Trials
Search / Trial NCT05652868

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 January 21, 2025

Recruiting

Keywords

C Met Mytx 011 Mythic Met Mytx011 Adc Kis Met 01

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.

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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