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

Eligibility Criteria

• * 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.
• * 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.
• * 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.
• * 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.
• * 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 overexpression by IHC confirmed by central laboratory testing.
• * Have histologically or cytologically confirmed locally advanced non-squamous or adenosquamous NSCLC without EGFR mutation.
• * Tumor sample with low cMET expression on tumor biopsy confirmed centrally
• 1. Known to not have an actionable EGFR mutation. Subjects with or without other driver mutations are permitted to enroll.
• 2. Must have received available standard of care therapy.
• 3. Must have progressed on at least 1 line of prior therapy in the locally advanced/metastatic setting. Note: multiple lines of TKI for the same actionable mutation count as 1 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.
• 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).
• 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.
• 6. Subjects with actionable gene alterations (other than EGFR) 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
• * 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