# TS-104

Source: https://onco.cc/drugs/ts-104/  
OnCo record `ts-104` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

TS-104 is an experimental peptide-drug conjugate from TwoStep Therapeutics, in phase 1 trials for non-small cell lung cancer, head and neck squamous cell carcinoma and endometrial cancer and other cancers.

## Summary

TS-104 is a peptide-drug conjugate from TwoStep Therapeutics. A peptide-drug conjugate that links PIP, an engineered knottin peptide binding five tumour-associated integrins, to the cytotoxic payload MMAE, so the drug is carried into cancer cells that carry these integrins. Its furthest stage is phase 1, for non-small cell lung cancer, head and neck squamous cell carcinoma, endometrial cancer and ovarian cancer. ClinicalTrials.gov registers it in one study linked below. FDA IND clearance announced 9 September 2026; first-in-human phase 1 is RECRUITING on the registry. Whether it works in people has not been established unless a trial below reports it.

## Fields

- Kind: Treatment
- Status: phase-1
- Last checked: 2026-11-03
- Tags: pipeline; ctgov-ingest
- Code: TS-104
- Modality: Peptide-drug conjugate
- Mechanism: A peptide-drug conjugate that links PIP, an engineered knottin peptide binding five tumour-associated integrins, to the cytotoxic payload MMAE, so the drug is carried into cancer cells that carry these integrins.

## Sources

- TwoStep Therapeutics: twosteptx.com: https://twosteptx.com/twostep-therapeutics-announces-oversubscribed-62-5-million-series-a-financing-and-fda-clearance-of-ind-for-first-in-class-peptide-drug-conjugate/
- TwoStep Therapeutics: twosteptx.com: https://twosteptx.com/twostep-therapeutics-announces-oversubscribed-62-5-million-series-a-financing-and-fda-clearance-of-ind-for-first-in-class-peptide-drug-conjugate/
- TwoStep Therapeutics: twosteptx.com: https://twosteptx.com/science/
- TwoStep Therapeutics: clinicaltrials.gov: https://clinicaltrials.gov/api/v2/studies/NCT07814248
- ClinicalTrials.gov: trials of TS-104: https://clinicaltrials.gov/search?intr=TS-104

## Connected records

- cancers: [Endometrial cancer](https://onco.cc/cancers/endometrial/), [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/)
- companies: [TwoStep Therapeutics](https://onco.cc/companies/twostep-therapeutics/)
- trials: [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](https://onco.cc/trials/nct07814248/)

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JSON: https://onco.cc/api/v1/entities/ts-104.json