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

M

Mythic Therapeutics

Status and phase

Enrolling
Phase 1

Conditions

Advanced Non-Small Cell Squamous Lung Cancer
NSCLC Stage IV
Advanced Non-Small Cell Non-Squamous Lung Cancer
Advanced Non-Small Cell Lung Cancer
NSCLC Stage IIIB
Non-Small Cell Lung Cancer
NSCLC

Treatments

Drug: MYTX-011

Study type

Interventional

Funder types

Industry

Identifiers

NCT05652868
KisMET-01 (Other Identifier)
MYTX-011-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

150 participants in 6 patient groups

Part 1 Dose Escalation
Experimental group
Description:
Part 1 patients will receive MYTX-011.
Treatment:
Drug: MYTX-011
Part 2 Cohort A
Experimental group
Description:
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.
Treatment:
Drug: MYTX-011
Part 2 Cohort B
Experimental group
Description:
Part 2 Cohort B patients will receive MYTX-011 at the recommended phase 2 dose.
Treatment:
Drug: MYTX-011
Part 2 Cohort C
Experimental group
Description:
Part 2 Cohort C patients will receive MYTX-011 at the recommended phase 2 dose.
Treatment:
Drug: MYTX-011
Part 2 Cohort D
Experimental group
Description:
Part 2 Cohort D patients will receive MYTX-011 at the recommended phase 2 dose.
Treatment:
Drug: MYTX-011
Part 2 Cohort E
Experimental group
Description:
Part 2 Cohort E patients will receive MYTX-011 at the recommended phase 2 dose.
Treatment:
Drug: MYTX-011

Trial contacts and locations

56

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Central trial contact

Lisa Haystrand, MSc; William T Downing

Data sourced from clinicaltrials.gov

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