Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0GZGHN)
| ADC Name |
SAR566658
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| Synonyms |
SAR566658; ACT14884
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| Organization |
ImmunoGen (Top20 MNC) (Originator) (No Rights);Sanofi (Top20 MNC)
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| Drug Status |
Phase 2 (discontinued)
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| Drug-to-Antibody Ratio |
3.5
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| Structure |
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| Antibody Name |
huDS6
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Antibody Info | ||||
| Antigen Name |
Carbonic anhydrase 6 (CA6)
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Antigen Info | ||||
| Payload Name |
DM4
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
N-succinimidyl 4-(2-pyridyldithio) butanoate (SPDB)
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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| Combination Type |
ravtansine
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
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] | ||||
| Patients Enrolled |
Eligibility: Metastatic TNBC patients (≥18y, ECOG<2) with CA6-positive disease and 1-3 prior chemotherapy lines (must include anthracycline/taxane). Exclusions: active CNS metastases, prior maytansinoid/eribulin therapy, Grade ≥2 neuropathy, corneal disorders, CYP3A4 inhibitor use, or contraindications to ocular prophylaxis. Contraception required during/6 months post-treatment.
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| Administration Dosage |
Participants received SAR566658 90 milligram per square meter (mg/m^2) as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
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| Related Clinical Trial | |||||
| NCT Number | NCT02984683 | Clinical Status | PHASE2 | ||
| Clinical Description | Open-label Phase 2 Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer | ||||
| Primary Endpoint |
Primary endpoints include IMP-related safety findings (Grade ≥3 eye disorders/peripheral neuropathy or Grade ≥4 TEAEs per NCI CTCAE v4.03) during Cycle 1-2 (21-day cycles) and objective response rate (CR+PR per RECIST 1.1) assessed every 6 weeks until progression.
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| Other Endpoint |
Secondary outcomes comprise disease control rate (CR+PR+SD≥3 months), duration of response, PFS, TTP, treatment-emergent AEs/SAEs up to 30 days post-treatment, keratopathies incidence (with prophylactic ocular measures), and anti-drug antibody development over 3 treatment cycles.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligibility: CA6-positive solid tumor patients (≥15% tumor cell staining) without standard therapy options. Exclusions: ECOG≥2, organ dysfunction, unresolved toxicities (Grade>1), recent antitumor therapy (<3 weeks washout), pulmonary/cardiac comorbidities, corneal disorders, CYP3A inhibitor use, or midazolam contraindications (for specific cohort). Contraception required.
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| Administration Dosage |
SAR566658 will be administered by intravenous (IV) infusion according to three different schedules
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| Related Clinical Trial | |||||
| NCT Number | NCT01156870 | Clinical Status | PHASE1 | ||
| Clinical Description | Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion in Adult Patients With CA6-Positive and Refractory Solid Tumors | ||||
| Primary Endpoint |
Primary objectives include dose escalation to determine MTD of SAR566658 (3-week cycles) and evaluation of preliminary antitumor activity (assessed every 6 weeks), along with CYP3A enzyme interaction assessment using midazolam probe at Days 1 and 4.
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| Other Endpoint |
Secondary endpoints comprise comprehensive safety monitoring (NCI-CTCAE v4.03), PK profiling, immunogenicity assessment, antitumor response evaluation, CYP3A activity analysis (up to Cycle 2), and alternative dosing schedule safety (up to 2 years).
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02984683 | Clinical Status | Phase 1 | ||
| Clinical Description | Open-label phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic triple negative breast cancer. | ||||
| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT01156870 | Clinical Status | Phase 1 | ||
| Clinical Description | Dose escalation, safety and pharmacokinetic, first in man study, of SAR566658 administered as a single agent by intravenous infusion in adult patients with CA6-positive and refractory solid tumors. | ||||
References