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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

Name: 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 — clinical trial record (NCT07814248)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 1

SponsorTwoStep Therapeutics, Inc.

Started2026-10

View on ClinicalTrials.gov ↗

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

Trial Details

NCT Number	NCT07814248
Lead Sponsor	TwoStep Therapeutics, Inc.
Conditions	NSCLC (Non-small Cell Lung Cancer), HNSCC, Endometrial, Ovarian Cancer, Esophageal Cancer, Head & Neck Cancer, Gastric Cancer (GC), Endometrial Cancer
Enrollment	74 participants
Start Date	2026-10
Primary Completion	2028-08 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-09-10