Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0FOOJX
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| ADC Name |
ABL202
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| Synonyms |
ABL202; LCB71; CS5001
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| Organization |
LCB (Originator);CStone Pharmaceuticals;ABL Bio
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
2
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| Structure |
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| Antibody Name |
Anti-ROR1 IgG1 mAb
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Antibody Info | ||||
| Antigen Name |
Inactive tyrosine-protein kinase transmembrane receptor ROR1 (ROR1)
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Antigen Info | ||||
| Payload Name |
PBD dimer
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Payload Info | ||||
| Therapeutic Target |
Human deoxyribonucleic acid (hDNA)
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Target Info | ||||
| Linker Name |
β-glucuronide trigger linker
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Linker Info | ||||
| Conjugate Type |
Enzymatic Catalysis
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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 hematological malignancies |
1 Trials
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| Unspecific solid tumor |
1 Trials
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ADC-specific functional property(2027 Update)
Binding Affinity
| Dissocation Constant (Kd) | Binding Target | Description | Reference |
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| 1.38 nM |
ROR1
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CS5001 bound to human ROR1, but not ROR2, with a KD value of 1.38 nM.
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[1]
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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 | [2] | ||||
| Patients Enrolled |
Inclusion criteria for dose escalation: solid tumor patients (≥1 prior systemic therapy) or lymphoma patients (≥2 prior therapies per 2016 WHO criteria) with ≥1 evaluable lesion (RECIST v1.1/Lugano 2014). Dose expansion includes MCL, DLBCL (both post-≥2 therapies including BTK inhibitors), and TNBC (post-≥2 therapies), all requiring measurable lesions. Additional requirements: life expectancy >3 months, ECOG 0/1, adequate organ function, tumor tissue/blood sample provision, negative pregnancy test (females), and contraception use by all participants.
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| Administration Dosage |
CS5001 will be administered every 3 weeks (21 days) by intravenous (IV) infusion, and 3 weeks (21 days) is considered as one treatment cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT05279300 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS5001, an Anti-ROR1 Antibody Drug Conjugate, in Patients With Advanced Solid Tumors and Lymphomas | ||||
| Primary Endpoint |
The study will determine the Maximum Tolerated Dose (MTD) of CS5001 during dose escalation (over ~6 months) based on dose-limiting toxicities (DLTs) observed in participants receiving triweekly injections. The Recommended Phase 2 Dose (RP2D) will be derived from MTD data or a lower tolerable dose, incorporating safety, pharmacokinetic, pharmacodynamic, and efficacy profiles. Adverse events will be monitored for severity and incidence until 90 days post-treatment or new anticancer therapy initiation.
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| Other Endpoint |
Pharmacokinetic analysis will measure concentrations of CS5001 total antibody, prodrug, free cytotoxin, and anti-CS5001 antibodies, with sampling up to 30 days after the last dose or until new anticancer therapy begins.
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References