Drugs / IBI354
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05636215 | Apr 2023 → Apr 2025 overdue | cancer of unknown primary site | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05582499 | Nov 2022 → Dec 2027 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07377643 | Feb 2026 → Apr 2028 expected | HER2 positive breast carcinoma | Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Recruiting | No outcome recorded |
| Phase 3 | NCT06834672 | Mar 2025 → Dec 2027 expected | fallopian tube cancer, ovarian carcinoma, primary peritoneal carcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-06-03 | Innovent Biologics (Suzhou) Co. Ltd. | Results 2025 ASCO Presentation: Innovent Biologics Announces Updated Data of IBI354 (Novel anti-HER2 ADC) From the Phase 1/2 Clinical Study in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors innoventbio.com ↗
IBI354 has demonstrated promising anti-tumor efficacy and favorable safety profiles across multiple solid tumors. |
| 2024-09-18 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Delivers Oral Presentations on Clinical Data of IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate) in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors at the 2024 ESMO Congress innoventbio.com ↗
IBI354 monotherapy showed promising efficacy signals in multiple tumor types. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-13 | Innovent Biologics (Suzhou) Co. Ltd. | Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for First Line Treatment of HER2-positive Breast Cancer innoventbio.com ↗ |
| 2025-06-03 | Innovent Biologics (Suzhou) Co. Ltd. | 2025 ASCO Presentation: Innovent Biologics Announces Updated Data of IBI354 (Novel anti-HER2 ADC) From the Phase 1/2 Clinical Study in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors innoventbio.com ↗ |
| 2025-03-24 | Innovent Biologics (Suzhou) Co. Ltd. | Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for Platinum-resistant Ovarian Cancer innoventbio.com ↗ |
| 2024-09-18 | Innovent Biologics (Suzhou) Co. Ltd. | Innovent Delivers Oral Presentations on Clinical Data of IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate) in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors at the 2024 ESMO Congress innoventbio.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IBI354 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06834672 ↗ |
| Modality | Monoclonal antibody | “an anti-HER2 ADC” NCT05582499 ↗ |
| Route | Intravenous | “intravenous infusion of 12 mg/kg on Day 1 of each 3-week treatment cycle” NCT06834672 ↗ |