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NSCLCPhase 1NCT05652868

Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer

A Phase 1 study testing MYTX-011 in people with NSCLC and NSCLC Stage IV, run by Mythic Therapeutics at 55 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase I open label multi-center study to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of the investigational drug MYTX-011 in patients with locally advanced, recurrent or metastatic NSCLC. MYTX-011 is in a class of medications called antibody drug conjugates (ADCs). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, NSCLC Stage IV, NSCLC Stage IIIB
What is being tested?
MYTX-011
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
227 participants
Where
55 sitesin 7 countries
Study dates
23 Mar 2023to 7 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Known to not have an actionable EGFR mutation. Subjects with or without other driver mutations are permitted to enroll.
  • Must have received (or be ineligible for) available standard of care therapy.
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  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

55 sites in 7 countries.

55 sites in 7 countries

United States17 sites

  • Piedmont Physicians Medical Oncology

    Atlanta, Georgia, 30318

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425

  • NEXT Oncology

    Fairfax, Virginia, 22031

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California San Diego

    La Jolla, California, 92037

  • UCLA

    Los Angeles, California, 90095

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Atlantic Health System

    Morristown, New Jersey, 07960

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • NYU Langone Medical Center

    New York, New York, 10016

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98019

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

Other trials in United States

Spain9 sites

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

    Barcelona

  • START Barcelona-HM CIOCC Early Phase Program

    Barcelona

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Ramón y Cajal

    Madrid

  • START Centro Integral Oncologico Calra Campal

    Madrid

  • START Madrid-FJD, Hospital Fundación Jiménez Díaz

    Madrid

  • Hospital Quirónsalud Málaga

    Málaga

  • Hospital Clinico Universitario de Valencia

    Valencia

  • Hospital Universitario Lozano Blesa

    Zaragoza

Other trials in Spain

South Korea8 sites

  • Kosin Univ. Gospel Hospital

    Busan

  • Chungbuk National Univ. Hospital

    Incheon, 21565

  • Gachon University

    Seongnam

  • Seoul National University Hospital

    Seoul, MA, 01886

  • National Cancer Center

    Seoul, 03080

  • Samsung Medical Center

    Seoul

  • Severance Hospital

    Seoul

  • St. Vincent Hospital

    Suwon

Other trials in South Korea

France7 sites

  • Institut Bergonié-Bordeaux

    Bordeaux

  • Centre Léon Bérard - Lyon

    Lyon

  • APHM - Hopital de la Timone

    Marseille

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

    Nantes

  • INSTITUT Curie (lead)

    Paris

  • Oncopole Claudius Regaud, IUCT-Oncopole

    Toulouse

  • Gustave Roussy Institute

    Villejuif

Other trials in France

Taiwan6 sites

  • Taichung Veterans General Hospital

    Taichung, MA, 01886

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Medical University Hospital

    Taipei, 110301

  • National Taiwan University Cancer Centre

    Taipei

  • National Taiwan University Hospital Hsin-Chu Branch

    Zhubei, 302058

Other trials in Taiwan

Australia4 sites

  • Queen Elizabeth Hospital

    Adelaide, South Australia, 5000

  • Cancer Research SA

    Adelaide, South Australia, 5011

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

Other trials in Australia

United Kingdom4 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA

  • Newcastle upon Tyne Hospital (NHS)

    Newcastle

  • Churchill Hospital - Oxford University Hospitals

    Oxford, OX3 7LJ

Other trials in United Kingdom

About this study

Official title: A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer - KisMET-01

This is a Phase I open label multi-center study to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of the investigational drug MYTX-011 in patients with locally advanced, recurrent or metastatic NSCLC. MYTX-011 is in a class of medications called antibody drug conjugates (ADCs). MYTX-011 is composed of a pH-dependent anti-cMET antibody and the potent antimicrotubule drug monomethyl auristatin E (MMAE).

Read the detailed description

The study will be conducted in 2 parts. Part 1 will assess the safety and tolerability of MYTX-011 and identify the dose to be studied in Part 2. Part 2 will include subjects with NSCLC with cMET overexpression or MET amplification/exon 14 skipping mutations, populations with a current unmet medical need.

Being tested
MYTX-011
Keywords
cMET, MYTX-011, Mythic, MET, MYTX011, ADC, KisMET-01
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MYTX-011Drug

    MYTX-011 will be administered as an intravenous infusion every 21 days.

Study groups in NCT05652868
Study groupRoleWhat they receive
Part 1 Dose EscalationExperimentalPart 1 patients will receive MYTX-011.
Receives: Drug: MYTX-011
Part 2 Cohort AExperimentalPart 2 Cohort A patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1.
Receives: Drug: MYTX-011
Part 2 Cohort BExperimentalPart 2 Cohort B patients will receive MYTX-011 at the recommended phase 2 dose.
Receives: Drug: MYTX-011
Part 2 Cohort CExperimentalPart 2 Cohort C patients will receive MYTX-011 at the recommended phase 2 dose.
Receives: Drug: MYTX-011
Part 2 Cohort DExperimentalPart 2 Cohort D patients will receive MYTX-011 at the recommended phase 2 dose.
Receives: Drug: MYTX-011
Part 2 Cohort EExperimentalPart 2 Cohort E patients will receive MYTX-011 at the recommended phase 2 dose.
Receives: Drug: MYTX-011
Part 2 Cohort B2ExperimentalPart 2 Cohort B2 patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1
Receives: Drug: MYTX-011
Part 2 Cohort E2ExperimentalPart 2 Cohort E2 patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1
Receives: Drug: MYTX-011
Part 2 Cohort FExperimentalPart 2 Cohort F patients will receive MYTX-011 at the recommended phase 2 dose.
Receives: Drug: MYTX-011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of patients with dose limiting toxicity (DLT)

    The dose limiting toxicities will be based on number and severity of treatment-related adverse events.

    Measured: Up to Day 21

  2. Part 2: Number of patients with tumor response

    The overall response rate will be based on number of complete responses and partial responses.

    Measured: 2 years

Secondary outcomes (8)

  1. Part 1: Pharmacokinetic (PK) parameter (Total ADC)

    Total ADC

    Measured: 24 months

  2. Part 1: Pharmacokinetic (PK) parameter (Total antibody)

    Total antibody

    Measured: 24 months

  3. Part 1: Pharmacokinetic (PK) parameter (Free MMAE)

    Free MMAE

    Measured: 24 months

  4. Part 1: ADA

    Presence of anti-drug antibodies

    Measured: 24 months

  5. Part 1: ORR

    Complete response + partial response

    Measured: 24 months

  6. Part 1: DOR, TTR, DCR

    Duration of response in patients that achieve CR or PR, time to response, best overall response and disease control rate

    Measured: 2 years

  7. Part 1: PFS

    Progression free survival

    Measured: for up to 2 years after end of treatment

  8. Part 1: OS

    Overall survival

    Measured: for up to 2 years after end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2022
  2. Study start23 Mar 2023
  3. Primary completion31 Oct 2025
  4. Study completion7 Nov 2025

Why it stopped: Business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05652868
Sponsor's protocol ID
MYTX-011-01
Other IDs
KisMET-01
Status last verified
Nov 2025
First submitted
29 Nov 2022
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Gera N, Fitzgerald KM, Ramesh V, Patel P, Kanojia D, Colombo F, Kien L, Aoyama S, Xu L, Jean J, Deshpande AM, Comb WC, Chittenden T, Fiske BP. MYTX-011: A pH-Dependent Anti-c-MET Antibody-Drug Conjugate Designed for Enhanced Payload Delivery to c-MET-Expressing Tumor Cells. Mol Cancer Ther. 2024 Sep 4;23(9):1282-1293. doi: 10.1158/1535-7163.MCT-23-0784.

    PubMed 38684230

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MYTX-011 in people with NSCLC and NSCLC Stage IV, run by Mythic Therapeutics at 55 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 43 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Spain, South Korea, France, Taiwan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of patients with dose limiting toxicity (DLT) (time frame: Up to Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05652868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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