Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0ZAFBL
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| ADC Name |
IBI-129
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| Synonyms |
IBI-129; IBI 129; IBI129
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| Organization |
Innovent Biologics, Inc.
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| Drug Status |
Phase 1/2
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| Antibody Name |
Undisclosed
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| Antigen Name |
CD276 antigen (CD276)
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Antigen Info | ||||
| Payload Name |
Undisclosed
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| Therapeutic Target |
Stimulator of interferon genes protein (STING1)
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Target Info | ||||
| Linker Name |
Undisclosed
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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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| Unspecific solid tumor |
1 Trials
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General Information of The Activity Data Related to This ADC
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] | ||||
| Patients Enrolled |
Eligible subjects must be ≥18 years with measurable disease (RECIST 1.1), ECOG 0-1, and adequate organ function. Key exclusions include recent antitumor therapy (within 4 weeks/5 half-lives), prior topoisomerase I inhibitor ADC failure, planned antitumor therapy during study, or symptomatic CNS metastases.
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| Administration Dosage |
Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.
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| Related Clinical Trial | |||||
| NCT Number | NCT05991349 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1/2 Study of IBI129 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors | ||||
| Primary Endpoint |
The study evaluates safety through adverse events (NCI CTCAE v5.0), physical exams, vital signs, and determines MTD/RP2D of IBI129 over 12-24 months.
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| Other Endpoint |
Pharmacokinetic parameters (Cmax, AUC, Tmax, CL, V, T1/2) and immunogenicity of IBI129 are assessed over 12 months, while efficacy endpoints (ORR, DoR, DCR, TTR, PFS, OS) follow RECIST v1.1 criteria over 24 months.
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References
