Clinical Trials List
Protocol NumberMYTX-011-01
NCT Number(ClinicalTrials.gov Identfier)NCT05652868
Completed
2023-12-01 - 2027-12-31
Phase I
Recruiting6
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
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
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/06/22
Investigators and Locations
Co-Principal Investigator
- Jih-Hsiang Lee 無
- 許嘉林 無
- 廖斌志 無
- 吳尚俊 無
- 徐偉勛 無
- 廖唯昱 無
- 林昭文 無
- CHAO-CHI HO CHAO-CHI HO 無
- YEN-TING LIN 無
- James Chih-Hsin Yang 無
- 蔡子修 無
- 吳宗哲 無
- JIN-YUAN SHIH 無
- 楊景堯 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳尚俊 無
- 廖斌志 無
- James Chih-Hsin Yang 無
- YEN-TING LIN 無
- JIN-YUAN SHIH 無
- 林昭文 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chien-Chung Lin
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Non-Small Cell Lung Cancer
Objectives
Part 1: MYTX-011 Dosage Escalation
Primary Objectives
• To assess the safety and tolerability of MYTX-011
• To determine the RP2D and/or MTD of MYTX-011
Secondary Objectives
• To describe the PK characteristics of MYTX-011, including total ADC, total antibody, and free MMAE
• To determine the optimal biological dose of MYTX-011 in group A: based on safety, PK, and preliminary antitumor activity
• To assess the incidence and persistence of ADA against MYTX-011
• To determine the preliminary antitumor activity of MYTX-011
Exploratory Objectives
• To measure the degree of cMET expression in tumor tissue and the presence of changes in MET
• To evaluate biomarkers and predictors (e.g., molecular, genetic, protein) related to response to and resistance to MYTX-011 in tumors and blood
Part 2: MYTX-011 Dosage Extension (A to Group E)
Primary Objectives
• Group A: Advanced non-squamous NSCLC with high cMET expression and no functional EGFR mutation
• Group B: Advanced non-squamous NSCLC with intermediate cMET expression and no functional EGFR mutation
• Group C: Advanced squamous NSCLC with overexpression of cMET and no functional EGFR mutation
• Group D: Advanced squamous or non-squamous NSCLC with MET amplification or exon 14 skipping mutation and no functional EGFR mutation
• Group E: Advanced squamous or non-squamous NSCLC with cMET expression, no functional EGFR mutation, and prior cMET ADC or antibody therapy
Secondary Objectives
• To evaluate the safety and tolerability of MYTX-011
• To describe the PK characteristics of MYTX-011, including total ADC, total antibody, and free MMAE
• Description Antitumor Activity of MYTX-011
• To explore the optimal biological dose of MYTX-011 in group A
• To assess the incidence and persistence of ADA against MYTX-011
Exploratory Objectives
• To measure the degree of cMET expression in tumor tissues
• To assess biomarkers and predictors (e.g., molecular, genetic, protein) related to response to and resistance to MYTX-011 in tumors and blood
Test Drug
Injectable frozen powder
Active Ingredient
MYTX-011
Dosage Form
Vial for Injection
Dosage
100mg/10mL
Endpoints
• TEAE, incidence and severity of AEs, and clinically significant changes in vital signs, ECG, and laboratory parameters compared to baseline.
• RP2D will be selected as a bioactive dose equal to or lower than the MTD (or, if the MTD is not determined during the trial, the highest dose to be measured).
• MTD will be determined by DLT during cycle 1. The observation period for DLT is cycle 1.
• Each expanded cohort is based on the ORR (confirmed CR+PR) according to RECIST version 1.1.
• RP2D will be selected as a bioactive dose equal to or lower than the MTD (or, if the MTD is not determined during the trial, the highest dose to be measured).
• MTD will be determined by DLT during cycle 1. The observation period for DLT is cycle 1.
• Each expanded cohort is based on the ORR (confirmed CR+PR) according to RECIST version 1.1.
Inclution 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 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/exclusion criteria 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
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/exclusion criteria 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
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
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
The Estimated Number of Participants
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Taiwan
60 participants
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Global
300 participants
