Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0XLJJW
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| ADC Name |
IMGN388
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| Synonyms |
IMGN388
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| Organization |
ImmunoGen (Top20 MNC) (Originator);Janssen Biotech (Top20 MNC) (No Rights)
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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 |
Intetumumab
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Antibody Info | ||||
| Antigen Name |
Integrin alpha-V (ITGAV)
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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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| Breast cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Melanoma |
1 Trials
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| Ovarian cancer |
1 Trials
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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
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] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT00721669 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 dose-escalation study of IMGN388 in patients with solid tumors. | ||||
| Primary Endpoint |
Five patients (breast,prostate,neuroendocrine,and 2 NSCLC) treated at doses 45 mg/m2 have acheived stable disease for 4 cycles.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Advanced solid tumors.
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| Administration Dosage |
Doses ranging from 5 to 80 mg/m2, every 3 weeks, IV.
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| Related Clinical Trial | |||||
| NCT Number | NCT00721669 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 dose-escalation study of IMGN388 in patients with solid tumors. | ||||
| Primary Endpoint |
No evidence of activity was observed at the lowest doses (45 mg/m2) evaluated.
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| Other Endpoint |
No evidence of human anti-human antibody formation (data available for doses up to 60 mg/m2.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients must be ≥18 years with histologically confirmed metastatic/unresectable alphav integrin-positive tumors (melanoma, breast, lung, or ovarian cancer in expansion phase, confirmed by IHC) and measurable disease. Key requirements include ECOG ≤2, adequate organ function (ANC ≥1500/mm <sup>3</sup>, platelets ≥100K/mm <sup>3</sup>, hepatic/renal parameters ≤1.5-2.5×ULN), and contraception use. Exclusions cover active CNS metastases, grade ≥1 residual toxicity, recent anticancer therapy (<4 weeks), uncontrolled infections, NYHA class III/IV cardiac disease, HIV/Hepatitis coinfection, pregnancy, or conditions compromising safety per investigator judgment. Patients will undergo scheduled safety and survival follow-ups post-treatment.
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| Administration Dosage |
26 patients received a total of 52 cycles of IMGN388 at doses ranging from 5 to 80 mg/m2.
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| Related Clinical Trial | |||||
| NCT Number | NCT00721669 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Dose-Escalation Study of IMGN388 in Patients With Solid Tumors | ||||
| Primary Endpoint |
The study evaluates safety and pharmacokinetics of the investigational agent during the treatment period, focusing on identifying adverse events, dose tolerability, and drug metabolism characteristics.
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| Other Endpoint |
Key secondary assessments include pharmacodynamic effects, immunogenicity potential, and tumor response evaluation (e.g., objective response rate, disease control) in patients with advanced solid tumors during the study timeframe.
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References