What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) that are similar to MYTX-011, an antibody-drug conjugate targeting the cMET receptor with monomethyl auristatin E (MMAE), often cause side effects such as fatigue, nausea, peripheral neuropathy, and hematologic toxicities like neutropenia and anemia. Microtubule inhibitors, including MMAE, are particularly known for causing neuropathy, myelosuppression, and gastrointestinal disturbances.

What prior FDA approvals exist?

FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include various targeted therapies and immunotherapies. While specific ADCs targeting the cMET receptor like MYTX-011 are still under investigation, other ADCs and targeted therapies have been approved. For instance, pembrolizumab and atezolizumab are immunotherapies approved for NSCLC without EGFR mutations or ALK translocations. Additionally, targeted therapies such as entrectinib and larotrectinib have been approved for NTRK gene fusion-positive NSCLC. These treatments highlight the evolving landscape of NSCLC therapy, focusing on precision medicine and targeted approaches.

What other types of research exist?

Promising alternatives to MYTX-011 for NSCLC patients include: 1) Capmatinib and Tepotinib, which are MET inhibitors approved for MET exon-14-skipping mutations; 2) Rovalpituzumab tesirine, an ADC targeting DLL3, which may be effective in certain molecular subgroups of lung cancer; 3) UA62784, a potent microtubule polymerization inhibitor, though primarily studied in pancreatic cancer, it shows potential for broader applications.

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Antibody-Drug Conjugate

MYTX-011 for Lung Cancer

Phase 1

Recruiting

Research Sponsored by Mythic Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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.

Must not have

Radiation to the lung within 2 months prior to screening.

Major surgery within 28 days of first dose of study drug administration.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing MYTX-011, a new medication that targets advanced lung cancer cells with specific genetic markers. It uses an antibody to guide a powerful drug directly to the cancer cells to kill them.

Who is the study for?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have tried standard treatments. They must have measurable tumors, acceptable organ function, and agree to use birth control. People can't join if they've had recent major surgery, untreated brain metastases, significant liver disease, active infections needing IV treatment, or certain lung conditions.

What is being tested?

The study tests MYTX-011, an antibody-drug conjugate targeting cMET in NSCLC. It's given to see how safe it is and how well it works at different stages of the disease based on prior treatments and tumor characteristics like cMET expression levels.

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells while targeting cancer cells; nerve damage; issues from drug infusion; and complications from affecting non-cancerous dividing cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced lung cancer has been confirmed and I've tried all standard treatments.

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My non-squamous NSCLC is advanced, recurrent, or metastatic with high cMET expression.

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My non-squamous NSCLC is advanced, recurrent, or metastatic with confirmed cMET expression.

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My squamous NSCLC is advanced, recurrent, or metastatic with high cMET levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had lung radiation in the last 2 months.

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I have not had major surgery in the last 4 weeks.

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I have brain metastases that haven't been treated.

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I am currently on IV medication for an infection.

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My neuropathy is mild or I don't have it.

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I have a history of serious liver conditions.

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I have an ongoing eye condition affecting my cornea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Number of patients with dose limiting toxicity (DLT)

Part 2: Number of patients with tumor response

Secondary study objectives

Part 1: ADA

Part 1: DOR, TTR, DCR

Part 1: ORR

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part 2 Cohort E2Experimental Treatment1 Intervention

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

Group II: Part 2 Cohort EExperimental Treatment1 Intervention

Part 2 Cohort E patients will receive MYTX-011 at the recommended phase 2 dose.

Group III: Part 2 Cohort DExperimental Treatment1 Intervention

Part 2 Cohort D patients will receive MYTX-011 at the recommended phase 2 dose.

Group IV: Part 2 Cohort CExperimental Treatment1 Intervention

Part 2 Cohort C patients will receive MYTX-011 at the recommended phase 2 dose.

Group V: Part 2 Cohort B2Experimental Treatment1 Intervention

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

Group VI: Part 2 Cohort BExperimental Treatment1 Intervention

Part 2 Cohort B patients will receive MYTX-011 at the recommended phase 2 dose.

Group VII: Part 2 Cohort AExperimental Treatment1 Intervention

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.

Group VIII: Part 1 Dose EscalationExperimental Treatment1 Intervention

Part 1 patients will receive MYTX-011.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and antibody-drug conjugates (ADCs). Targeted therapies, such as EGFR and ALK inhibitors, block specific proteins that promote cancer growth. Immunotherapies, like PD-1/PD-L1 inhibitors, boost the immune system's ability to detect and kill cancer cells. ADCs, such as MYTX-011, combine an antibody targeting a specific receptor (e.g., cMET) with a cytotoxic drug (e.g., monomethyl auristatin E) to deliver the drug directly to cancer cells, reducing harm to normal cells. These treatments are significant for NSCLC patients as they provide more personalized and potentially more effective options with fewer side effects than traditional chemotherapy.

Emerging therapeutic agents for lung cancer.