Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0YZGPN
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| ADC Name |
CDX-014
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| Synonyms |
CDX 014; CR 014-vcMMAE
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| Organization |
CuraGen Corp.; Celldex Therapeutics, Inc.; Amgen, Inc.
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| Drug Status |
Phase 2
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| Indication |
In total 2 Indication(s)
Ovarian cancer [ICD11:2C73]
Phase 2
Renal cell carcinoma [ICD11:2C90]
Terminated in phase 2
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| Drug-to-Antibody Ratio |
4.5
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| Antibody Name |
Anti-TIM1 CDX-014 mAb
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Antibody Info | ||||
| Antigen Name |
Hepatitis A virus cellular receptor 1 (HAVCR1)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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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 conjugation through reduced inter-chain cysteines.
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| Combination Type |
Vedotin
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| Puchem SID | ||||||
| TTD ID | ||||||
| ChEBI ID | ||||||
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Discovered Using Cell Line-derived Xenograft Model
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 | Partial Response (PR) |
6.20%
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| Patients Enrolled |
Advanced clear cell or papillary renal cell carcinoma (RCC) who experienced progression after at least two lines of systemic therapy, including at least one TKI were included; Additional main inclusion criteria included measurable disease by Response Criteria in Solid Tumors (RECIST) 1.1 criteria, a Karnofsky performance status 70%, and adequate renal, hepatic, and hematological laboratory values.
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| Administration Dosage |
Intravenously at doses ranging from 0.15 to 2.00 mg/kg every 2 or 3 weeks until progression or unacceptable toxicity.
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| Related Clinical Trial | |||||
| NCT Number | NCT02837991 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase l open-label, dose escalation and cohort expansion study, to assess the safety and activity of the antibody-drug conjugate CDX-014 in advanced or metastatic renal cell carcinoma (RCC) and advanced or metastatic ovarian clear cell carcinoma (OCCC). | ||||
| Primary Endpoint |
One patient (6.20%) treated at 0.3 mg/kg every 3 weeks exhibited PR as best overall response,ongoing after 17 months on therapy; this patient had been on single agent PD-1 inhibition prior to initiating therapy with CDX-014. Five patients (31.00%) exhibited clinical benefit from CDX-014. PFS and OS were 2.70 months (95%CI 1.2-8.0) and 12.6 months (95%CI 5.7-12.6),respectively.
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| Other Endpoint |
Partial response (PR) = 6.00% of one patient treated at 0.30 mg/kg every 3 weeks as best overall response, clinical benefit from CDX-014 of five patients = (31.25%) exhibited of at least 6 months. PFS = 2.7 months (95%CI, 1.20-8.00) ,OS =12.6 months (95%CI, 5.70-12.60).
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Discovered Using Cell Line-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 20.00% | Positive TIM1 expression (TIM1+++/++) | ||
| Method Description |
Anti-TIM-1-vcMMAE (CDX-014=300 g), CDX-014 inhibited the increase in tumor volumes relative to saline control treatment.
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| In Vivo Model | IGROV-1 xenograft mouse models | ||||
| In Vitro Model | Ovarian endometrioid adenocarcinoma | IGROV-1 cells | CVCL_1304 | ||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 21.00% | Positive TIM1 expression (TIM1+++/++) | ||
| Method Description |
Anti-TIM-1-vcMMAE (CDX-014=300 g).
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| In Vivo Model | A549 xenograft mouse models | ||||
| In Vitro Model | Lung adenocarcinoma | A-549 cells | CVCL_0023 | ||
| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 22.90% | Positive TIM1 expression (TIM1+++/++) | ||
| Method Description |
Anti-TIM-1-vcMMAE (CDX-014=300 g).
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| In Vivo Model | Caki-1 xenograft mouse model | ||||
| In Vitro Model | Clear cell renal cell carcinoma | Caki-1 cells | CVCL_0234 | ||
| Experiment 4 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 40.50% | Positive TIM1 expression (TIM1+++/++) | ||
| Method Description |
Extended dosing of CDX-014 ADC in the A549 tumor model. Three cycles of four doses of CDX-014 prolong the inhibition of tumor growth.
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| In Vivo Model | A549 xenograft mouse models | ||||
| In Vitro Model | Lung adenocarcinoma | A-549 cells | CVCL_0023 | ||
References
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