Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0YHPUE
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| 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); Macrophage-stimulating protein receptor (MST1R)
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Antigen Info | ||||
| Payload Name |
MMAE
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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 Cysteines
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| Combination Type |
vedotin
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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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| Unspecific solid tumor |
1 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 |
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