General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0ZAFBL
ADC Name
IBI-129
Synonyms
IBI-129; IBI 129; IBI129
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Organization
Innovent Biologics, Inc.
Drug Status
Phase 1/2
Antibody Name
Undisclosed
Antigen Name
CD276 antigen (CD276)
 Antigen Info 
Payload Name
Undisclosed
Therapeutic Target
Stimulator of interferon genes protein (STING1)
 Target Info 
Linker Name
Undisclosed
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
Unspecific solid tumor
1 Trials
Trial ID
NCT05991349
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT05991349
PHASE1|||PHASE2
A Phase 1/2 Study of IBI129 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
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.
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.
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.
References
Ref 1 A Study of IBI129 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors