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IBI-354
i
Other names: IBI-354, IBI354
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Company:
Innovent Biologics
Drug class:
Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
Related drugs:
13d
FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
P2, N=716, Recruiting, Fudan University | Trial completion date: Sep 2028 --> Sep 2029 | Trial primary completion date: Dec 2026 --> Dec 2027
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
|
Herceptin (trastuzumab) • carboplatin • Focus V (anlotinib) • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • Andewei (benmelstobart) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Idafang (ivonescimab) • bulumtatug fuvedotin (9MW2821) • AiRuiLi (adebrelimab) • IBI-354 • SHR-4602 • TQB2102 • TQB2868 • anbenitamab repodatecan (JSKN003) • tizetatug rezetecan (SHR-A1921)
3ms
IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (clinicaltrials.gov)
P3, N=540, Recruiting, Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Not yet recruiting --> Recruiting
Enrollment open
|
ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HR positive
|
Herceptin (trastuzumab) • paclitaxel • docetaxel • Perjeta (pertuzumab) • IBI-354
4ms
IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (clinicaltrials.gov)
P3, N=540, Not yet recruiting, Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
New P3 trial
|
ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HR positive
|
Herceptin (trastuzumab) • paclitaxel • docetaxel • Perjeta (pertuzumab) • IBI-354
10ms
A Phase II, Single-Center Study Evaluating IBI354 as Neoadjuvant Therapy for HER2-Positive Advanced Epithelial Ovarian Cancer (ChiCTR2500104920)
P2, N=31, Not yet recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 expression
|
IBI-354
1year
HeriCare-Ovarian01: Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
P3, N=450, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Platinum resistant
|
paclitaxel • IBI-354
over1year
Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
P3, N=450, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
New P3 trial
|
paclitaxel • IBI-354
over1year
CIBI354A101: A First-in-human Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=368, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Jul 2025 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Apr 2025
Enrollment open • Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 expression
|
IBI-354
over3years
A First-in-human Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=444, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
New P1/2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 expression
|
IBI-354
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