Part 2 Cohort B for Non-small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MYTX-011-01 Clinical Site, Boston, MANon-small Cell Lung Cancer+4 MoreMYTX-011 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer (Stage IV)
  • Non-small Cell Lung Cancer Stage IIIB
  • Squamous Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 2 years

2 years
Part 1: DOR, TTR, DCR
Part 2: Number of patients with tumor response
24 months
Part 1: ADA
Part 1: ORR
Part 1: Pharmacokinetic (PK) parameter
Up to Day 21
Part 1: Number of patients with dose limiting toxicity (DLT)
Year 2
Part 1: OS
Part 1: PFS

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

Part 2 Cohort B
1 of 6
Part 2 Cohort D
1 of 6
Part 2 Cohort C
1 of 6
Part 2 Cohort E
1 of 6
Part 1 Dose Escalation
1 of 6
Part 2 Cohort A
1 of 6

Experimental Treatment

150 Total Participants · 6 Treatment Groups

Primary Treatment: Part 2 Cohort B · No Placebo Group · Phase 1

Part 2 Cohort B
Drug
Experimental Group · 1 Intervention: MYTX-011 · Intervention Types: Drug
Part 2 Cohort D
Drug
Experimental Group · 1 Intervention: MYTX-011 · Intervention Types: Drug
Part 2 Cohort C
Drug
Experimental Group · 1 Intervention: MYTX-011 · Intervention Types: Drug
Part 2 Cohort E
Drug
Experimental Group · 1 Intervention: MYTX-011 · Intervention Types: Drug
Part 1 Dose Escalation
Drug
Experimental Group · 1 Intervention: MYTX-011 · Intervention Types: Drug
Part 2 Cohort A
Drug
Experimental Group · 1 Intervention: MYTX-011 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Mythic TherapeuticsLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You don't have a specific type of gene mutation that can be treated with approved medication for this trial. If you don't have any actionable gene alterations, you must have already tried and not responded to standard treatment. If you do have other gene alterations, you must have already tried and not responded to standard treatment and medication that targets those specific gene alterations.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.