Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0AKWMB |
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| Antibody Name | A human anti-ROR1 IgG1 mAb |
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| Synonyms |
A human anti-ROR1 IgG1 mAb
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| Antigen Name | Inactive tyrosine-protein kinase transmembrane receptor ROR1 (ROR1) |
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
ABL202 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| 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
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| 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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