# 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

Source: https://onco.cc/trials/nct07814248/  
OnCo record `nct07814248` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1 trial of TS-104 run by TwoStep Therapeutics, Inc., now recruiting.

## 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 is a phase 1 interventional study registered as NCT07814248 by TwoStep Therapeutics, Inc., with 74 participants planned, started 2026-09-02. Conditions recorded: NSCLC (Non-small Cell Lung Cancer), HNSCC, Endometrial, Ovarian Cancer, Esophageal Cancer, Head & Neck Cancer, Gastric Cancer (GC) and Endometrial Cancer. Interventions recorded: TS-104.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-11-03
- Tags: pipeline; ctgov-ingest
- Registry id: NCT07814248
- Phase: 1
- Setting: 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 Advanced Solid Tumors
- Sponsor: TwoStep Therapeutics, Inc.
- Enrolled: 74

## Sources

- ClinicalTrials.gov NCT07814248: https://clinicaltrials.gov/study/NCT07814248

## Connected records

- cancers: [Endometrial cancer](https://onco.cc/cancers/endometrial/), [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Ovarian cancer](https://onco.cc/cancers/ovarian/)
- drugs: [TS-104](https://onco.cc/drugs/ts-104/)
- companies: [TwoStep Therapeutics](https://onco.cc/companies/twostep-therapeutics/)

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