{"entity":{"id":"nct07358585","kind":"trial","name":"A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of serplulimab in colorectal cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer is a phase 1/2, randomised interventional study registered as NCT07358585 by Shanghai Henlius Biotech, with a registry enrolment figure of 126 participants, started 2026-01-31 and due to reach its primary completion in 2027-07-28. Interventions recorded: HLX43 dose 1 + HLX07; HLX43 dose 2 + HLX07; HLX43 dose 3 + Serplulimab; HLX43 dose 4 + Serplulimab. Conditions listed: Colon Cancer Adenocarcinoma. Primary outcome: ORR; PFS. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma; and locally tested and confirmed as a RAS/BRAF wild-type tumor (only for Part 1 );\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07358585","url":"https://clinicaltrials.gov/study/NCT07358585"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07358585","phase":"1/2","setting":"A Phase Ib/II Study to Evaluate the Efficacy, Safety and Tolerance of HLX43 (an Anti-PD-L1 Antibody Conjugated) Combined With HLX07 (a Recombinant Anti-EGFR Humanized Monoclonal Antibody) or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer","sponsor":"Shanghai Henlius Biotech","enrolled":126,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07358585/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"serplulimab","kind":"drug","name":"Serplulimab","route":"/drugs/serplulimab/"}],"company":[{"id":"henlius","kind":"company","name":"Shanghai Henlius Biotech","route":"/companies/henlius/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}