# A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer

Source: https://onco.cc/trials/nct07358585/  
OnCo record `nct07358585` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT07358585: https://clinicaltrials.gov/study/NCT07358585

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Serplulimab](https://onco.cc/drugs/serplulimab/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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