Antibody Information
General Information of This Antibody
| Antibody ID | ANI0QYT012 |
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| Antibody Name | Bezetabart |
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| Organization | Sutro Biopharma, Inc.; BioNova Pharmaceuticals (Shanghai) Ltd.; Piramal Pharma Solutions, Inc. |
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| Synonyms |
Bezetabart
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| Antibody Type | Monoclonal antibody (mAb) |
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| Antigen Name | HLA class II histocompatibility antigen gamma chain (CD74) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
| Heavy Chain Sequence |
QVQLVESGGGVVQPGRSLRLSCAASGFNFSDYGMHWVRQAPGKGLEWVAVIWYDGSISYY
ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARGGTVEHGAVYGTDVWGQGTTVT VSS Click to Show/Hide
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| Light Chain Sequence |
DIQMTQSPSSVSASVGDRVTITCRASQGIGSWLAWYQQKPGKAPKLLIYAADRLQSGVPS
RFSGSGSGTDFTLTISSLQPEDFATYYCQQYHTYPLTFGGGTKVEIK Click to Show/Hide
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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
Bezetabart debotansine [Phase 1/2 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
25%
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| Patients Enrolled |
Eligible patients (≥18 years) must have relapsed/refractory MM/NHL, ECOG 0-2, >3-month life expectancy, and adequate organ function. Exclusions include active CNS involvement, Grade≥2 neuropathy, uncontrolled infections (HBV/HCV/HIV), QTcF≥500ms, prior CD74-targeted therapy, or significant cardiac/pulmonary disease. 18 patients with NHL have been treated at 9 dose levels: .05, .075, .15, .27, .43, .65, .91, 1.27 and 1.78 mg/kg.
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| Administration Dosage |
Patients with advanced, relapsed/refractory NHL are eligible for enrollment. STRO-001 is administered as a 60-minute IV infusion. STRO-001 was initially administered on Days 1 and 15 of a 28-day cycle. Starting at 0.91 mg/kg, STRO-001 was administered on Day 1 of a 3-week cycle. Treatment is administered until disease progression or unacceptable toxicity.
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| Related Clinical Trial | |||||
| NCT Number | NCT03424603 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies
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| Primary Endpoint |
This study evaluates STRO-001's safety (AE incidence) and establishes MTD/RP2D during dose escalation (18 months), while assessing efficacy (ORR per IMWG/Lugano criteria) in MM/NHL expansion cohorts over 24 months.
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| Other Endpoint |
PK parameters (Cmax, t1/2, AUCinf, CL, Vss) and immunogenicity (ADA) are characterized in both phases. Expansion cohorts further analyze safety, DOR, PFS and PK over 24 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients (≥18 years) must have histologically confirmed B-cell NHL (DLBCL/FL/MZL/MCL) with ≥2 prior therapies (including anti-CD20 regimens), measurable lesions (≥1.5cm nodal/≥1.0cm extranodal), ECOG 0-2. Key exclusions: CNS lymphoma, active HBV/HCV/HIV, QTcF>450/470ms (M/F), CAR-T within 60 days, prior CD74-targeted therapy, or unresolved toxicity >Grade 1 (except alopecia).
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| Administration Dosage |
Will be administered by intravenous infusion every 3 weeks on D1
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| Related Clinical Trial | |||||
| NCT Number | NCT05611853 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN301,An Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-cell Non-Hodgkin's Lymphoma
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| Primary Endpoint |
The study evaluates safety (CTCAE v4.0.3) and efficacy (Lugano 2014 criteria ORR) of BN301 over 12-24 months in relapsed/refractory B-cell NHL patients.
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| Other Endpoint |
Pharmacokinetic parameters (Cmax, Tmax, t1/2, AUC0-t) and CD74 expression correlation with efficacy are analyzed over 12 months in plasma samples.
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References
