{"entity":{"id":"tac-001","kind":"drug","name":"TAC-001","aka":["CD22 TRAAC"],"tldr":"TAC-001 is an experimental toll-like receptor agonist antibody conjugate from Tallac Therapeutics, in phase 1 trials for advanced or metastatic solid tumours and cholangiocarcinoma.","summary":"TAC-001 (CD22 TRAAC) is a toll-like receptor agonist antibody conjugate (TRAAC) from Tallac Therapeutics. A TLR9 agonist (T-CpG) conjugated to an antibody against CD22, which is found only on B cells, including tumour-infiltrating B cells; it delivers the immune stimulant to B cells to set off innate and adaptive anti-tumour immune responses. Its furthest stage is phase 1, for advanced or metastatic solid tumours and cholangiocarcinoma (biliary tract cancer). ClinicalTrials.gov registers it in one study linked below. Phase 1/2 INCLINE-101 (NCT05399654; registry status UNKNOWN, i.e. not updated). FDA Fast Track for previously treated locally advanced unresectable or metastatic cholangiocarcinoma, 20 October 2025. Whether it works in people has not been established unless a trial below reports it.","status":"phase-1","asOf":"2026-11-03","links":[{"label":"Tallac Therapeutics: tallactherapeutics.com","url":"https://www.tallactherapeutics.com/news/tallac-presents-first-clinical-data-for-tac-001-at-sitc-2023/"},{"label":"Tallac Therapeutics: tallactherapeutics.com","url":"https://www.tallactherapeutics.com/news/fda-grants-fast-track-designation-to-tac-001/"},{"label":"Tallac Therapeutics: clinicaltrials.gov","url":"https://clinicaltrials.gov/study/NCT05399654"},{"label":"ClinicalTrials.gov: trials of TAC-001","url":"https://clinicaltrials.gov/search?intr=TAC-001"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["cd22"],"drugs":[],"companies":["tallac-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05399654"],"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":"TAC-001","modality":"Toll-like receptor agonist antibody conjugate (TRAAC)","mechanism":"A TLR9 agonist (T-CpG) conjugated to an antibody against CD22, which is found only on B cells, including tumour-infiltrating B cells; it delivers the immune stimulant to B cells to set off innate and adaptive anti-tumour immune responses.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/tac-001/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"target":[{"id":"cd22","kind":"target","name":"CD22","route":"/targets/cd22/"}],"company":[{"id":"tallac-therapeutics","kind":"company","name":"Tallac Therapeutics","route":"/companies/tallac-therapeutics/"}],"trial":[{"id":"nct05399654","kind":"trial","name":"A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors","route":"/trials/nct05399654/"}]}}