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

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mythic Therapeutics

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:

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