Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0FXFDD
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| ADC Name |
RG7600
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| Synonyms |
RG7600; DMOT4039A; DMOT-4039A
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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 |
3.5
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| Structure |
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| Antibody Name |
H7D9.v3
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Antibody Info | ||||
| Antigen Name |
Mesothelin (MSLN)
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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 |
Random 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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| Ovarian cancer |
1 Trials
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General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
| Standard Type | Value | Units | Description | Reference |
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| Maximum Observed Concentration (Cmax) | 39 | ug/mL |
Pharmacokinetic parameters for ADC in cycle 1 at 2.4 mg/kg.
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| Area Under the Concentration-Time Curve (AUC) | 162 | day*ug/mL |
Pharmacokinetic parameters for ADC in cycle 1 at 2.4 mg/kg.
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Distribution
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 162 | day*ug/mL |
Pharmacokinetic parameters for ADC in cycle 1 at 2.4 mg/kg.
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Metabolism
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 162 | day*ug/mL |
Pharmacokinetic parameters for ADC in cycle 1 at 2.4 mg/kg.
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Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 162 | day*ug/mL |
Pharmacokinetic parameters for ADC in cycle 1 at 2.4 mg/kg.
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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 | [2] | ||||
| Patients Enrolled |
Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer
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| Administration Dosage |
Injection of 89Zr-MMOT0530A followed by 2 or 3 PET scans at different time points
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| Related Clinical Trial | |||||
| NCT Number | NCT01832116 | Clinical Status | PHASE1 | ||
| Clinical Description | 89Zr-MMOT0530A PET Imaging in Patients With Unresectable Pancreatic or Platinum-resistant Ovarian Cancer Before Treatment With DMOT4039A. A Separate Study to the Phase I Study Protocol DMO4993g | ||||
| Primary Endpoint |
The in vivo biodistribution measured in SUV values and organ pharmacokinetics (PK) of 89Zr-MMOT0530A [Time Frame: Approximately 1 year]
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| Other Endpoint |
The 89Zr-MMOT0530A tumor uptake measured in SUV related to the response to DMOT4039A therapy according to RECISt 1.1 criteria [Time Frame: Approximately 1 year], Number of patients with adverse events after 89Zr-MMOT0530A injection as a measure of safety and tolerability [Time Frame: Approximately 1 year]
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| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer.
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| Administration Dosage |
Participants in different cohorts will receive DMOT4039A at various escalating dose levels, starting with 0.2 milligrams per kilogram (mg/kg), as intravenous infusion every 3 weeks (Q3W) to determine the maximum tolerated dose (MTD) of DMOT4039A for until disease progression, loss of clinical benefit or unacceptable toxicity, whichever occurred first (up to approximately 2.5 years
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| Related Clinical Trial | |||||
| NCT Number | NCT01469793 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I, Open Label Study of the Safety and Pharmacokinetics of Escalating Doses of DMOT4039A in Patients With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer | ||||
| Primary Endpoint |
Maximum Tolerated Dose (MTD) of DMOT4039A, Number of Participants With Dose-Limiting Toxicities (DLTs), Recommended Phase 2 Dose (RP2D) of DMOT4039A.
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| Other Endpoint |
Pharmacokinetics: area under the concentration-time curve (AUC), Serum anti-therapeutic antibody levels, Objective response (complete response or partial response), tumor assessments according to RECIST criteria, Duration of response, Progression-free survival.
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References