{"entity":{"id":"ts-104","kind":"drug","name":"TS-104","aka":[],"tldr":"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.","status":"phase-1","asOf":"2026-11-03","links":[{"label":"TwoStep Therapeutics: twosteptx.com","url":"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/"},{"label":"TwoStep Therapeutics: twosteptx.com","url":"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/"},{"label":"TwoStep Therapeutics: twosteptx.com","url":"https://twosteptx.com/science/"},{"label":"TwoStep Therapeutics: clinicaltrials.gov","url":"https://clinicaltrials.gov/api/v2/studies/NCT07814248"},{"label":"ClinicalTrials.gov: trials of TS-104","url":"https://clinicaltrials.gov/search?intr=TS-104"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","head-and-neck","endometrial","ovarian","esophageal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["twostep-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07814248"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"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.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ts-104/","neighbours":{"cancer":[{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"}],"company":[{"id":"twostep-therapeutics","kind":"company","name":"TwoStep Therapeutics","route":"/companies/twostep-therapeutics/"}],"trial":[{"id":"nct07814248","kind":"trial","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","route":"/trials/nct07814248/"}]}}