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Lung cancer drug trial halted early: what we know

NCT ID NCT05652868

Disease control Sponsor: Mythic Therapeutics Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tested a new drug called MYTX-011 for people with advanced non-small cell lung cancer (NSCLC) that had spread or come back after standard treatments. The drug is an antibody-drug conjugate designed to deliver a powerful chemotherapy directly to cancer cells. The study was terminated, but it aimed to find a safe dose and check if the drug could shrink tumors.

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

227 people

The number who actually took part.

Started

Mar 2023

Finished

Nov 2025

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: Part 1: * Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC and have received available standard of care therapy. * There is no limit on the number of prior therapies that can have been received. Part 2 Cohorts A-D and F 1. Known to not have an actionable EGFR mutation. Subjects with or without other driver mutations are permitted to enroll. 2. Must have received (or be ineligible for) available standard of care therapy. 3. Must have progressed on at least 1 line of prior systemic therapy in the locally advanced/metastatic setting. Note: multiple TKIs for the same actionable mutation count as 1 line of therapy. Rechallenge of the same therapy regimen within 6 months of discontinuation date of the therapy is not considered a separate line of therapy. Maintenance therapy is not considered a separate line of therapy. Adjuvant and neoadjuvant therapies count as 1 line of therapy if given within 6 months before study entry. The same rules above apply to all inclusion/exclusion criteria regarding prior lines of therapy. 4. Subjects without any actionable gene alteration: must have progressed on (or be considered ineligible for), or be intolerant to, platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy) and have not received more than 2 lines of prior systemic therapy in the locally advanced/metastatic setting. 5. Subjects with actionable gene alterations (other than EGFR) for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase \[ALK\] translocation): must have progressed on (or be considered ineligible for), or be intolerant to, anticancer therapy targeting driver gene alterations and platinum-based chemotherapy and have not received more than 3 lines of prior systemic therapy in the locally advanced/metastatic setting. 6. Subjects with actionable gene alterations (other than MET exon 14 skipping mutation) for which immune checkpoint inhibitor is standard of care: must have progressed on (or be considered ineligible for), or be intolerant to, anticancer therapy targeting driver gene alteration and platinum-based chemotherapy, and also progressed on (or be considered ineligible for) or be intolerant to immune checkpoint inhibitor(as monotherapy or in combination with platinum-based chemotherapy, and have not received more than 3 lines of prior systemic therapy in the locally advanced/metastatic setting. 7. Subjects with MET exon 14 skipping mutation must have progressed on, or be intolerant to, at least one MET TKI if available, and have not received more than 2 lines of prior systemic therapy in the locally advanced/metastatic setting. Part 2: Cohort A: * Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC without EGFR mutation. * Tumor sample with high cMET expression by IHC confirmed by central laboratory testing. Cohort B: * Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC without EGFR mutation. * Tumor sample with intermediate cMET expression by IHC confirmed by central laboratory testing. Cohort B2 * Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC without EGFR mutation. * Tumor sample with intermediate cMET expression by IHC confirmed by central laboratory testing. Cohort C: * Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic squamous NSCLC without EGFR mutation. * Tumor sample with cMET expression by IHC confirmed by central laboratory testing. Cohort D: * Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous or adenosquamous NSCLC without EGFR mutation. * Tumor sample with low cMET expression on tumor biopsy confirmed centrally by IHC that does not meet inclusion criteria for Cohorts A, B, or B2. Cohort E: * Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for a curative therapy), or metastatic NSCLC with actionable EGFR mutations. * Tumor sample with high or intermediate cMET expression by IHC confirmed by central laboratory testing. * Must have received an available standard of care therapy and have progressed on at least 1 and no more than 3 lines of prior systemic therapy in the locally advanced/metastatic setting. Cohort E2 * Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic NSCLC with actionable EGFR mutations. * Tumor sample with high or intermediate cMET expression by IHC confirmed by central laboratory testing. * Must have received an available standard of care therapy and have progressed on at least 1 line and no more than 3 lines of prior systemic therapy in the locally advanced/metastatic setting. Cohort F * Have histologically or cytologically confirmed locally advanced non-squamous or adenosquamous NSCLC without EGFR mutation. * Have ultra-low cMET expression on tumor biopsy confirmed centrally by IHC that does not meet inclusion criteria for Cohorts A,B, B2, or D. All patients (Part 1 and Part 2) Inclusion Criteria: * Patient has at least one measurable lesion per RECIST 1.1 * ECOG performance status 0 or 1 * For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective method of birth control for the duration of the study treatment and for at least 6 months after the last dose of study drug. * Able to provide informed consent, and willing and able to comply with study protocol requirements Exclusion Criteria: Radiation to the lung within 6 weeks prior to screening. For all other sites (except lung), therapeutic or palliative radiation within 2 weeks prior to the first dose of study drug. Must have recovered from all radiation-related toxicity. Major surgery within 28 days of first dose of study drug administration. Untreated, uncontrolled central nervous system (CNS) metastases and/or leptomeningeal disease. * History of interstitial lung disease or pneumonitis that required treatment with systemic steroids or evidence of active interstitial lung disease or pneumonitis. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted. * Clinically significant systemic illness that could pose undue risk to the subject or confound the ability to interpret study results. * Active infection requiring IV antibiotics, antivirals, or antifungal medication within 14 Days of Cycle 1 Day 1 * Neuropathy \> Grade 1 * History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver disease. * Active or chronic corneal disorder * Conditions that may interfere with assessment of vision, such as monocular status or severe visual impairment in 1 or both eyes

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma non-small cell squamous lung carcinoma

As listed by the trial registrant

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

Advanced non-small cell lung cancer Advanced non-small cell non-squamous lung cancer Advanced non-small cell squamous lung cancer Non-small cell lung cancer NSCLC NSCLC stage IIIB NSCLC stage IV

Contacts and locations

Locations

  • APHM - Hopital de la Timone

    Marseille, France

  • Atlantic Health System

    Morristown, New Jersey, 07960, United States

  • Beatson West of Scotland Cancer Centre

    Glasgow, United Kingdom

  • Blacktown Hospital

    Blacktown, New South Wales, 2148, Australia

  • Cancer Research SA

    Adelaide, South Australia, 5011, Australia

  • Centre Léon Bérard - Lyon

    Lyon, France

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Chungbuk National Univ. Hospital

    Incheon, 21565, South Korea

  • Churchill Hospital - Oxford University Hospitals

    Oxford, OX3 7LJ, United Kingdom

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98019, United States

  • Gachon University

    Seongnam, South Korea

  • Gustave Roussy Institute

    Villejuif, France

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Hospital Clinico Universitario de Valencia

    Valencia, Spain

  • Hospital Quirónsalud Málaga

    Málaga, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Lozano Blesa

    Zaragoza, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • INSTITUT Curie (lead)

    Paris, France

  • Institut Bergonié-Bordeaux

    Bordeaux, France

  • Institut de Cancérologie de l'Ouest (ICO institute)-St Herblain

    Nantes, France

  • Instituto Oncológico Dr Rosell (IOR) - Hospital Univ. Dexeus

    Barcelona, Spain

  • Kosin Univ. Gospel Hospital

    Busan, South Korea

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • NEXT Oncology

    Fairfax, Virginia, 22031, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • National Cancer Center

    Seoul, 03080, South Korea

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Cancer Centre

    Taipei, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • National Taiwan University Hospital Hsin-Chu Branch

    Zhubei, 302058, Taiwan

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • Newcastle upon Tyne Hospital (NHS)

    Newcastle, United Kingdom

  • Oncopole Claudius Regaud, IUCT-Oncopole

    Toulouse, France

  • Piedmont Physicians Medical Oncology

    Atlanta, Georgia, 30318, United States

  • Queen Elizabeth Hospital

    Adelaide, South Australia, 5000, Australia

  • START Barcelona-HM CIOCC Early Phase Program

    Barcelona, Spain

  • START Centro Integral Oncologico Calra Campal

    Madrid, Spain

  • START Madrid-FJD, Hospital Fundación Jiménez Díaz

    Madrid, Spain

  • Samsung Medical Center

    Seoul, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    Seoul, MA, 01886, South Korea

  • Severance Hospital

    Seoul, South Korea

  • St. Vincent Hospital

    Suwon, South Korea

  • Taichung Veterans General Hospital

    Taichung, MA, 01886, Taiwan

  • Taipei Medical University Hospital

    Taipei, 110301, Taiwan

  • UCLA

    Los Angeles, California, 90095, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA, United Kingdom

  • University of California San Diego

    La Jolla, California, 92037, United States

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

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