Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0ARHOG
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| ADC Name |
BIIB015
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| Synonyms |
BIIB015; BIIB-015
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| Organization |
Biogen (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
3 to 4
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| Structure |
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| Antibody Name |
HuB3F6
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Antibody Info | ||||
| Antigen Name |
Teratocarcinoma-derived growth factor 1 (TDGF1)
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Antigen Info | ||||
| Payload Name |
DM4
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
N-succinimidyl 4-(2-pyridyldithio) butanoate (SPDB)
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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| Combination Type |
ravtansine
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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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| Unspecific solid tumor |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Discovered Using Cell Line-derived Xenograft Model
| Standard Type | Value | Units | Cell Line | Disease Model |
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| Tumor Growth Inhibition value (TGI) |
≈ 53.4
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%
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MDA-MB-231 cells
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Breast adenocarcinoma
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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 patients must be ≥18 years, have relapsed/refractory solid tumors with no standard options, and ECOG ≤2. Exclusions include ocular diseases, significant cardiovascular conditions (NYHA Grade II+ CHF, recent MI), Grade 2+ neuropathy, CNS metastases, and prior maytansine-based therapy.
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| Administration Dosage |
IV infusion once every 3 weeks until disease progression or unacceptable toxicity
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| Related Clinical Trial | |||||
| NCT Number | NCT00674947 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Study of BIIB015, a Humanized, IgG1, DM4-Conjugated, Anti-Cripto, Monoclonal Antibody, for the Treatment of Subjects With Relapsed or Refractory Solid Tumors | ||||
| Primary Endpoint |
The study aims to assess safety and determine the maximum-tolerated dose (MTD) of the investigational therapy, with ongoing monitoring throughout the trial duration.
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| Other Endpoint |
Key secondary objectives include evaluating pharmacokinetics (PK) and clinical activity, with continuous data collection to characterize drug behavior and therapeutic potential.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT00674947 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 study of B2B015, a humanized, IgG1, DM4-conjugated, anti-cripto, monoclonal antibody, for the treatment of subjects with relapsed or refractory solid tumors. | ||||
Discovered Using Cell Line-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 53.40% | High TDGF1 expression (TDGF1+++) | ||
| Method Description |
NCCIT cells were inoculated into 8-week old male athymic nude mice. MDA-MB-231 cells were inoculated into 7-week old female CB17 SCID mice. Calu-6,human non-small cell lung cancer cells (ATCC) were maintained in MEM Earless BSS/NEAA/10%FBS media without antibiotics and inoculated subcutaneously (SC) into the right flank of 9-week old female athymic nude mice. For the CT-3 tumour model,primary human colon tumour tissue was serially transplanted in vivo to establish a SC xenograft model. Cryopreserved tumour fragments were thawed and serially passaged SC in female SCID beige mice at 810 weeks old for two to five generations prior to implantation for studies.
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| In Vivo Model | MDA-MB-231 xenograft model | ||||
| In Vitro Model | Breast adenocarcinoma | MDA-MB-231 cells | CVCL_0062 | ||
References