Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0CAEXH
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| ADC Name |
Ciletatug vedotin
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| Synonyms |
RC118; RC118-ADC
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| Organization |
RemeGen (Originator)
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| Drug Status |
Phase 1/2
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| Drug-to-Antibody Ratio |
3.5-4.5
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| Structure |
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| Antibody Name |
Ciletatug
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Antibody Info | ||||
| Antigen Name |
Claudin-18.2 (CLDN18.2)
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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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| Special Approval(s) |
Orphan drug (FDA)
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2027 Update
The indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||||
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| Unspecific solid tumor |
1 Trials
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1 Trials
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| Oesophageal cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Gastric cancer |
1 Trials
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| Pancreatic cancer |
1 Trials
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| Biliary tract cancer |
1 Trials
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| Ovarian cancer |
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 |
Eligible patients (18-75 years, ECOG 0-1) must have unresectable/metastatic Claudin 18.2-positive tumors refractory to standard therapy, measurable disease per RECIST v1.1, and adequate organ function (ANC≥1.5×10<sup>9</sup>/L, platelets≥100×10<sup>9</sup>/L, bilirubin≤1.5×ULN). Key exclusions include active HBV/HCV/HIV, uncontrolled comorbidities (cardiac, CNS metastases, grade≥2 neuropathy), recent antitumor therapy (<4 weeks), immunosuppression, or third-space effusions; reproductive-age patients require contraception compliance. Investigators may exclude participants deemed unsuitable for protocol adherence.
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| Administration Dosage |
Part A (Dose Escalation): RC118 will be administered through IV infusion at the various dose levels, including 0.25, 0.5, 1.0, 1.5, 2, 2.5, and 3 mg/kg, 1-12 subjects for each dose level. Part B (Dose Confirmation): RC118 will be administered at up to two dose levels, which is equal or lower than MTD/MAD, through IV infusion. Each dose level contains 3-6 subjects.
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| Related Clinical Trial | |||||
| NCT Number | NCT04914117 | Clinical Status | PHASE1 | ||
| Clinical Description | Phase 1, First-in-Human, Multicentre, Open-label Study of RC118 for Injection in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours | ||||
| Primary Endpoint |
The primary objectives include determining the maximum tolerated dose (MTD)/maximum administered dose (MAD) based on dose-limiting toxicities (DLTs) graded per NCI-CTCAE v5.0 over 18 months, with RP2D selection informed by safety committee review, while adverse events will be monitored throughout the study duration to assess treatment tolerability.
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| Other Endpoint |
Secondary efficacy endpoints encompass ORR (RECIST v1.1), PFS, DCR, and DOR, all evaluated over 18 months, alongside pharmacokinetic analyses (Cmax, AUC, Tmax of RC118/MMAE) and immunogenicity assessment (anti-drug antibody incidence) to characterize therapeutic response, drug exposure, and immunogenic potential.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants (18-75 years, ECOG 0-1) must have CLDN18.2-positive unresectable/metastatic gastric/GEJ/pancreatic cancers refractory to standard therapy with measurable lesions (RECIST v1.1), adequate organ function (ANC≥1.5×10<sup>9</sup>/L, platelets≥100×10<sup>9</sup>/L), and commit to contraception. Exclusions: active HBV/HCV/HIV, prior CLDN18.2 therapy, uncontrolled comorbidities (CNS metastases, QTc>480ms, NYHA 3-4 heart failure), recent anti-tumor treatment (<4 weeks), or pregnancy/breastfeeding. Investigator discretion applies for borderline cases.
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| Administration Dosage |
Participants will be allocated to one of the following dose groups: 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3.0mg/kg, and receive a treatment of RC118-ADC followed by 14 days of dose limited toxicity (DLT) observation period.
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| Related Clinical Trial | |||||
| NCT Number | NCT05205850 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | An Open, Multi-center Phase I/IIa Clinical Study of RC118 for Injection in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors with Positive Expression of Claudin 18.2 | ||||
| Primary Endpoint |
This study evaluates dose-limiting toxicity (DLT) within 28 days post-initial RC118 treatment (NCI-CTCAE v5.0-graded) and monitors adverse events (AEs) from consent through 28 days post-treatment to define safety, while assessing objective response rate (ORR) over 15 months by RECIST v1.1 (CR+PR).
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| Other Endpoint |
Secondary outcomes include disease control rate (DCR; CR+PR+SD), progression-free survival (PFS), duration of response (DOR) over 15 months, pharmacokinetics (Tmax), immunogenicity (ADA incidence), and overall survival (OS; up to 2 years) to comprehensively characterize therapeutic efficacy, drug exposure, and immune response.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients (18-75 years, ECOG 0-1) have Claudin18.2-positive metastatic gastric/GEJ adenocarcinoma refractory to ≤2 prior therapies, measurable lesions (RECIST v1.1), and adequate organ function. Key exclusions: active HBV/HCV/HIV, prior CLDN18.2/MMAE-based therapies, unstable brain metastases, QTc>450/470ms (M/F), uncontrolled comorbidities (NYHA 3-4 heart failure, autoimmune diseases requiring systemic treatment), or recent antitumor therapy (≤4 weeks). Phase 2 excludes patients with prior immune checkpoint inhibitor discontinuation due to toxicity or recent PD-1/PD-L1/VEGFR-targeted therapy.
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| Administration Dosage |
Participants receive RC118- ADC (dose A or dose B) Q2W and Toripalimab (fixed dose) Q3W. Referring to the results of the Part A, an extension cohort using RC118 plus Toripalimab /RC148 will be established.
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| Related Clinical Trial | |||||
| NCT Number | NCT06038396 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC118 in Combination with Toripalimab / RC148 for Patients with Claudin 18.2-Positive, Locally Advanced Unresectable or Metastatic Malignant Solid Tumors | ||||
| Primary Endpoint |
This Phase 1/2 study evaluates RC118+Toripalimab's safety (DLTs in first 21 days, AE/SAE incidence over 15 months) and establishes MTD/RP2D within 12 months; Phase 2 focuses on ORR (RECIST v1.1-confirmed CR/PR) over 15 months.
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| Other Endpoint |
Secondary efficacy metrics include DCR (CR+PR+SD), PFS, DOR, and OS (all 15-month endpoints); pharmacokinetics (RC118/MMAE peak/trough levels) and immunogenicity (ADA incidence/timing) are assessed to characterize drug exposure and immune responses.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients (≥18 years) must have WHO-confirmed primary/secondary myelofibrosis (MF-2+, DIPSS intermediate-2/high risk), ECOG 0-2, and platelets ≥25×10<sup>9</sup>/L; exclusions: prior TGF-beta inhibitors (e.g., galunisertib), active cardiovascular disease (uncontrolled hypertension, NYHA III-IV), active infections, or pregnancy. Women of childbearing potential require contraception. Organ function thresholds: ALT/AST ≤3x ULN (≤4x if MF-related), bilirubin ≤1.5x ULN (≤2x if MF-related/Gilbert's), creatinine ≤2.0 mg/dL.
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| Administration Dosage |
intravenous in dose cohorts of 70mg/m2 or 180 mg/m2
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| Related Clinical Trial | |||||
| NCT Number | NCT03895112 | Clinical Status | PHASE1 | ||
| Clinical Description | Phase I Study of AVID200 in Patients With Myelofibrosis (Myeloproliferative Neoplasms Research Consortium [MPN-RC] 118) | ||||
| Primary Endpoint |
Phase 1 evaluates the MTD of AVID200 over 6 cycles (21 days each) using a 3+3 design (max 12 patients, target toxicity rate 30%); subjects achieving clinical improvement (per IWG/ELN) or ≥1-grade bone marrow fibrosis reduction may continue in the extension phase.
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| Other Endpoint |
Efficacy assessments include IWG/ELN response criteria (CR, PR, clinical improvement, etc.) at Cycles 6/12, bone marrow fibrosis grade (MF-0 to MF-3), symptom burden (MFSAFv4.0; 0-100 scale), and quality of life (EORTC QLQ-C30; higher scores indicate poorer health), all evaluated up to Cycle 13.
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT03895112 | Clinical Status | Phase 1 | ||
| Clinical Description | Phase 1 study of AVID200 in patients with myelofibrosis (myeloproliferative neoplasms research consortium [MPN-RC] 118). | ||||
| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04914117 | Clinical Status | Phase 1 | ||
| Clinical Description | Phase 1, first-in-human, multicentre, open-label study of RC118 for injection in patients with locally advanced unresectable/metastatic solid tumours. | ||||
| Experiment 7 Reporting the Activity Date of This ADC | [7] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05205850 | Clinical Status | Phase 1 | ||
| Clinical Description | An open, multi-center phase 1/2a clinical study of RC118 for injection in patients with locally advanced unresectable or metastatic malignant solid tumors with positive expression of CLAUDIN 18.2. | ||||
References