Criteria: 1. Previous exposure to CEACAM5-targeted therapy. 2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan). 3. History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. 4. Active cerebral/meningeal disease related to the underlying malignancy. Participants with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the participant is clinically stable (defined as not having received steroid treatment for symptoms related to cerebral/meningeal disease for at least 2 weeks prior to enrollment and with no ongoing related AEs). \> Criteria related to bevacizumab administration (participants in Parts D and E) 5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients. 6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies. 7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture. 8. Deep venous thromboembolic event within 4 weeks prior to enrollment 9. Known coagulopathy that increases risk of bleeding, bleeding diatheses. 10. History of any life-threatening VEGF-related adverse event

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm gastric carcinoma gastric neoplasm gastroesophageal junction adenocarcinoma non-small cell lung carcinoma pancreatic ductal adenocarcinoma small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung Colorectal neoplasms Gastroesophageal junction adenocarcinoma Pancreatic ductal adenocarcinoma Small cell lung carcinoma Stomach neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ApoEx NKS

    RECRUITING

    Stockholm, 17176, Sweden

  • Ascires CETIR

    RECRUITING

    Esplugues de Llobregat, 08950, Spain

  • Ascires Cetir

    RECRUITING

    Barcelona, 08029, Spain

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    RECRUITING

    Duarte, California, 91010, United States

  • Diagnostic Centre

    RECRUITING

    London, W1G 7AF, United Kingdom

  • Edinburgh Cancer Centre, Western General Hospital

    RECRUITING

    Edinburgh, Scotland, EH4 2XU, United Kingdom

  • Florida Cancer Specialists

    RECRUITING

    Orlando, Florida, 32827, United States

  • Fudan University Shanghai Cancer Center

    NOT_YET_RECRUITING

    Shanghai, 201321, China

  • Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Hadassah Medical Organization

    NOT_YET_RECRUITING

    Jerusalem, 91120, Israel

  • Hospital Universitario HM Sanchinarro-CIOCC-START Madrid

    RECRUITING

    Madrid, 28050, Spain

  • IP Address: City of Hope Investigational Drug Services(IDS)

    RECRUITING

    Duarte, California, 91010, United States

  • Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    RECRUITING

    L'Hospitalet de Llobregat, Catalunya [cataluña], 08908, Spain

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, Paris, 94805, France

  • Karolinska University Hospital

    RECRUITING

    Solna, 171 64, Sweden

  • Lothian Health Board

    RECRUITING

    Edinburgh, EH3 9DN, United Kingdom

  • Mayo Clinic

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Cancer Center

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Hospital

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • MidAmerica Cancer Care

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64132, United States

  • NEXT Dallas

    NOT_YET_RECRUITING

    Irving, Texas, 75039, United States

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Netherlands Cancer Institute

    RECRUITING

    Amsterdam, 1066CX, Netherlands

  • Radiology

    RECRUITING

    London, W1G 8PP, United Kingdom

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    RECRUITING

    Salt Lake City, Utah, 84119, United States

  • Sarah Cannon Research Institute - Pharmacy

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    RECRUITING

    Orlando, Florida, 32827, United States

  • Servicio de Farmacia ICO - Planta 0

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Shandong First Medical University Cancer Hospital

    NOT_YET_RECRUITING

    Jinan, Shandong, 250117, China

  • Sidney Kimmel Comprehensive Cancer at Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • South Texas Accelerated Research Therapeutics Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • South Texas Accelerated Research Therapeutics, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • The Harley Street Clinic

    RECRUITING

    London, W1G 7LJ, United Kingdom

  • The Harley Street Clinic (THSC)

    RECRUITING

    London, Other, W1G 8BJ, United Kingdom

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510655, China

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University Health Network, Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Western General Hospital

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

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