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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

NCT07814248

This study is recruiting at 3 US sites in 3 states, according to its ClinicalTrials.gov record last updated .

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

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • NSCLC (Non-small Cell Lung Cancer)
  • HNSCC
  • Endometrial
  • Ovarian Cancer
  • Esophageal Cancer
  • Head & Neck Cancer
  • Gastric Cancer (GC)
  • Endometrial Cancer

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
TwoStep Therapeutics, Inc.
Last updated on ClinicalTrials.gov
September 30, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Ohio · 1

  • Site 06 · Maumee, OH

Oregon · 1

  • Site 02 · Portland, OR

Virginia · 1

  • Site 04 · Fairfax, VA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.