# HLX22

Source: https://onco.cc/drugs/hlx22/  
OnCo record `hlx22` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

HLX22 is an experimental monoclonal antibody from Shanghai Henlius Biotech in phase 3 trials for gastric & gastro-oesophageal junction cancer and HR-positive / HER2-negative breast cancer, aimed at HER2.

## Summary

HLX22 is a monoclonal antibody developed by Shanghai Henlius Biotech. Its target is HER2 (the sponsor names HER2). The sponsor states: HLX22 is a recombinant humanised anti-HER2 monoclonal antibody injection, given at 15 mg/kg every three weeks in combination with trastuzumab and chemotherapy (XELOX) in HER2-positive gastric or gastroesophageal junction adenocarcinoma. It is the investigational product in 2 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including the phase 3 study NCT06532006 (A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer), in gastric & gastro-oesophageal junction cancer and HR-positive / HER2-negative breast cancer. The largest, NCT06532006, plans to enrol 550 participants with primary completion expected 2027-06-01. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- Modality: monoclonal antibody
- Mechanism: HLX22 is a recombinant humanised anti-HER2 monoclonal antibody injection, given at 15 mg/kg every three weeks in combination with trastuzumab and chemotherapy (XELOX) in HER2-positive gastric or gastroesophageal junction adenocarcinoma.

## Sources

- ClinicalTrials.gov: trials of HLX22: https://clinicaltrials.gov/search?intr=HLX22

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)
- trials: [A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients](https://onco.cc/trials/nct06832202/), [A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer](https://onco.cc/trials/nct06532006/)

---
JSON: https://onco.cc/api/v1/entities/hlx22.json