NCT05652868

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

A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer - KisMET-01

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Mythic Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	MYTX-011	MYTX-011 will be administered as an intravenous infusion every 21 days.

Timeline

• Start date: 2023-03-23
• Primary completion: 2025-10-31
• Completion: 2025-11-07
• First posted: 2022-12-15
• Last updated: 2025-12-16

Locations

55 sites across 7 countries: United States, Australia, France, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study