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

Brief description of study

MYTX-011 is a cMET-targeted val-cit-monomethyl auristatin E (vcMMAE) antibody-drug conjugate (ADC) with a fully humanized immunoglobulin (Ig)G1. The drug-to-antibody ratio (DAR) for MYTX-011 is 2:1. MYTX-011 binds to cMET with high affinity and specificity. MYTX-011 has been engineered to have pH dependent binding, which results in higher internalization and payload delivery to cMET+ tumor cells. This is manifested as increased internalization in cMET+ tumor cells in vitro compared to a non-engineered parent ADC and greater in vivo efficacy in murine non-small cell lung cancer (NSCLC) cMET+ tumor xenograft models compared to reference cMET-targeting ADCs with higher DAR values. The linker/payload of MYTX-011 (vcMMAE) has been well-characterized non-clinically and/or clinically for several marketed monomethyl auristatin E (MMAE)-containing ADCs. The nonclinical and clinical toxicities of MMAE-containing ADCs also have been well described- in the literature (Fisher 2021; Saber et al, 2015). Preliminary safety and efficacy data from in vitro and in vivo nonclinical assessments of MYTX-011 further support development as a treatment for NSCLC in appropriately designed clinical research studies. 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


Clinical Study Identifier: s22-01456
ClinicalTrials.gov Identifier: NCT05652868
Principal Investigator: Elaine Shum.
Other Investigators: Vamsidhar Velcheti, Melissa L Martinez, Samantha VanMaanen, Elka R Travis, Anam Qureshi, Jessica Wang, Carol M Lee, Salman Rafi Punekar, Laura Palazzolo, Sally Lau, Gabrielle Fridman, Joshua K Sabari, Marissa Rybstein, David Mendoza, Nitish Mehta, James Newman, Jeffrey G Schneider, Avital Benson, Natalia Cherkassky, Jonathan B Kahn, Danny Perlaza.


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