Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0VRBPJ
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| ADC Name |
BAY 79-4620
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| Synonyms |
BAY 79-4620; BAY79-4620; BAY 794620; MN-IC
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| Organization |
Bayer (Top20 MNC) (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Antibody Name |
3ee9
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Antibody Info | ||||
| Antigen Name |
Carbonic anhydrase 9 (CA9)
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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 |
Val-Cit dipeptide linker
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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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 |
2 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 | NCT01065623 | Clinical Status | Phase 1 | ||
| Clinical Description | An open label phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and maximum tolerated dose of BAY79-4620 administered as an intravenous infusion once every 2 weeks in patients with advanced solid tumors. | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT01028755 | Clinical Status | Phase 1 | ||
| Clinical Description | An open label phase 1 study to evaluate the safety, tolerability, pharmacokinetics and maximum tolerated dose of BAY79-4620 in patients with advanced solid tumors. | ||||
| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible participants must be ≥18 years with ECOG 0-2, ≥12-week life expectancy, confirmed advanced solid tumors refractory to standard therapy, and evaluable disease. Required lab values include: Hgb>10, ANC≥1500, platelets≥100K, bilirubin≤1.5xULN, ALT/AST≤2.5xULN (5x if liver mets), creatinine≤1.5xULN. Exclusions include significant cardiac disease (CHF III/IV, recent MI, arrhythmias, LVEF<40%), pancreatic abnormalities, uncontrolled HTN, active CNS mets (<6mos stable), renal failure, active HBV/HCV/HIV, grade≥3 infections, unhealed wounds, drug allergies, or other malignancies (except cured cancers >3yrs prior).
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| Administration Dosage |
BAY79-4620 will be administered as 1 hour IV infusion. Dose escalation will be dependent on any dose limiting toxicities
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| Related Clinical Trial | |||||
| NCT Number | NCT01028755 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
The study will evaluate the safety profile, tolerability, and determine the maximum tolerated dose of BAY79-4620 over two years, while simultaneously characterizing the pharmacokinetics of the drug and its key metabolites throughout the same duration.
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| Other Endpoint |
Comprehensive biomarker assessments will be conducted, along with tumor response evaluations (following standard criteria), and immunogenicity testing - all assessed continuously over the two-year study period as key secondary endpoints.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients must be ≥18 years old with ECOG 0-2, ≥12-week life expectancy, and advanced refractory solid tumors (histologically confirmed) who either lack standard options or decline standard therapy, with evaluable disease and adequate organ function. Key exclusions include significant cardiac disease (CHF Class III/IV, recent MI, unstable angina), uncontrolled hypertension (>160/95 mmHg), untreated CNS metastases, severe renal impairment, active HBV/HCV/HIV infections requiring treatment, serious unhealed wounds, recent major surgery/trauma, or anticancer treatments within protocol-specified washout periods.
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| Administration Dosage |
1-hour infusion every 14 days. Starting dose will be 0.15 mg/ kg and dose will be escalated dependent on any dose limiting toxicities
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| Related Clinical Trial | |||||
| NCT Number | NCT01065623 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open Label Phase I Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY79-4620 Administered as an Intravenous Infusion Once Every 2 Weeks in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
The trial will monitor adverse events for approximately 3 years while characterizing the pharmacokinetics of BAY79-4620 at the end of cycle 2 (14-day cycles).
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| Other Endpoint |
Biomarker patterns, tumor response outcomes, and immunogenicity will be systematically evaluated throughout the study's 3-year duration.
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References