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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05652868
Recruitment Status : Recruiting
First Posted : December 15, 2022
Last Update Posted : May 26, 2023
Sponsor:
Information provided by (Responsible Party):
Mythic Therapeutics

Study Description
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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).

Condition or disease Intervention/treatment Phase
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 Drug: MYTX-011 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 23, 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 for up to two years.
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 for up to two years.
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 for up to two years.
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 for up to two years.
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 for up to two years.
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 for up to two years.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Part 1: Pharmacokinetic (PK) parameter [ Time Frame: 24 months ]
    Total ADC

  2. Part 1: Pharmacokinetic (PK) parameter [ Time Frame: 24 months ]
    Total antibody

  3. Part 1: Pharmacokinetic (PK) parameter [ Time Frame: 24 months ]
    Free MMAE

  4. Part 1: ADA [ Time Frame: 24 months ]
    Presence of anti-drug antibodies

  5. Part 1: ORR [ Time Frame: 24 months ]
    Complete response + partial response

  6. 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

  7. Part 1: PFS [ Time Frame: for up to 2 years after end of treatment ]
    Progression free survival

  8. Part 1: OS [ Time Frame: for up to 2 years after end of treatment ]
    Overall survival


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05652868


Contacts
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Contact: Helen Chalk, BSc 1-833-888-1138 clinicalsupport@mythictx.com
Contact: Lisa Haystrand, MS 1-833-888-1138 clinicalsupport@mythictx.com

Locations
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United States, Massachusetts
KisMET-01 Clinical Site Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lisa Haystrand    833-888-1138    clinicalsupport@mythictx.com   
United States, Tennessee
KisMET-01 Clinical Site Recruiting
Nashville, Tennessee, United States, 37203
Contact: Lisa Haystrand    833-888-1138    clinicalsupport@mythictx.com   
United States, Virginia
KisMET-01 Clinical Site Recruiting
Fairfax, Virginia, United States, 22031
Contact: Lisa Haystrand, MS    833-888-1138    clinicalsupport@mythictx.com   
Sponsors and Collaborators
Mythic Therapeutics
More Information
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Responsible Party: Mythic Therapeutics
ClinicalTrials.gov Identifier: NCT05652868    
Other Study ID Numbers: MYTX-011-01
KisMET-01 ( Other Identifier: Mythic Therapeutics )
First Posted: December 15, 2022    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mythic Therapeutics:
cMET
MYTX-011
Mythic
MET
 MYTX011
ADC
KisMET-01
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms