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

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: Cohort A:
• Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC.
• 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.
• 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.
• Tumor sample with cMET overexpression 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 NSCLC.
• Tumor sample that does not meet cMET IHC entry criteria for Cohorts A-C
• Known MET amplification or exon 14 skipping mutations respectively. Patients with MET exon 14 skipping mutations must have received MET TKI therapy if available and considered standard of care. Cohort E:
• Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic NSCLC.
• Evidence of cMET expression by IHC as documented in medical records.
• No more than 3 prior lines of systemic therapy including prior cMET targeted ADC or antibody. Part 2 Cohorts A-D

• No more than two prior lines of therapy in the locally advanced/metastatic setting. Part 2 Cohorts A-E:

• Known to not have an actionable EGFR mutation. Patients with or without other driver mutations are permitted to enroll.
• Patients without any actionable gene alteration: must have progressed on (or be considered ineligible for) standard of care therapy
• Patients with actionable gene alterations (other than EGFR) must have progressed on (or be considered ineligible for) or be intolerant to anti-cancer therapy targeting driver gene alterations and available standard of care therapy 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

• Radiation to the lung within 2 months prior to screening.
• Major surgery within 28 days of first dose of study drug administration.
• Untreated, uncontrolled CNS metastases.
• 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
• Neuropathy > Grade 1
• History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver disease.
• Active or chronic corneal disorder