TwoStep Therapeutics, Inc.
A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects with Select Advanced Solid Tumors. The main goals of this study are to: * Find the recommended dose of TS-104 that can safely be given to participants * Learn more about the side effects of TS-104 * Learn more about the effectiveness of TS-104 * Learn more about the pharmacokinetics of TS-104
This study is testing an investigational drug called TS-104 in participants with select advanced solid tumors that have not responded to other treatments. The main purpose is to find out whether TS-104 is safe and how well it is tolerated. It will also study whether TS-104 works to treat solid tumors. TS-104 is a peptide-drug conjugate that delivers the anticancer drug monomethyl auristatin E (MMAE) to tumors using a targeting peptide that binds to certain integrins commonly found on solid tumors The study has two parts: 1. Dose Escalation: when doses of TS-104 are gradually increased are t…
Inclusion Criteria: * Males \& females ≥18 years of age at the time of consent * Willingness to provide written informed consent, according to local guidelines. * Subjects who have histologically or cytologically documented, unresectable locally advanced, or metastatic solid malignancy that is progressing or has failed the minimum therapies listed below or who are intolerant of, ineligible for, or refuse standard of care (SOC) therapy according to local guidelines: 1. Non-small cell lung cancer (NSCLC) 2. Head and neck squamous cell carcinoma (HNSCC) 3. Esophageal cancer 4. Endometri…
TS-104 is a peptide-drug conjugate that delivers the anticancer drug MMAE to tumors using a targeting peptide that binds to certain integrins commonly found on solid tumors.