Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0UHUMZ
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| ADC Name |
Trastuzumab bultecan
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| Synonyms |
IBI354
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| Organization |
Innovent Biologics (Originator)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
Trastuzumab
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
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Antigen Info | ||||
| Payload Name |
NT1
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
PODS-CHX-A"-DTPA
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||||
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| Biliary tract cancer |
1 Trials
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| Breast cancer |
1 Trials
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| Colorectal cancer |
1 Trials
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| Fallopian tube cancer |
1 Trials
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1 Trials
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| Gastric cancer |
1 Trials
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| Gynaecological cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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1 Trials
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| Peritoneal cancer |
1 Trials
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1 Trials
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| Unspecific solid tumor |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
58%
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| Patients Enrolled |
Participants (≥18y) must have HER2-altered advanced solid tumors (Phase 1a) or selected HER2-expressing cancers (Phase 1b/2), adequate organ function, and contraception compliance. Exclusions cover recent antitumor therapies (<4 weeks), uncontrolled infections (HIV/HBV/HCV/COVID-19/tuberculosis/syphilis), cardiovascular risks (QTc>480ms, hypertension), or unresolved toxicities (>Grade 1 per CTCAE v5.0).
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| Administration Dosage |
IBI354 was administered intravenously at 6-15 mg/kg Q3W or Q2W.
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| Related Clinical Trial | |||||
| NCT Number | NCT05636215 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1/2, Multicenter, Open-label Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors | ||||
| Primary Endpoint |
The study assesses safety by tracking serious adverse events (SAEs) and treatment-emergent AEs (TEAEs), defined as any new or worsening clinical incidents occurring up to 30 days post-treatment, along with dose-limiting toxicities (DLTs) within the initial 21-day cycle in Phase Ia.
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| Other Endpoint |
Key efficacy measures include objective response rate (ORR, CR/PR rates), duration of response (DoR, time from response to progression/death), progression-free survival (PFS, time to progression/death), and overall survival (OS, time to death)-all evaluated over a 2-year period.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
90.90%
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| Patients Enrolled |
Participants (≥18y) must have HER2-altered advanced solid tumors (Phase 1a) or selected HER2-expressing cancers (Phase 1b/2), adequate organ function, and contraception compliance. Exclusions cover recent antitumor therapies (<4 weeks), uncontrolled infections (HIV/HBV/HCV/COVID-19/tuberculosis/syphilis), cardiovascular risks (QTc>480ms, hypertension), or unresolved toxicities (>Grade 1 per CTCAE v5.0).
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| Administration Dosage |
IBI354 was administered intravenously at 6-15 mg/kg Q3W or Q2W.
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| Related Clinical Trial | |||||
| NCT Number | NCT05636215 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1/2, Multicenter, Open-label Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors | ||||
| Primary Endpoint |
The study assesses safety by tracking serious adverse events (SAEs) and treatment-emergent AEs (TEAEs), defined as any new or worsening clinical incidents occurring up to 30 days post-treatment, along with dose-limiting toxicities (DLTs) within the initial 21-day cycle in Phase Ia.
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| Other Endpoint |
Key efficacy measures include objective response rate (ORR, CR/PR rates), duration of response (DoR, time from response to progression/death), progression-free survival (PFS, time to progression/death), and overall survival (OS, time to death)-all evaluated over a 2-year period.
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| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligibility requires adult females (≥18y, ECOG 0-1) with advanced ovarian cancer, measurable lesions, and adequate organ function. Exclusions involve specific tumor types, recent therapies (chemotherapy/radiotherapy/surgery), uncontrolled comorbidities, infections, prior transplants, or conditions compromising safety/compliance.
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| Administration Dosage |
intravenous infusion of 12 mg/kg on Day 1 of each 3-week treatment cycle
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| Related Clinical Trial | |||||
| NCT Number | NCT06834672 | Clinical Status | PHASE3 | ||
| Clinical Description | A Multicenter, Randomized, Open-label Phase III Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | ||||
| Primary Endpoint |
The primary objectives compare Progression-free Survival (PFS) and Overall Survival (OS) between IBI354 monotherapy and chemotherapy, assessed per RECIST v1.1, with PFS tracked up to 36 months and OS up to 48 months.
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| Other Endpoint |
Secondary endpoints include safety (adverse events, physical exam changes), efficacy (ORR, DCR, DoR, TTR per RECIST v1.1), quality of life (EORTC QLQ-C30/OV28, EQ-5D-5L), pharmacokinetics (Cmax, AUC, Tmax, CL, V, T1/2), and immunogenicity (ADA/Nab incidence and impact on safety/efficacy/PK).
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References