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 |
iladatuzumab vedotin; DCDS0780A; RG-7986
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| Organization |
Roche (Top20 MNC) (Originator)
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| Drug Status |
Phase 1 (discontinued)
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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 |
MMAE
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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 |
Reactive Cysteines
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| Combination Type |
vedotin
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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 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] | ||||
| 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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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants have relapsed/refractory B-cell NHL (ECOG 0-1, adequate organ function), while exclusions include recent anticancer therapy (4 weeks for mAbs, 2 weeks for chemo/radiation), active CNS lymphoma, uncontrolled infections, HBV/HCV/HIV positivity, or significant comorbidities (e.g., diabetes with HbA1c ≥7.5%, Grade 2+ neuropathy).
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| Administration Dosage |
Participants will receive escalating doses of DCDS0780A as intravenous infusion as monotherapy on Day 1 of each 21-day cycle up to approximately 1 year or until disease progression or unacceptable toxicity (whichever comes first).
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| Related Clinical Trial | |||||
| NCT Number | NCT02453087 | Clinical Status | PHASE1 | ||
| 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 |
The study assesses DCDS0780A safety (AEs, dose-limiting toxicities), MTD/RP2D determination (Days 1-21), and pharmacokinetics (AUC, Cmax, CL, t½, Vss for total antibody, acMMAE, unconjugated MMAE) via intensive sampling across monotherapy/combination arms (21-day cycles, up to 1 year).
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| Other Endpoint |
Key efficacy endpoints include ORR (Lugano criteria), PFS, DOR, and B-cell recovery metrics, alongside immunogenicity (anti-drug antibodies) and pharmacodynamic markers (lymphocyte counts), all monitored over 24 months with standardized infusion protocols.
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References