Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0GZGHN
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| 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 | ||||
| Therapeutic 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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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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| Breast cancer |
1 Trials
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| Unspecific solid tumor |
1 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 | 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 2 Reporting the Activity Date of This ADC | [2] | ||||
| 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. | ||||
| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| 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 4 Reporting the Activity Date of This ADC | [4] | ||||
| 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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References