Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0KDTFA
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| ADC Name |
F0002-ADC
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| Synonyms |
F0002-ADC; CD30-DM1; B006; F0002
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| Organization |
Shanghai Pharmaceuticals (SPH) (Originator);Fudan-Zhangjiang Bio-Pharmaceutical
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
3.37
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| Structure |
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| Antibody Name |
Brentuximab
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Antibody Info | ||||
| Antigen Name |
Tumor necrosis factor receptor superfamily member 8 (TNFRSF8)
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Antigen Info | ||||
| Payload Name |
DM1
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Succinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate (SMCC)
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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| Combination Type |
emtansine
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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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| Hodgkin lymphoma |
1 Trials
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| Mature t-cell lymphoma |
1 Trials
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| Mycosis fungoides |
1 Trials
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| Unspecific hematological malignancies |
1 Trials
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| Unspecific non-hodgkin lymphoma |
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 |
Eligibility criteria require: ECOG 0-1; centrally confirmed relapsed/refractory CD30+ malignancies (prioritizing cHL, ALCL, MF); ≥1 measurable lesion (nodal ≥15mm/extranodal ≥10mm, skin nodules for MF); adequate hematologic/organ function (Hb≥80g/L, NEUT≥1.5×10<sup>9</sup>/L, etc.); washout periods (≥8 weeks post-transplant, ≥4 weeks post-therapy [6 weeks for alkylators]); life expectancy >3 months; and voluntary informed consent.
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| Administration Dosage |
Every 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg
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| Related Clinical Trial | |||||
| NCT Number | NCT03894150 | Clinical Status | PHASE1 | ||
| Clinical Description | A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies. | ||||
| Primary Endpoint |
The primary endpoint is MTD (maximum tolerable dose) assessed within 21 days following a single dose administration.
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| Other Endpoint |
Secondary endpoints include ORR (objective response rate), DOR (duration of response), and PFS (progression-free survival) evaluated every 2 cycles (21-day cycles) until tumor progression/death/3 years; pharmacokinetic parameters (Cmax, AUC, Tmax, T1/2, CL, Vd) and immunogenicity (Anti-F0002-ADC antibodies) measured 1 month post-final dose; with safety monitoring for adverse events and laboratory abnormalities until 1 month post-treatment.
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References