{"entity":{"id":"si-b001","kind":"drug","name":"SI-B001","aka":[],"tldr":"SI-B001 is an experimental investigational agent whose form is not stated in the registry from Sichuan Baili Pharmaceutical in phase 3 trials for non-small-cell lung cancer and head and neck squamous cell carcinoma, with its target not yet stated publicly.","summary":"SI-B001 is an investigational agent whose form is not stated in the registry developed by Sichuan Baili Pharmaceutical. Its molecular target is not stated in the ClinicalTrials.gov intervention record, and OnCo has not confirmed one from the sponsor's pipeline page. ClinicalTrials.gov describes the intervention as: SI-B001 is administered by intravenous drip once weekly (QW). 120 min ± 10 min after the first intravenous drip, if the infusion reaction is tolerable during the first dose, the subsequent infusion can be completed within 60-120 min (unless. It is the investigational product in 7 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including the phase 3 study NCT05020769 (SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer), in non-small-cell lung cancer and head and neck squamous cell carcinoma. The largest, NCT05949606, plans to enrol 95 participants (actual) with primary completion expected 2026-12. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of SI-B001","url":"https://clinicaltrials.gov/search?intr=SI-B001"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05020769","nct06668961","nct05949606","nct05020457","nct05044897","nct05054439","nct05668858"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"bispecific antibody (SI-B001 is izalontamab, EGFR x HER3; INN stem -mab; form not stated in the registry record)","mechanism":"Mechanism not stated in the ClinicalTrials.gov record or on the sponsor's pipeline page.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/si-b001/","neighbours":{"cancer":[{"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/"}],"company":[{"id":"systimmune","kind":"company","name":"SystImmune / Sichuan Biokin","route":"/companies/systimmune/"}],"trial":[{"id":"nct05943795","kind":"trial","name":"A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma","route":"/trials/nct05943795/"},{"id":"nct05054439","kind":"trial","name":"A Clinical Study of SI-B001 in Combination With Paclitaxel/Docetaxel in the Treatment of Recurrent and Metastatic HNSCC","route":"/trials/nct05054439/"},{"id":"nct05044897","kind":"trial","name":"A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC","route":"/trials/nct05044897/"},{"id":"nct06668961","kind":"trial","name":"A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Sq","route":"/trials/nct06668961/"},{"id":"nct05668858","kind":"trial","name":"A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma","route":"/trials/nct05668858/"},{"id":"nct05949606","kind":"trial","name":"A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer","route":"/trials/nct05949606/"},{"id":"nct05020457","kind":"trial","name":"SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC.","route":"/trials/nct05020457/"},{"id":"nct05020769","kind":"trial","name":"SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer","route":"/trials/nct05020769/"}]}}