Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0WWZAS
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| ADC Name |
SYS6010
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| Synonyms |
SYS6010; CPO301
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| Organization |
CSPC Pharmaceutical Group (Originator)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
Anti-EGFR antibody
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Antibody Info | ||||
| Antigen Name |
Epidermal growth factor receptor (EGFR)
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Antigen Info | ||||
| Payload Name |
JS-1
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Mc-Gly-Gly-Phe-Gly
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
JSSW-001
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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 |
2 Trials
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1 Trials
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| Lung cancer |
2 Trials
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2 Trials
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| Oesophageal cancer |
1 Trials
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| Unspecific solid tumor |
3 Trials
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5 Trials
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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] | ||||
| Patients Enrolled |
Patients with EGFR mutant locally advanced or metastatic NSCLC
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | CTR20243230 | Clinical Status | Phase 3 | ||
| Clinical Description | A randomized, open, multicenter, phase I/III trial to evaluate the safety and efficacy of SYS6010 in combination with ocitinib in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Age ≥18 years, Patients with histologically confirmed locally advanced or metastatic solid tumors who have disease progression, intolerance to prior therapy, are ineligible for available therapies, or refuse standard of care therapy in the metastatic setting.In Part A, patients with solid tumors including but not limited to NSCLC (adenocarcinoma and squamous cell carcinoma), breast cancer, KRAS-wild type colorectal cancer, and head & neck cancer based on previous biopsy result.In Part B, Cohort 1 will exclusively include NSCLC patients with documented EGFR mutations based on previous biopsy result and Cohort 2 will be patients with other cancer (s) suggested to have sensitivity to CPO301 in Part A.
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| Administration Dosage |
Participants receive escalating doses of CPO301 of 0.6 mg/kg, 1.8mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.4 mg/kg and 8 mg/kg administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT05948865 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO301, an EGFR-Targeting Antibody-Drug Conjugate, in Adult Patients With Advanced or Metastatic Solid Tumors | ||||
| Primary Endpoint |
To determine the dose to be used in Part B (RP2D), Safety and tolerability at RP2D of CPO301 as monotherapy.
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| Other Endpoint |
Pharmacokinetics (PK), Expression of anti-drug antibody (ADA), Efficacy assessment.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
This study enrolled patients aged ≥18 years (Phase 1b/Phase 2: breast cancer with no tumor type restriction during combination dose escalation), requiring EGFR-positive tumor tissue per central lab, at least one measurable extracranial lesion (RECIST v1.1; waived during Phase 1b dose escalation), ECOG 0-1, life expectancy ≥3 months, adequate hematologic/renal/hepatic/coagulation function within 7 days pre-treatment, agreement to use contraception until 6 months post-treatment, and signed informed consent.
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| Administration Dosage |
SYS6010 injection 3.2 mg/kg or 3.6 mg/kg, intravenous drip, Q2W
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| Related Clinical Trial | |||||
| NCT Number | NCT06775236 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of SYS6010 as a Monotherapy or in Combination With SYH2051 Compared to Investigator's Choice Chemotherapy in Patients With EGFR-Expressing Advanced Unresectable or Metastatic Solid Tumors, Including But Not Limited to Breast Cancer | ||||
| Primary Endpoint |
Dose-limiting toxicity (DLT) occurrence and incidence, Adverse events (AE) occurrence and incidence, Objective response rate (ORR) per RECIST v1.1.
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| Other Endpoint |
Disease control rate (DCR) per RECIST 1.1 , Duration of response (DoR) per RECIST 1.1, Progression free survival (PFS) per RECIST 1.1, Overall survival (OS), PK parameters of toxin-bound antibody, Description :total antibody and free toxin (JS-1) after single and continuous administration of SYS6010, PK parameters after single and multiple administrations of SYH2051.
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References