Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer

NCT05652868 | Terminated Phase 1 FDA Drug

• 2 other identifiers: MYTX-011-01KisMET-01
• Study Type: interventional
• Target: 227
• Locations: 7 countries
• Sites: 55

Brief 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).

Conditions

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

Keywords

cMET; MYTX-011; Mythic; MET; MYTX011; ADC; KisMET-01

Outcome Measures

Primary Outcomes (2)

• Part 1: Number of patients with dose limiting toxicity (DLT)

  The dose limiting toxicities will be based on number and severity of treatment-related adverse events.

  Up to Day 21

• Part 2: Number of patients with tumor response

  The overall response rate will be based on number of complete responses and partial responses.

  2 years

Secondary Outcomes (8)

• Part 1: Pharmacokinetic (PK) parameter (Total ADC)

  24 months

• Part 1: Pharmacokinetic (PK) parameter (Total antibody)

  24 months

• Part 1: Pharmacokinetic (PK) parameter (Free MMAE)

  24 months

• Part 1: ADA

  24 months

• Part 1: ORR

  24 months

Study Arms (9)

Part 1 Dose Escalation

EXPERIMENTAL

Part 1 patients will receive MYTX-011.

Drug: MYTX-011

Part 2 Cohort A

EXPERIMENTAL

Part 2 Cohort A patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1.

Drug: MYTX-011

Part 2 Cohort B

EXPERIMENTAL

Part 2 Cohort B patients will receive MYTX-011 at the recommended phase 2 dose.

Drug: MYTX-011

Part 2 Cohort C

EXPERIMENTAL

Part 2 Cohort C patients will receive MYTX-011 at the recommended phase 2 dose.

Drug: MYTX-011

Part 2 Cohort D

EXPERIMENTAL

Part 2 Cohort D patients will receive MYTX-011 at the recommended phase 2 dose.

Drug: MYTX-011

Part 2 Cohort E

EXPERIMENTAL

Part 2 Cohort E patients will receive MYTX-011 at the recommended phase 2 dose.

Drug: MYTX-011

Part 2 Cohort B2

EXPERIMENTAL

Part 2 Cohort B2 patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1

Drug: MYTX-011

Part 2 Cohort E2

EXPERIMENTAL

Part 2 Cohort E2 patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1

Drug: MYTX-011

Part 2 Cohort F

EXPERIMENTAL

Part 2 Cohort F patients will receive MYTX-011 at the recommended phase 2 dose.

Drug: MYTX-011

Interventions

MYTX-011 DRUG

MYTX-011 will be administered as an intravenous infusion every 21 days.

Part 1 Dose Escalation; Part 2 Cohort A; Part 2 Cohort B; Part 2 Cohort B2; Part 2 Cohort C; Part 2 Cohort D; Part 2 Cohort E; Part 2 Cohort E2; Part 2 Cohort F

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Mythic Therapeutics: lead

Study Sites (55)

University of California San Diego

La Jolla, California, 92037, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Piedmont Physicians Medical Oncology

Atlanta, Georgia, 30318, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MUSC Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

NEXT Oncology

Fairfax, Virginia, 22031, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98019, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Queen Elizabeth Hospital

Adelaide, South Australia, 5000, Australia

Location

Cancer Research SA

Adelaide, South Australia, 5011, Australia

Location

Institut Bergonié-Bordeaux

Bordeaux, France

Location

Centre Léon Bérard - Lyon

Lyon, France

Location

APHM - Hopital de la Timone

Marseille, France

Location

Institut de Cancérologie de l'Ouest (ICO institute)-St Herblain

Nantes, France

Location

INSTITUT Curie (lead)

Paris, France

Location

Oncopole Claudius Regaud, IUCT-Oncopole

Toulouse, France

Location

Gustave Roussy Institute

Villejuif, France

Location

Seoul National University Hospital

Seoul, MA, 01886, South Korea

Location

Kosin Univ. Gospel Hospital

Busan, South Korea

Location

Chungbuk National Univ. Hospital

Incheon, 21565, South Korea

Location

Gachon University

Seongnam, South Korea

Location

National Cancer Center

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

St. Vincent Hospital

Suwon, South Korea

Location

Instituto Oncológico Dr Rosell (IOR) - Hospital Univ. Dexeus

Barcelona, Spain

Location

START Barcelona-HM CIOCC Early Phase Program

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

START Centro Integral Oncologico Calra Campal

Madrid, Spain

Location

START Madrid-FJD, Hospital Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Quirónsalud Málaga

Málaga, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Spain

Location

Hospital Universitario Lozano Blesa

Zaragoza, Spain

Location

Taichung Veterans General Hospital

Taichung, MA, 01886, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110301, Taiwan

Location

National Taiwan University Cancer Centre

Taipei, Taiwan

Location

National Taiwan University Hospital Hsin-Chu Branch

Zhubei, 302058, Taiwan

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, W1T 7HA, United Kingdom

Location

Newcastle upon Tyne Hospital (NHS)

Newcastle, United Kingdom

Location

Churchill Hospital - Oxford University Hospitals

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (1)

• Gera N, Fitzgerald KM, Ramesh V, Patel P, Kanojia D, Colombo F, Kien L, Aoyama S, Xu L, Jean J, Deshpande AM, Comb WC, Chittenden T, Fiske BP. MYTX-011: A pH-Dependent Anti-c-MET Antibody-Drug Conjugate Designed for Enhanced Payload Delivery to c-MET-Expressing Tumor Cells. Mol Cancer Ther. 2024 Sep 4;23(9):1282-1293. doi: 10.1158/1535-7163.MCT-23-0784.

  PMID: 38684230 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ting Wu, MD MSc

  Mythic Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 15, 2022
• Study Start: March 23, 2023
• Primary Completion: October 31, 2025
• Study Completion: November 7, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: At the conclusion of the study

Locations

KR (8); US (17); AU (4); TW (6); FR (7); ES (9); GB (4)