Antibody Information
General Information of This Antibody
| Antibody ID | ANI0FXGPB |
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| Antibody Name | Anti-CD70 mAb |
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| Antibody Type | Monoclonal antibody (mAb) |
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| Antibody Subtype | Humanized IgG |
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| Antigen Name | CD70 antigen (CD70) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
AMG 172 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| 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
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| 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 | [1] | ||||
| 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.
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
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| 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 | [1] | ||||
| 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
|
||||
| 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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Anti-CD70-45 ADC [Investigative]
Revealed Based on the Cell Line Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Half Maximal Inhibitory Concentration (IC50) |
10.6 nM
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Negative CD70 expression (CD70-) | ||
| Method Description |
Cancer cell lines were incubated with compounds for 72 h. IC50 values were determined by quantitating viable cells using a CellTiter-Glo luminescent assay.
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| In Vitro Model | Lung small cell carcinoma | NCI-H187 cells | CVCL_1501 | ||
References