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Life sciences · Phase 1 Trial

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

ClinicalTrials.gov · September 30, 2026

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AI Summary

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What was studied

Phase 1 Trial.

Key findings

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Safety

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Who this may help

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Evidence assessment

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Study design

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Directness

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Consistency

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Risk of bias

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Sample adequacy

not graded

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Source abstract

Registry record from ClinicalTrials.gov (NCT07814248). This is a study registration, not published results. Lead sponsor: TwoStep Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 74 participants (ESTIMATED). Conditions: NSCLC (Non-small Cell Lung Cancer), HNSCC, Endometrial, Ovarian Cancer, Esophageal Cancer, Head & Neck Cancer, Gastric Cancer (GC), Endometrial Cancer. Interventions: DRUG: TS-104. Primary outcome measures: Number of Participants with Adverse Events Following Administration of TS-104 , From the first dose of TS-104 until 28 days after the last dose of TS-104 (up to 26 months); Number of Participants with Dose Limiting Toxicities (DLTs) from TS-104 , Up to 21 days (for 2Q3W regimen) or Up to 28 days (for Q2W regimen) from the first dose. Brief summary: 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

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