Payload Information
General Information of This Payload
| Payload ID | PAY0IIIEN |
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| Name | NT1 |
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| Target | DNA topoisomerase 1 (TOP1) | |||||
| Structure |
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Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
Trastuzumab bultecan [Phase 3]
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 | Phase 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
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| 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 | Phase 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
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| 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 | Phase 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
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| 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