MTC antitumor
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An upcoming study will test a novel drug’s efficacy, safety, and tolerability for treating medullary thyroid carcinoma (MTC).

Researchers will soon initiate the phase 1 and 2 open-label studies of the therapeutic profile of TY-1091 in a study performed for the first time in humans that plans to include a total of 248 patients previously diagnosed with MTC.

The trial consists of 2 phases. The first phase will evaluate the dose-limiting toxicity during the first 25 days of dosing, as well as the number of participants that developed adverse events and serious adverse events during a time frame of up to 24 weeks.


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Phase 2, considered the expansion part, will measure the overall response rate as the primary outcome during a follow-up time of 24 weeks. During both phases, the participants will receive multiple doses of TY-1091, either 10 mg or 100 mg, once daily through oral administration, with a dose level of 20 mg to 800 mg.

The secondary outcomes during phase 1 include overall response rate, immune overall response rate, and disease control rate during 24 weeks; clinical benefit rate and duration of response for 1 year; progression-free survival, and overall survival for 33 months; and finally, the area under the curve (AUC) from time 0 and from time 0 to infinity, the truncated AUC to 24 hours, inflearance rate constant, apparent clearance, mean residence time, and the apparent volume of distribution in the first 46 days of dosing.

Moreover, during both phases 1 and 2, the researchers will assess the pharmacokinetic parameters, including maximum plasma drug concentration and terminal elimination half-life on the first 46 days.

Patients of 18 years or older, of both sexes, with a pathologically diagnosed nonresectable advanced solid tumor, including an MTC or a RET-altered solid tumor, with a life expectancy of 3 months or more, adequate organ function, and ability to swallow capsules, can become part of the sample.

This study, named “A phase I/II study of oral TY-1091 in adult patients with advanced solid tumors, including RET-fusion non small cell lung cancer, RET mutation medullary thyroid cancer, and other tumors with RET alterations,” will possibly start in March 2023, and is expected to be completed in December 2025.

Reference

A study of TY-1091 in patients with advanced solid tumors. ClinicalsTrials.gov. Accessed January 9, 2023.