The first patients have been dosed with MYTX-011, a c-MET-targeting antibody-drug conjugate (ADC), in the phase 1 KisMET-01 study of patients with locally-advanced, recurrent, or metastatic non–small cell lung cancer (NSCLC; NCT05652868).1
The patient was dosed at Sarah Cannon Research Institute at Tennessee Oncology in Nashville, Tennessee. This is one of 3 study sites that has begun recruitment for the KisMET-01 study. The other sites are in Massachusetts and Virginia.
About the Phase 1 KisMET-01 Study
Trial Name: 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
ClinicalTrials.gov Identifier: NCT05652868
Sponsor: Mythic Therapeutics
Recruitment Contact: Michelle Hylan or Lisa Haystrand, 1-833-888-1138, firstname.lastname@example.org
Completion Date: December 2027
The study follows an open-label multi-center, dose-escalation, and dose-expansion design in effort to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of MYTX-011 in advanced NSCLC. To carry out the investigation, study investigators will be looking at the coprimary end points of dose-limiting toxicity and tumor response, as well as secondary end points, including pharmacokinetics, presence of anti-drug antibodies, objective response rate, duration of response, progression-free survival, and overall survival.2
“Although ADCs have been around for decades, their clinical benefit has been limited to a subset of diseases and targets with specific characteristics, such as high levels of target expression,” said Melissa Johnson, MD, director, Lung Cancer Research, Sarah Cannon Research Institute, in a press release.1 “With cMET overexpression occurring in up to 70% of NSCLC tumors, patients need better treatment options to address lower levels of cMET target expression. We look forward to evaluating the potential of MYTX-011 to expand the use and eligibility of ADCs for patients with NSCLC.”
Approximately 150 patients with advanced NSCLC will be enrolled in the study. During part 1, the dose-escalation phase, treatment with MYTX-011 will be administered intravenously every 21 days for up to 2 years. During part 2, the dose expansion phase, patients will receive 2 different doses of the agent, following the same dosing schedule as part 1. Following the dose-expansion phase, patients will be administered the recommended phase 2 dose of MYTX-011.2
To be eligible for enrollment, patients are required to have histologically or cytologically confirmed disease, a measurable lesion per RECIST 1.1, and an ECOG performance status of 0 or 1. The study excluded patients who had radiation to the lung within 2 months before screening, or major surgery within 28 days of the first MYTX-011 dose. Patients are also excluded if they have untreated or uncontrolled central nervous system metastases, history of interstitial lung disease or pneumonitis, clinically significant illness that poses a risk, grade 1 neuropathy, history of cirrhosis, haptic fibrosis, esophageal or gastric varices, or other liver disease, or those with active or chronic corneal disorder.
“Today’s announcement of our first subject dosed represents a significant step towards increasing the number of lung cancer patients eligible for treatment using ADCs, including those whose cancers express moderate cMET levels,” said Brian Fiske, PhD, chief scientific officer, and co-founder at Mythic Therapeutics, in the press release.1
1. Mythic Therapeutics announces first subject dosed in phase 1 kismet-01 clinical trial of cmet-targeting antibody-drug conjugate (ADC) MYTX-011 for the treatment of non-small cell lung cancer (NSCLC). News release. Mythic Therapeutics. April 4, 2023. Accessed April 5, 2023. https://bit.ly/4165I6f
2. Clinical study of antibody-drug conjugate MYTX-011 in subjects with non-small cell lung cancer. ClinicalTrials.gov. March 29, 2023. Accessed April 5, 2023. https://clinicaltrials.gov/ct2/show/NCT05652868?term=KisMET-01&draw=2&rank=1