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

Stopped early · Phase 1

Conditions studied: NSCLC, NSCLC Stage IV, NSCLC Stage IIIB, Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Advanced Non-Small Cell Lung Cancer, Advanced Non-Small Cell Non-Squamous Lung Cancer

In brief

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).

Key facts

Study ID

NCT05652868

Run by

Mythic Therapeutics

People needed

227

Starts

2023-03-23

Expected to finish

2025-11-07

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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:

You may not qualify if…

• 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 it is running

• UCLA — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Piedmont Physicians Medical Oncology — Atlanta, Georgia, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Atlantic Health System — Morristown, New Jersey, United States
• NYU Langone Medical Center — New York, New York, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• MUSC Hollings Cancer Center — Charleston, South Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Oncology — Fairfax, Virginia, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Blacktown Hospital — Blacktown, New South Wales, Australia
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
• Queen Elizabeth Hospital — Adelaide, South Australia, Australia
• Cancer Research SA — Adelaide, South Australia, Australia
• Institut Bergonié-Bordeaux — Bordeaux, France
• Centre Léon Bérard - Lyon — Lyon, France
• APHM - Hopital de la Timone — Marseille, France
• Institut de Cancérologie de l'Ouest (ICO institute)-St Herblain — Nantes, France
• University of California San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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