Linker Information
General Information of This Linker
| Linker ID |
LIN0NJVJL
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| Linker Name |
Mal-PEG24-Val-Ala-PABC
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| Linker Type |
Cathepsin-cleavable linker
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| Antibody-Linker Relation |
Cleavable
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| Structure |
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Each Antibody-drug Conjugate Related to This Linker
Full Information of The Activity Data of The ADC(s) Related to This Linker
OBI-992 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible subjects must be ≥18yo with metastatic/advanced solid tumors (measurable per RECIST v1.1, ECOG 0-1) refractory to standard therapy, with adequate organ function (ALT/AST ≤3×ULN [≤5×ULN with liver mets], bilirubin ≤1.5×ULN, CrCl >50mL/min, ANC ≥1500/uL). Special populations: HIV+ (CD4≥350 cells/uL, VL<200 copies/mL), HBV (suppressed VL), HCV (curative treatment with undetectable VL). Part B requires NSCLC/SCLC histology. All subjects must provide pretreatment tumor biopsy (archival acceptable) and comply with contraception requirements (120 days post-treatment).
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| Administration Dosage |
OBI-992 at dose level 1, 2, 3, 4, 6, 8, 10 mg/kg, Q3W
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| Related Clinical Trial | |||||
| NCT Number | NCT06480240 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-992 in Subjects With Advanced Solid Tumors
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| Primary Endpoint |
Primary objectives include assessing OBI-992 safety/tolerability (AEs/SAEs/lab abnormalities per NCI CTCAE v5.0), determining MTD/RP2D, and evaluating preliminary efficacy (ORR, CBR, DOR, DCR, PFS per RECIST v1.1) over a study duration of up to 2 years and 2 months.
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| Other Endpoint |
Secondary objectives involve characterizing OBI-992 immunogenicity (ADA incidence) and serum PK parameters (Cmax, AUC, T1/2, CL, Vdss) for both OBI-992 and active metabolite exatecan throughout the study period.
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