A Phase 1 Multi-center Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects with Non-Small Cell Lung Cancer
The Phase 1 KisMET-01 clinical trial is a first-in-human, open-label, multi-center dose escalation and dose expansion study evaluating the safety, tolerability, pharmacokinetics and preliminary effectiveness of MYTX-011 in patients with locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC).
The study will be conducted in two parts. Part 1 will assess the safety and tolerability of MYTX-011 and identify the dose(s) to be studied in Part 2. Part 2 will include subjects with NSCLC with cMET overexpression or MET amplification/exon 14 skipping changes, which are currently populations with an unmet medical need.
Additional information about the KisMET-01 clinical trial, including eligibility criteria and more, can be found on clinicaltrials.gov (identifier: NCT05652868).
If you are a physician interested in more information, please contact: Clinicalsupport@mythictx.com.
cMET-targeting antibody-drug conjugate (ADC)
MYTX-011 was designed using Mythic’s FateControl™ platform by introducing an optimized set of changes into an anti-cMET antibody. This engineering is intended to allow MYTX-011 to boost cMET-dependent uptake and increase delivery of a potent chemotherapy inside cancer cells while reducing uptake in healthy cells.
MYTX-011 is an investigational agent that has not yet been approved by the U.S. Food and Drug Administration (FDA)
About cMET overexpression1,2
The cMET signaling pathway regulates important cellular processes and is overexpressed in many tumors.
While a small fraction of NSCLC tumors are dependent on cMET signaling activity, a much broader patient population overexpresses cMET and have the potential to be treated using a cMET ADC such as MYTX-011.
1Lee YJ, Han JY, Lee GK, et al. C-MET overexpression as a resistance biomarker to epidermal growth factor receptor tyrosine kinase inhibitors in EGFR-mutant non-small cell lung cancer. J ClinOnc. 2016;34:15_suppl, e20660-e20660.
2Lim EH, Zhang SL, Li JL, et al. Using whole genome amplification (WGA) of low-volume biopsies to assess the prognostic role of EGFR, KRAS, p53, and CMET mutations in advanced-stage non-small cell lung cancer (NSCLC). J Thorac Oncol. 2009;4(1):12-21.
Transforming ADC delivery by engineering the first self-navigating ADCs.
Our breakthrough technological approach is designed to improve efficacy across a broad set of molecular targets and patient profiles by allowing ADCs to actively navigate inside of cells, increasing delivery of anti-cancer agents to tumor cells with less impact on healthy cells.
This technology has the potential to expand the use of ADCs to patients who do not have other targeted therapeutic options.
We are rapidly advancing our lead ADC program, MYTX-011, and a pipeline of novel ADCs, demonstrating the potential of our FateControl™ technology.