Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0FJCZS
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| ADC Name |
AMG 172
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| Synonyms |
AMG 172
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| Organization |
ImmunoGen (Top20 MNC) (Originator);Amgen (Top20 MNC)
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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 |
Anti-CD70 mAb
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Antibody Info | ||||
| Antigen Name |
CD70 antigen (CD70)
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Antigen Info | ||||
| Payload Name |
DM1
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Succinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate (SMCC)
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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| Combination Type |
emtansine
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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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| Kidney cancer |
1 Trials
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General Information of The ADMET Data Related to This ADC(2027 Update)
Excretion
| Standard Type | Value | Units | Description | Reference |
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| Clearance (CL) | 9.45 | mL/h |
AMG 172 CL was estimated to be 9.45 mL/hr in a typical human (70 kg) based on species-invariant time scaling methods.
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[1] |
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] | ||||
| Efficacy Data | stable disease (SD) |
16.20%
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| Patients Enrolled |
Eligible subjects require clear cell RCC refractory to ≥2 prior therapies (including a TKI) with measurable disease (RECIST 1.1), ECOG ≤1, adequate hematologic (ANC ≥1.5x10<sup>9</sup>/L, platelets ≥100x10<sup>9</sup>/L) and hepatic function (AST/ALT <3xULN). Exclusions encompass CNS metastases, bleeding disorders, significant cardiac comorbidities (recent MI, CHF NYHA >II, QTcF >470ms), uncontrolled HTN, or active HBV/HCV/HIV infections.
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| Administration Dosage |
The study was conducted in two parts for dose exploration and dose expansion on a biweekly dosing schedule. AMG 172 doses of 0.15, 0.3, 0.6, 1.2, 1.6, 1.8, and 2.4 mg/kg were studied in the dose-exploration phase.
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| Related Clinical Trial | |||||
| NCT Number | NCT01497821 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma | ||||
| Primary Endpoint |
Primary safety assessments include ≥Grade 3 CTCAE adverse events and clinically significant lab/ECG changes monitored for 28 days post-enrollment. Pharmacokinetic parameters (Cmax, AUC, t½) are evaluated across 12 timepoints within 8 weeks. The MTD will be determined for two dosing schedules (biweekly/triweekly) with tumor response (RECIST 1.1) assessed over 3 years.
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| Other Endpoint |
Secondary endpoints include immunogenicity (anti-drug antibodies over 1 year), non-MTD cohort ORR (RECIST 1.1), and clinical benefit via DOR, all evaluated through 3 years.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | progressive disease (PD) |
35.10%
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| Patients Enrolled |
Eligible subjects require clear cell RCC refractory to ≥2 prior therapies (including a TKI) with measurable disease (RECIST 1.1), ECOG ≤1, adequate hematologic (ANC ≥1.5x10<sup>9</sup>/L, platelets ≥100x10<sup>9</sup>/L) and hepatic function (AST/ALT <3xULN). Exclusions encompass CNS metastases, bleeding disorders, significant cardiac comorbidities (recent MI, CHF NYHA >II, QTcF >470ms), uncontrolled HTN, or active HBV/HCV/HIV infections.
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| Administration Dosage |
The study was conducted in two parts for dose exploration and dose expansion on a biweekly dosing schedule. AMG 172 doses of 0.15, 0.3, 0.6, 1.2, 1.6, 1.8, and 2.4 mg/kg were studied in the dose-exploration phase.
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| Related Clinical Trial | |||||
| NCT Number | NCT01497821 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma | ||||
| Primary Endpoint |
Primary safety assessments include ≥Grade 3 CTCAE adverse events and clinically significant lab/ECG changes monitored for 28 days post-enrollment. Pharmacokinetic parameters (Cmax, AUC, t½) are evaluated across 12 timepoints within 8 weeks. The MTD will be determined for two dosing schedules (biweekly/triweekly) with tumor response (RECIST 1.1) assessed over 3 years.
Click to Show/Hide
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| Other Endpoint |
Secondary endpoints include immunogenicity (anti-drug antibodies over 1 year), non-MTD cohort ORR (RECIST 1.1), and clinical benefit via DOR, all evaluated through 3 years.
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| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Partial Response (PR) |
5.40%
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| Patients Enrolled |
Eligible subjects require clear cell RCC refractory to ≥2 prior therapies (including a TKI) with measurable disease (RECIST 1.1), ECOG ≤1, adequate hematologic (ANC ≥1.5x10<sup>9</sup>/L, platelets ≥100x10<sup>9</sup>/L) and hepatic function (AST/ALT <3xULN). Exclusions encompass CNS metastases, bleeding disorders, significant cardiac comorbidities (recent MI, CHF NYHA >II, QTcF >470ms), uncontrolled HTN, or active HBV/HCV/HIV infections.
Click to Show/Hide
|
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| Administration Dosage |
The study was conducted in two parts for dose exploration and dose expansion on a biweekly dosing schedule. AMG 172 doses of 0.15, 0.3, 0.6, 1.2, 1.6, 1.8, and 2.4 mg/kg were studied in the dose-exploration phase.
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| Related Clinical Trial | |||||
| NCT Number | NCT01497821 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma | ||||
| Primary Endpoint |
Primary safety assessments include ≥Grade 3 CTCAE adverse events and clinically significant lab/ECG changes monitored for 28 days post-enrollment. Pharmacokinetic parameters (Cmax, AUC, t½) are evaluated across 12 timepoints within 8 weeks. The MTD will be determined for two dosing schedules (biweekly/triweekly) with tumor response (RECIST 1.1) assessed over 3 years.
Click to Show/Hide
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| Other Endpoint |
Secondary endpoints include immunogenicity (anti-drug antibodies over 1 year), non-MTD cohort ORR (RECIST 1.1), and clinical benefit via DOR, all evaluated through 3 years.
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References