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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).

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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.

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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.

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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

TREATMENT

Phase

PHASE1

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

Condition: NSCLC, Non-Small Cell Lung Cancer and more
DRUG: MYTX-011
Blacktown, New South Wales, Australia and more
Sponsor: Mythic Therapeutics

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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

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/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.
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 Measure	Primary Outcome Description	Primary 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 response	The overall response rate will be based on number of complete responses and partial responses.	2 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Part 1: Pharmacokinetic (PK) parameter (Total ADC)	Total ADC	24 months
Part 1: Pharmacokinetic (PK) parameter (Total antibody)	Total antibody	24 months
Part 1: Pharmacokinetic (PK) parameter (Free MMAE)	Free MMAE	24 months
Part 1: ADA	Presence of anti-drug antibodies	24 months
Part 1: ORR	Complete response + partial response	24 months
Part 1: DOR, TTR, DCR	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	Progression free survival	for up to 2 years after end of treatment
Part 1: OS	Overall survival	for up to 2 years after end of treatment

Frequently Asked Questions

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References

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