Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0WWBVZ
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| ADC Name |
BC3195
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| Synonyms |
BC3195
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| Organization |
WuXi AppTec (Originator);BioCity Biopharmaceutics (Originator)
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| Drug Status |
Phase 1/2
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| Antibody Name |
Anti-CDH3 antibody
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Antibody Info | ||||
| Antigen Name |
Cadherin-3 (CDH3)
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Antigen Info | ||||
| Payload Name |
MMAE
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Val-Cit dipeptide linker
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Linker Info | ||||
| Conjugate Type |
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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| Breast cancer |
1 Trials
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| Colorectal cancer |
1 Trials
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| Head and neck cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Oesophageal cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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| Unspecific solid tumor |
2 Trials
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| Urothelial cancer |
1 Trials
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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 | [1] | ||||
| Patients Enrolled |
Eligible adults (≥18 y, ECOG 0-1) must have CDH3-expressing metastatic solid tumors, measurable lesions (RECIST 1.1), ≥3-month life expectancy, and adequate organ function. Exclusions include prior allogeneic transplants, uncontrolled hypertension, active CNS metastases, ocular/cardiac/pulmonary comorbidities, recent immunosuppression or CYP3A4 modulators, or pregnancy. Contraception is mandatory for 6 months post-treatment.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06548672 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase Ia/Ib, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients With Locally Advanced or Metastatic Solid Tumors | ||||
| Primary Endpoint |
The study evaluates Dose Limiting Toxicities (DLTs) within the first 21 days of treatment to determine the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D). Incidence and severity of all Adverse Events (AEs) are monitored from screening through 12 weeks post-treatment.
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| Other Endpoint |
Efficacy is assessed via ORR, DCR, DoR, TTP, PFS (per RECIST 1.1), and OS (up to 100 months). Pharmacokinetics (AUC, Cmax, Tmax, t1/2, Vd, CL) are analyzed for BC3195 through 21 days post-last dose, alongside immunogenicity (ADA) monitoring for 30 days.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants (≥18 years, ECOG 0-1) must provide informed consent and have metastatic solid tumors refractory to standard therapies with ≥3-month life expectancy. Key exclusions include pregnancy, recent anticancer treatment, uncontrolled hypertension, active infections, cardiovascular disease, or poor compliance potential as judged by investigators. Effective contraception is required for 6 months post-treatment.
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| Administration Dosage |
BC3195 is administered as 1 hour (h) IV infusion every 3 weeks. An evaluation of seven dose levels (DLs) is planned: 0.3, 0.6, 1.2, 1.8, 2.4, 3.0 and 3.6 mg/kg with a BOIN design guiding dose escalation.
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| Related Clinical Trial | |||||
| NCT Number | NCT05957471 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase Ia/Ib, Open-Label, First-in-human, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BC3195 in Patients With Locally Advanced or Metastatic Solid Tumors | ||||
| Primary Endpoint |
The trial will assess dose limiting toxicities (DLTs) observed during the first treatment cycle (21 days) to evaluate safety parameters.
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References