Share

Save

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

PHASE1RECRUITING

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).

info
Simpliy with AI

Study details:

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.

info
Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • 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.
  • Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC without EGFR mutation in Cohort A.
  • Tumor sample with high cMET expression by IHC confirmed by central laboratory testing in 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 in Cohort B.
  • Tumor sample with intermediate cMET expression by IHC confirmed by central laboratory testing in 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 in Cohort B2.
  • Tumor sample with intermediate cMET expression by IHC confirmed by central laboratory testing in Cohort B2.
  • Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic squamous NSCLC without EGFR mutation in Cohort C.
  • Tumor sample with cMET overexpression by IHC confirmed by central laboratory testing in Cohort C.
  • Have histologically or cytologically confirmed locally advanced non-squamous or adenosquamous NSCLC without EGFR mutation in Cohort D.
  • Tumor sample with low cMET expression on tumor biopsy confirmed centrally in Cohort D.
  • Have locally advanced, recurrent (and not a candidate for curative therapy), or metastatic NSCLC with actionable EGFR mutations in Cohort E.
  • Tumor sample with high or intermediate cMET expression tumor biopsy confirmed centrally in Cohort E.
  • Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic NSCLC with actionable EGFR mutations in Cohort E2.
  • Tumor sample with high or intermediate cMET expression tumor biopsy confirmed centrally in Cohort E2.
  • Known to not have an actionable EGFR mutation.
  • Must have received available standard of care therapy.
  • Must have progressed on at least 1 line of prior therapy in the locally advanced/metastatic setting.
  • 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.
  • Subjects with actionable gene alterations (other than EGFR) must have progressed on anticancer therapy targeting driver gene alterations and platinum-based chemotherapy.
  • Must have at least one measurable lesion per RECIST 1.1.
  • ECOG performance status 0 or 1.
  • 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 6 weeks prior to screening. For all other sites (except lung), therapeutic or palliative radiation within 2 weeks prior to the first dose of study drug.
  • Must have recovered from all radiation-related toxicity.
  • Major surgery within 28 days of first dose of study drug administration.
  • Untreated, uncontrolled central nervous system (CNS) metastases and/or leptomeningeal disease.
  • History of interstitial lung disease or pneumonitis that required treatment with systemic steroids or evidence of active interstitial lung disease or pneumonitis.
  • 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 within 14 Days of Cycle 1 Day 1.
  • Neuropathy > Grade 1.
  • History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver disease.
  • Active or chronic corneal disorder.
  • Conditions that may interfere with assessment of vision, such as monocular status or severe visual impairment in 1 or both eyes.
  • info
    Simplify with AI

    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-03-23

    Primary completion: 2025-12-01

    Study completion finish: 2027-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT05652868

    Intervention or treatment

    DRUG: MYTX-011

    Conditions

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

    Find a site

    Closest Location:

    Blacktown Hospital

    Research sites nearby

    Select from list below to view details:

    • Blacktown Hospital

      Blacktown, New South Wales, Australia

    • Chris O'Brien Lifehouse

      Camperdown, New South Wales, Australia

    • Queen Elizabeth Hospital

      Adelaide, South Australia, Australia

    • Cancer Research SA

      Adelaide, South Australia, Australia

    Loading...

    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?

    Participant Group/ArmIntervention/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.
    EXPERIMENTAL: Part 2 Cohort B2
    • 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
    • MYTX-011 will be administered as an intravenous infusion every 21 days.
    EXPERIMENTAL: Part 2 Cohort E2
    • 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
    • MYTX-011 will be administered as an intravenous infusion every 21 days.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    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 responseThe overall response rate will be based on number of complete responses and partial responses.2 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Part 1: Pharmacokinetic (PK) parameter (Total ADC)Total ADC24 months
    Part 1: Pharmacokinetic (PK) parameter (Total antibody)Total antibody24 months
    Part 1: Pharmacokinetic (PK) parameter (Free MMAE)Free MMAE24 months
    Part 1: ADAPresence of anti-drug antibodies24 months
    Part 1: ORRComplete response + partial response24 months
    Part 1: DOR, TTR, DCRDuration of response in patients that achieve CR or PR, time to response, best overall response and disease control rate2 years
    Part 1: PFSProgression free survivalfor up to 2 years after end of treatment
    Part 1: OSOverall survivalfor up to 2 years after end of treatment

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

    No questions submitted. Be the first to ask a question!

    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

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

    Other trails to consider

    Top searched conditions