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

April 2, 2024 updated by: Mythic Therapeutics

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in 2 parts. Part 1 will assess the safety and tolerability of MYTX-011 and identify the dose to be studied in Part 2. Part 2 will include subjects with NSCLC with cMET overexpression or MET amplification/exon 14 skipping mutations, populations with a current unmet medical need.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Dose Escalation
Part 1 patients will receive MYTX-011.
Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days.
Experimental: Part 2 Cohort A
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
MYTX-011 will be administered as an intravenous infusion every 21 days.
Experimental: Part 2 Cohort B
Part 2 Cohort B patients will receive MYTX-011 at the recommended phase 2 dose.
Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days.
Experimental: Part 2 Cohort C
Part 2 Cohort C patients will receive MYTX-011 at the recommended phase 2 dose.
Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days.
Experimental: Part 2 Cohort D
Part 2 Cohort D patients will receive MYTX-011 at the recommended phase 2 dose.
Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days.
Experimental: Part 2 Cohort E
Part 2 Cohort E patients will receive MYTX-011 at the recommended phase 2 dose.
Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of patients with dose limiting toxicity (DLT)
Time Frame: Up to Day 21
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
Time Frame: 2 years
The overall response rate will be based on number of complete responses and partial responses.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: ADA
Time Frame: 24 months
Presence of anti-drug antibodies
24 months
Part 1: ORR
Time Frame: 24 months
Complete response + partial response
24 months
Part 1: DOR, TTR, DCR
Time Frame: 2 years
Duration of response in patients that achieve CR or PR, time to response, best overall response and disease control rate
2 years
Part 1: PFS
Time Frame: for up to 2 years after end of treatment
Progression free survival
for up to 2 years after end of treatment
Part 1: OS
Time Frame: for up to 2 years after end of treatment
Overall survival
for up to 2 years after end of treatment
Part 1: Pharmacokinetic (PK) parameter (Total ADC)
Time Frame: 24 months
Total ADC
24 months
Part 1: Pharmacokinetic (PK) parameter (Total antibody)
Time Frame: 24 months
Total antibody
24 months
Part 1: Pharmacokinetic (PK) parameter (Free MMAE)
Time Frame: 24 months
Free MMAE
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mythic Therapeutics

Investigators

  • Study Director: Ting Wu, MD MSc, Mythic Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYTX-011-01
  • KisMET-01 (Other Identifier: Mythic Therapeutics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

At the conclusion of the study

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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