# IBI354

Source: https://onco.cc/drugs/ibi354/  
OnCo record `ibi354` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

IBI354 is an experimental antibody-drug conjugate from Innovent Biologics (Suzhou) in phase 3 trials for HER2-positive breast cancer and ovarian cancer, aimed at HER2.

## Summary

IBI354 is an antibody-drug conjugate developed by Innovent Biologics (Suzhou) and Innovent Biopharmaceutical Technology (Hangzhou). Its target is HER2 (the sponsor names HER2). The sponsor states: IBI354 is a HER2-targeting antibody-drug conjugate (ADC), given as a 12 mg/kg IV infusion every three weeks, studied versus investigator's choice of chemotherapy in HER2-expressing tumours. ClinicalTrials.gov describes the intervention as: Recombinant Anti-HER2 monoclonal Antibody-Camptothecin derivative conjugate for injection. It is the investigational product in 3 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT07377643 (IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer) and NCT06834672 (Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer), in HER2-positive breast cancer and ovarian cancer. The largest, NCT07377643, plans to enrol 540 participants with primary completion expected 2028-04-28. 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: ADC
- Mechanism: IBI354 is a HER2-targeting antibody-drug conjugate (ADC), given as a 12 mg/kg IV infusion every three weeks, studied versus investigator's choice of chemotherapy in HER2-expressing tumours.

## Sources

- ClinicalTrials.gov: trials of IBI354: https://clinicaltrials.gov/search?intr=IBI354

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [Ovarian cancer](https://onco.cc/cancers/ovarian/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [Innovent Biologics](https://onco.cc/companies/innovent/)
- trials: [A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors](https://onco.cc/trials/nct05636215/), [IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer](https://onco.cc/trials/nct07377643/), [Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer](https://onco.cc/trials/nct06834672/)

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JSON: https://onco.cc/api/v1/entities/ibi354.json