Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer
a study on Non-Small Cell Lung Cancer Lung Cancer Lung Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA UCSD
- Dates
- study startedcompletion around
- Principal Investigator
- by Jonathan Goldman, MD (ucla)

Description
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).
Official Title
A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer - KisMET-01
Details
The study will be conducted in 2 parts. Part 1 will assess the safety and tolerability of MYTX-011 and identify the dose to be studied in Part 2. Part 2 will include subjects with NSCLC with cMET overexpression or MET amplification/exon 14 skipping mutations, populations with a current unmet medical need.
Keywords
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, cMET, MYTX-011, Mythic, MET, MYTX011, ADC, KisMET-01, Lung Neoplasms, Non-Small-Cell Lung Carcinoma
Eligibility
You can join if…
Open to people ages 18 years and up
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/
You CAN'T join if...
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:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous or adenosquamous NSCLC without EGFR mutation.
- Tumor sample with low cMET expression on tumor biopsy confirmed centrally by IHC that does not meet inclusion criteria for Cohorts A, B, or B2.
Cohort E:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for a curative therapy), or metastatic NSCLC with actionable EGFR mutations.
- Tumor sample with high or intermediate cMET expression by IHC confirmed by central laboratory testing.
- Must have received an available standard of care therapy and have progressed on at least 1 and no more than 3 lines of prior systemic therapy in the locally advanced/metastatic setting.
Cohort E2
- Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic NSCLC with actionable EGFR mutations.
- Tumor sample with high or intermediate cMET expression by IHC confirmed by central laboratory testing.
- Must have received an available standard of care therapy and have progressed on at least 1 line and no more than 3 lines of prior systemic therapy in the locally advanced/metastatic setting.
Cohort F
- Have histologically or cytologically confirmed locally advanced non-squamous or adenosquamous NSCLC without EGFR mutation.
- Have ultra-low cMET expression on tumor biopsy confirmed centrally by IHC that does not meet inclusion criteria for Cohorts A,B, B2, or D.
All patients (Part 1 and Part 2)
Inclusion Criteria:
- 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 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
Locations
- University of California San Diego
accepting new patients
La Jolla California 92037 United States - UCLA
accepting new patients
Los Angeles California 90095 United States - Hoag Memorial Hospital Presbyterian
not yet accepting patients
Newport Beach California 92663 United States
Lead Scientist at University of California Health
- Jonathan Goldman, MD (ucla)
Hs Clinical Professor, Medicine. Authored (or co-authored) 117 research publications
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Mythic Therapeutics
- ID
- NCT05652868
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 250 study participants
- Last Updated