Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0YHPUE)
| ADC Name |
RC108
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| Synonyms |
RC108
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| Organization |
RemeGen (Originator)
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| Drug Status |
Phase 2 (discontinued)
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Anti-c-Met antibody
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Antibody Info | ||||
| Antigen Name |
Hepatocyte growth factor receptor (MET)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Mc-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
vedotin
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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 |
The study emphasizes rigorous safety (QTc monitoring, pregnancy prevention) and biomarker-driven enrollment (c-Met positivity), targeting refractory digestive cancers with comprehensive efficacy-safety profiling over 24 months (OS up to 5 years).
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05628857 | Clinical Status | PHASE2 | ||
| Clinical Description | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of RC108 for Injection in the Treatment of Patients With c-Met-positiveAdvanced Digestive System Malignant Tumor | ||||
| Primary Endpoint |
Efficacy endpoints include ORR (CR+PR) and DOR per RECIST 1.1 along with disease control metrics (DCR, TTP, PFS) over 24 months. Safety assessments track AEs, while pharmacokinetics (AUC, Cmax, Tmax, half-life) are monitored throughout the treatment period.
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| Other Endpoint |
Eligible participants (18-75 years) require c-Met-positive advanced/metastatic digestive system malignancies, ECOG 0-1, adequate organ function, and measurable lesions per RECIST 1.1. Key exclusions involve uncontrolled effusions, unresolved Grade ≥2 toxicities, recent oncology treatments/surgeries, active infections (HIV/HBV/HCV), or CNS metastases.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Exclusions: uncontrolled effusions, active infections (HBV/HCV/HIV), recent oncology treatments (≤4 weeks), untreated brain metastases (treated/stable≥3 months allowed), prior HGF/MET/PD-1/L1 inhibitors (Cohort-specific), QTc>450ms, ILD, or other malignancies within 5 years.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05821933 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | An Open Single-arm Study to Evaluate the Safety, Tolerability, Efficacy of RC108 in Combination With Furmonertinib and Toripalimab in Patients With Advanced EGFR-mutated NSCLC Ib/II Study | ||||
| Primary Endpoint |
This study evaluates RC108 combined with Furmonertinib ± Toripalimab in advanced NSCLC patients with EGFR mutations (exon 19 del/L858R/T790M/etc.) and MET overexpression (IHC 1+/2+/3+), measuring efficacy (ORR, DCR, PFS, DOR up to 24 months), safety (DLTs/MTD in 21-day cycles), and PK parameters.
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| Other Endpoint |
Key inclusion: Age 18-75, ECOG 0-1, adequate organ function (ANC≥1.5×109/L, platelets≥100×109/L, LVEF≥50%), EGFR-TKI progression history, measurable lesions (RECIST 1.1), and MET/PD-L1 testing. Pregnancy prevention required.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible participants (18-70 years) must have c-Met-positive advanced solid tumors, ECOG 0-1, measurable lesions, and adequate organ function (ANC≥1.5×10<sup>9</sup>/L, platelets≥100×10<sup>9</sup>/L, LVEF≥50%). Exclusions: uncontrolled effusions, active infections (HBV/HCV/HIV), CNS metastases, prior anticancer therapy within 4 weeks, or unresolved CTCAE Grade ≥2 toxicity (excluding alopecia). Contraception is mandated.
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| Administration Dosage |
Participants will be allocated to one of the following dose groups: 0.1, 0.3, 0.9, 1.5, 2.0, 2.5, and 3.0mg/kg, and receive a treatment of RC108-ADC followed by 21 days of dose limited toxicity (DLT) observation period.
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| Related Clinical Trial | |||||
| NCT Number | NCT04617314 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Effect of RC108-ADC for Injection in Subjects with C-Met Positive Advanced Malignant Solid Tumors | ||||
| Primary Endpoint |
The study monitors safety through AE reporting per NCI-CTCAE v4.03 until 28 days post-treatment and establishes MTD (≥2/6 patients experiencing DLTs within 21 days of first RC108 dose). Pharmacokinetics of RC108 (TAb/ADC/MMAE) are analyzed via serial blood sampling across doses to determine Cmax, Tmax, AUC, Ctrough, t1/2, and CL, alongside immunogenicity (anti-RC108 antibodies).
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| Other Endpoint |
Efficacy endpoints include ORR (CR+PR) and median PFS per RECIST 1.1 over 24 months, with tumor assessments tracking progression (≥20% target lesion growth or new lesions). PK blood draws occur pre-dose and up to 504h post-infusion for comprehensive exposure analysis.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients (18-81 years) must have PV diagnosed ≤5 years, meet WHO criteria, and be on hydroxyurea, with normal organ function (bilirubin/ALT/AST ≤2×ULN, creatinine ≤1.5×ULN). Exclusions: clopidogrel/aspirin intolerance, anticoagulant use, pregnancy, major bleeding history, NYHA ≥II CHF, MELD ≥8, or CYP3A4 inhibitors. Women of childbearing potential require contraception.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT00940784 | Clinical Status | PHASE2 | ||
| Clinical Description | MPD-RC 108: Phase II, Randomized, Double-Blind, Placebo Controlled International Study of Clopidogrel and Aspirin for the Treatment of Polycythemia Vera | ||||
| Primary Endpoint |
This study evaluates the safety and efficacy of clopidogrel plus aspirin in polycythemia vera patients over 2 years, focusing on high-risk individuals with prior thrombotic events (stroke, MI, or VTE) and WHO-confirmed PV (Hb >18.5 g/dL [men]/16.5 g/dL [women], JAK2V617F mutation, and trilineage hyperplasia).
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References