Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0AZRNL
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| ADC Name |
Iladatuzumab vedotin
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| Synonyms |
DCDS 0780A; DCDS-0780A; DCDS0780A; RO-7032005
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| Organization |
F. Hoffmann-La Roche Ltd.; Roche Holding AG
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| Drug Status |
Phase 1
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| Indication |
In total 1 Indication(s)
Non Hodgkin lymphoma [ICD11:2B33]
Phase 1
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| Drug-to-Antibody Ratio |
2
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| Structure |
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| Antibody Name |
Iladatuzumab
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Antibody Info | ||||
| Antigen Name |
B-cell antigen receptor complex-associated protein beta chain (CD79B)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Mc-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Site-specific conjugation through the engineered cysteine (THIOMAB).
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| Combination Type |
Vedotin
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| Puchem SID | ||||||
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] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
46.67%
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| Patients Enrolled |
B-non Hodgkin lymphoma (NHL) that had relapsed after or failed to respond to at least one prior treatment regimen and for which no suitable therapy of curative intent or higher priority existed.
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| Administration Dosage |
The phase Ia, starting dose of 0.30 mg/kg administered intravenously once every 3 weeks (Q3W; 1 cycle = 21 days); The phase Ib portion evaluated DCDS0780A in dose-escalation cohorts starting at one dose level below that tolerated by completed monotherapy cohorts, and in combination with a fixed dose of rituximab (375 mg/m2); up to approximately 1 year or until disease progression or unacceptable toxicity.
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| Related Clinical Trial | |||||
| NCT Number | NCT02453087 | Clinical Status | Phase 1 | ||
| Clinical Description | An open-label, multicenter, phase 1/1b dose escalation study evaluating the pharmacokinetics, safety, tolerability, and preliminary efficacy of DCDS0780A, alone or in combination with rituximab, or obinutuzumab, in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. | ||||
| Primary Endpoint |
Response rate in all-treated patients (N=60) was 46.67% (n=28), including 17 complete responses (28.33%) and 11 partial responses (18.33%). The median duration of response (15.20 months) was the same for all responders (n=28) and patients with DLBCL (n=20).
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| Other Endpoint |
The median PFS for all patients on study (N =60) was 4.40 months [95% CI,2.60-13.20], and 3.90 months (95% CI,2.40-9.50) for patients with DLBCL (n=41); PFS for pooled subgroups are indicated. The median DoR for the 28 responders among all patients was 15.20 months (95% CI,8.40-N.E.).
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References
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