Clinical Trials List
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
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 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
- 吳尚俊 無
- 徐偉勛 無
- 廖唯昱 無
- 林昭文 無
- Jih-Hsiang Lee 無
- 許嘉林 無
- 廖斌志 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YEN-TING LIN 無
- JIN-YUAN SHIH 無
- 林昭文 無
- James Chih-Hsin Yang 無
- 吳尚俊 無
- 廖斌志 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
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
‧ RP2D will be selected as the biologically active dose at or below the MTD (or if the MTD is not determined during the trial, the highest dose tested)
‧ MTD will be determined by DLT during Cycle 1. The observation period for DLT is Cycle 1.
‧ ORR (confirmed CR+PR) of each expansion group based on RECIST version 1.1
Inclution 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
The Estimated Number of Participants
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Taiwan
60 participants
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Global
300 participants
