Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer
Launched by MYTHIC THERAPEUTICS · Dec 7, 2022
Trial Information
Current as of February 05, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called MYTX-011 for patients with non-small cell lung cancer (NSCLC), a common type of lung cancer. The goal of the trial is to understand how safe and effective this drug is for people with advanced stages of NSCLC who have already tried other treatments. MYTX-011 works by targeting cancer cells and delivering a powerful drug directly to them, which may help fight the cancer more effectively.
To participate in the trial, patients need to have confirmed advanced NSCLC and have received standard treatment options. There are specific criteria based on the type of NSCLC and certain tumor characteristics that will determine eligibility. Participants can expect to receive the investigational drug and will be monitored closely for any side effects or reactions. The trial is currently recruiting patients, and it is important for those interested to discuss with their doctor whether this study might be a good option for them.
Gender
ALL
Eligibility 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 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 overexpression by IHC confirmed by central laboratory testing.
- Cohort D:
- • 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
- • that does not meet cMET IHC entry criteria for Cohorts A,B, or B2-C
- Cohort E:
- • - curative therapy), or metastatic NSCLC with actionable EGFR mutations
- • Tumor sample with high or intermediate cMETet expression tumor biopsy confirmed centrally
- • Must have received an available standard of care therapy and have progressed on at least 1 line of prior 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 cMEet expression tumor biopsy confirmed centrally
- • Must have received an available standard of care therapy and have progressed on at least 1 line of prior therapy in the locally advanced/metastatic setting.
- • Part 2 Cohorts A-D
- • 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
- • 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
Trial Officials
Ting Wu, MD MSc
Study Director
Mythic Therapeutics
About Mythic Therapeutics
Mythic Therapeutics is a pioneering biopharmaceutical company focused on advancing innovative therapies for patients with cancer and other serious diseases. With a commitment to precision medicine, Mythic Therapeutics leverages cutting-edge research and development to create targeted treatments that address unmet medical needs. The company is dedicated to improving patient outcomes through its robust pipeline of clinical trials and collaborations with leading research institutions. By harnessing the power of advanced technologies and a deep understanding of disease mechanisms, Mythic Therapeutics aims to transform the landscape of therapeutic options and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Milwaukee, Wisconsin, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Los Angeles, California, United States
Pittsburgh, Pennsylvania, United States
Newport Beach, California, United States
Atlanta, Georgia, United States
La Jolla, California, United States
Charleston, South Carolina, United States
Blacktown, New South Wales, Australia
Taichung, , Taiwan
Tainan, , Taiwan
New York, New York, United States
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Glasgow, , United Kingdom
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Valencia, , Spain
Camperdown, New South Wales, Australia
Taichung City, , Taiwan
Morristown, New Jersey, United States
Madrid, , Spain
Omaha, Nebraska, United States
London, , United Kingdom
Taipei City, , Taiwan
Zaragoza, , Spain
Villejuif, , France
Suwon, , Korea, Republic Of
Saint Louis, Missouri, United States
Madrid, , Spain
Marseille, , France
Fairfax, Virginia, United States
Taipei City, , Taiwan
Adelaide, South Australia, Australia
Fairfax, Virginia, United States
Boston, Massachusetts, United States
Nashville, Tennessee, United States
Boston, Massachusetts, United States
Nashville, Tennessee, United States
Fairfax, Virginia, United States
Pittsburgh, Pennsylvania, United States
Milwaukee, Wisconsin, United States
Mineola, New York, United States
New York, New York, United States
Houston, Texas, United States
Omaha, Nebraska, United States
Charleston, South Carolina, United States
Camperdown, New South Wales, Australia
Rolling Meadows, Illinois, United States
Camperdown, New South Wales, Australia
Santa Monica, California, United States
Adelaide, South Australia, Australia
Blacktown, New South Wales, Australia
Morristown, New Jersey, United States
Adelaide, South Australia, Australia
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Oxford, , United Kingdom
Goyang, , Korea, Republic Of
Lyon, , France
Atlanta, Georgia, United States
Madrid, , Spain
London, , United Kingdom
London, , United Kingdom
Seattle, Washington, United States
Busan, , Korea, Republic Of
Incheon, , Korea, Republic Of
Zhubei, , Taiwan
Rolling Meadows, Illinois, United States
Adelaide, South Australia, Australia
Seongnam, , Korea, Republic Of
Seoul, , Korea, Republic Of
Newcastle, , United Kingdom
Bordeaux, , France
Nantes, , France
Paris, , France
Toulouse, , France
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Malaga, , Spain
Taipei City, , Taiwan
Taipei, , Taiwan
Oxford, , United Kingdom
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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