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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial tests a new drug, MYTX-011, to treat advanced lung cancer. MYTX-011 is an antibody drug conjugate composed of an anti-cMET antibody and an antimicrotubule drug.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My non-squamous NSCLC is advanced, recurrent, or metastatic with confirmed cMET expression.
Select...
My squamous NSCLC is advanced, recurrent, or metastatic with high cMET levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Number of patients with dose limiting toxicity (DLT)
Part 2: Number of patients with tumor response
Secondary outcome measures
Part 1: ADA
Part 1: DOR, TTR, DCR
Part 1: ORR
+5 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Part 2 Cohort EExperimental Treatment1 Intervention
Part 2 Cohort E patients will receive MYTX-011 at the recommended phase 2 dose.
Group II: Part 2 Cohort DExperimental Treatment1 Intervention
Part 2 Cohort D patients will receive MYTX-011 at the recommended phase 2 dose.
Group III: Part 2 Cohort CExperimental Treatment1 Intervention
Part 2 Cohort C patients will receive MYTX-011 at the recommended phase 2 dose.
Group IV: Part 2 Cohort BExperimental Treatment1 Intervention
Part 2 Cohort B patients will receive MYTX-011 at the recommended phase 2 dose.
Group V: 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 VI: Part 1 Dose EscalationExperimental Treatment1 Intervention
Part 1 patients will receive MYTX-011.
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Who is running the clinical trial?
Mythic TherapeuticsLead Sponsor
Ting Wu, MD MScStudy DirectorMythic Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases that haven't been treated.My advanced lung cancer has been confirmed and I've tried all standard treatments.My cancer does not have treatable EGFR mutations but may have other mutations.My squamous NSCLC is advanced, recurrent, or metastatic with high cMET levels.My neuropathy is mild or I don't have it.I have had no more than two treatments for my advanced cancer.I have not had major surgery in the last 4 weeks.I have not had lung radiation in the last 2 months.My non-squamous NSCLC is advanced, recurrent, or metastatic with confirmed cMET expression.I have had lung inflammation treated with steroids, but lung scarring from past radiation is okay.My NSCLC is advanced, recurrent, or metastatic with cMET expression and I've had no more than 3 treatments.I have a history of serious liver conditions.I have an ongoing eye condition affecting my cornea.My advanced lung cancer does not qualify for earlier trial groups but has specific genetic changes.I do not have any major illnesses that could affect the study's safety or results.I am currently on IV medication for an infection.My non-squamous NSCLC is advanced, recurrent, or metastatic with high cMET expression.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Dose Escalation
- Group 2: Part 2 Cohort C
- Group 3: Part 2 Cohort D
- Group 4: Part 2 Cohort A
- Group 5: Part 2 Cohort E
- Group 6: Part 2 Cohort B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are enrolled in this experiment?
"Affirmative. The details hosted on the clinicaltrials.gov website indicate that this experiment is actively recruiting participants, with 150 individuals sought from a single site. This trial was first posted on March 1st 2023 and updated most recently on February 8th 2023."
Answered by AI
Has the FDA granted its blessing to Part 2 Cohort E?
"Our research team at Power judged the safety of Part 2 Cohort E to be a 1, as this is an early-phase trial which has not yet provided sufficient evidence regarding its efficacy and safety."
Answered by AI
Are there any openings remaining to join this research endeavor?
"Affirmative, information on clinicaltrials.gov attests to the fact that this medical trial is actively recruiting patients. The investigation was first made available on March 1st 2023 and has been recently updated on February 8th 2023. A total of 150 participants are needed from a single site."
Answered by AI
What therapeutic objectives have been identified for this clinical trial?
"This trial will evaluate the primary outcome, number of patients with tumor response, over a 21-day period. Secondary endpoints encompass anti-drug antibodies (ADA), duration of response in those that achieve complete or partial responses (DOR), time to response (TTR), disease control rate (DCR) and progression free survival (PFS)."
Answered by AI
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