Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0RJKWE
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| ADC Name |
Bezetabart debotansine
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| Synonyms |
bezetabart debotansine; STRO-001; BN301
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| Organization |
Sutro Biopharma (Originator);Yehui Medicine
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| Drug Status |
Phase 1/2 (discontinued)
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| Drug-to-Antibody Ratio |
2
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| Structure |
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| Antibody Name |
Bezetabart
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Antibody Info | ||||
| Antigen Name |
HLA class II histocompatibility antigen gamma chain (CD74)
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Antigen Info | ||||
| Payload Name |
SC347
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Cys-12 ADC linker
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Linker Info | ||||
| Conjugate Type |
Non-natural Amino Acids
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| Combination Type |
debotansine
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| Special Approval(s) |
Orphan drug (FDA)
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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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| Diffuse large b-cell lymphoma |
1 Trials
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1 Trials
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| Follicular lymphoma |
1 Trials
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1 Trials
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| Mantle cell lymphoma |
1 Trials
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1 Trials
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| Multiple myeloma |
1 Trials
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| Unspecific non-hodgkin lymphoma |
1 Trials
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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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| 1.1 nM |
Human CD74
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Conjugation to the non-cleavable linker-maytansine warhead did not affect the binding affinity of SP7219 since STRO-001 retained high binding affinity to CHO cells expressing human (KD = 1.1 nM) and monkey CD74 (KD = 1.0 nM)
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[1]
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| 1 nM |
Monkey CD74
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Conjugation to the non-cleavable linker-maytansine warhead did not affect the binding affinity of SP7219 since STRO-001 retained high binding affinity to CHO cells expressing human (KD = 1.1 nM) and monkey CD74 (KD = 1.0 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] | ||||
| 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 | ||||
| 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 | [3] | ||||
| 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 | ||||
| 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