Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0RIFMO
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| ADC Name |
LCB84
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| Synonyms |
LCB84
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| Organization |
LCB (Originator);Janssen Biotech (Top20 MNC);Mediterranea Theranostic
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| Drug Status |
Phase 1/2
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| Drug-to-Antibody Ratio |
4
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| Antibody Name |
Hu2G10
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Antibody Info | ||||
| Antigen Name |
Tumor-associated calcium signal transducer 2 (TACSTD2)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
β-glucuronide linker
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Linker Info | ||||
| Conjugate Type |
Enzymatic Catalysis
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2027 Update
The indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||
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| Unspecific solid tumor |
1 Trials
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2027 Update
ADC-specific functional property
Bystander Killing Effect
| Bystander Killing Effect | Description | Reference |
|---|---|---|
| yes |
MMAE is also cell-permeable in its free drug form and can lead to increased efficacy of LCB84 via a bystander effect, enabling activity in heterogenous tumors.
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[1]
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
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 | [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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| Administration Dosage |
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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 | ||||
| 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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References