Linker Information
General Information of This Linker
| Linker ID |
LIN0XNWWH
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| Linker Name |
β-glucuronide linker
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| Antibody-Linker Relation |
Cleavable
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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
caxmotabart entudotin [Phase 3]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
66.70
42.90 % |
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| Patients Enrolled |
Patients with HER2-expresssing advanced solid tumors who had failed prior standard of care therapies.
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| Administration Dosage |
FS-1502 was given IV once in 21-day or 28-day cycle at doses of 0.10-3.50 mg/kg.
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LCB84 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients (ECOG 0-1) must have advanced solid tumors refractory to standard therapy (Phase 1: all types; Phase 2: selected indications). Prior TROP2-directed therapy is allowed. Key requirements: measurable disease (RECIST 1.1/RANO-BM), archival/pretreatment biopsy, and adequate organ function (ANC ≥1.5×10<sup>9</sup>/L, platelets ≥100×10<sup>9</sup>/L, Hb ≥9 g/dL, AST/ALT ≤2.5×ULN). Exclusions: active/progressing CNS metastases (unless stable for ≥1 month post-treatment without steroids >4 mg dexamethasone), unresolved Grade >1 toxicities (except alopecia/vitiligo), recent systemic therapy (within 4 weeks/5 half-lives), or high-dose steroids (>10 mg prednisone/day).
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| Related Clinical Trial | |||||
| NCT Number | NCT05941507 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors
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| Primary Endpoint |
The study assesses the safety of LCB84 monotherapy and combination therapy with anti-PD-1 antibodies over 48 months by monitoring AEs/SAEs. The recommended Phase 2 dose is determined within 24 months based on tolerability, PK data, and preliminary anti-tumor activity. Efficacy endpoints-ORR, clinical benefit rate (CBR), DOR, TTP, PFS, and OS-are evaluated over 24 months via RECIST 1.1, iRECIST, and RANO-BM criteria.
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| Other Endpoint |
PK analysis measures LCB84 plasma concentrations over 48 months, while immunogenicity is assessed via ADA detection. Phase 1 also evaluates anti-tumor activity (ORR, DOR, TTP, PFS) per RECIST 1.1, iRECIST, and RANO-BM within 24 months.
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LNCB74 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Inclusion: Adults (≥18) with advanced/metastatic solid tumors (RECIST 1.1-measurable), ECOG 0-1, life expectancy ≥12 weeks, adequate organ function, willingness for biopsies, and contraception compliance. Exclusion: Prior MMAE-ADC therapy, platinum-refractory disease, active CNS metastases, Grade≥2 neuropathy/corneal disease, uncontrolled infections (HIV/HBV/HCV), recent anticancer therapies (chemotherapy within 2 weeks, antibodies within 4 weeks, radiotherapy within 2-4 weeks), immunosuppression, or significant comorbidities (cardiovascular, interstitial lung disease, bowel obstruction). Pregnancy, breastfeeding, or unresolved toxicities (>Grade 1) also exclude participation.
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| Administration Dosage |
LNCB74 is an antibody drug conjugate being evaluated as a potential treatment for participants with advanced solid tumors. Participants will receive LNCB74 into the vein (IV; intravenously) in 21-day dosing cycles. Participants will continue treatment in the absence of unacceptable toxicities and unequivocal disease progression.
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| Related Clinical Trial | |||||
| NCT Number | NCT06774963 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With Advanced Solid Tumors
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| Primary Endpoint |
The study aims to evaluate the safety and tolerability of LNCB74 over 24 months, assessing incidence of AEs, SAEs, DLTs, discontinuations, and deaths per NCI CTCAE v5.0. Additionally, it seeks to determine the RP2D (based on MTD, MAD, and cumulative safety/PK data) and define the maximum tolerated/feasible dose.
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| Other Endpoint |
Efficacy measures include ORR, DOR, DCR, and PFS at 6/24 months (per RECIST 1.1), alongside correlations between B7-H4 expression (via central IHC) and clinical outcomes (ORR, DOR, DCR, PFS). Pharmacokinetics (Tmax, AUC, T1/2, Cmax) are evaluated across multiple cycles (Days 1-15, Cycles 1-9). Immunogenicity (anti-drug antibodies) is monitored for 24 months.
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References
