Open Actively Recruiting

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

About

Brief 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). MYTX-011 is composed of a pH-dependent anti-cMET antibody and the potent antimicrotubule drug monomethyl auristatin E (MMAE).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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: 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

Exclusion Criteria:

  • 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

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Study Stats
Protocol No.
23-001072
Category
Lung Cancer
Contact
Jenny Choi
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT05652868
For detailed technical eligibility, visit ClinicalTrials.gov.