Home › Trials › NCT05652868

Evaluating MYTX-011 for Non-Small Cell Lung Cancer

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

Phase 1 Interventional Mythic Therapeutics · NCT05652868

This study is testing a new drug called MYTX-011 to see if it is safe and effective for people with advanced non-small cell lung cancer who have already tried other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorMythic Therapeutics Industry-sponsored
Drugs / interventionschemotherapy, Radiation
Locations55 sites (La Jolla, California and 54 other locations)
Trial IDNCT05652868 on ClinicalTrials.gov

What this trial studies

This Phase I open-label multi-center study aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of MYTX-011, an antibody-drug conjugate, in patients with advanced non-small cell lung cancer (NSCLC). The study is divided into two parts: the first part focuses on determining the appropriate dosage and safety profile, while the second part targets patients with specific genetic markers related to cMET overexpression or mutations. Participants must have previously received standard therapies and have progressed on at least one line of systemic treatment.

Who should consider this trial

Good fit: Ideal candidates include individuals with locally advanced, recurrent, or metastatic NSCLC who have received prior standard therapies and have specific genetic markers.

Not a fit: Patients with actionable EGFR mutations may not benefit from this study as they are excluded from participation.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced NSCLC who have limited treatment alternatives.

How similar studies have performed: Other studies involving antibody-drug conjugates have shown promise in treating various cancers, suggesting potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

La Jolla, California and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NSCLCNSCLC Stage IVNSCLC Stage IIIBNon-Small Cell Lung CancerAdvanced Non-Small Cell Squamous Lung CancerAdvanced Non-Small Cell Lung CancerAdvanced Non-Small Cell Non-Squamous Lung CancercMET
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.