Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0EWQKX
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| ADC Name |
Ozuriftamab vedotin
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| Synonyms |
ozuriftamab vedotin; BA3021; CAB-ROR2-ADC; HTBA3021; Oz-V
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| Organization |
BioAtla (Originator);Curexsys Biotech
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| Drug Status |
Phase 2
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Ozuriftamab
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Antibody Info | ||||
| Antigen Name |
Inactive tyrosine-protein kinase transmembrane receptor ROR1 (ROR1); Tyrosine-protein kinase transmembrane receptor ROR2 (ROR2)
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Antigen Info | ||||
| Payload Name |
MMAE
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Payload Info | ||||
| Therapeutic 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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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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Breast cancer |
1 Trials
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| Head and neck cancer |
1 Trials
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1 Trials
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| Lung cancer |
1 Trials
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| Melanoma |
1 Trials
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General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Maximum Observed Concentration (Cmax) | 14 | ug/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 1 mg/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 440 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 1 mg/kg, AUCinf.
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[1] |
| Maximum Observed Concentration (Cmax) | 48 | ug/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 3 mg/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1500 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 3 mg/kg, AUCinf.
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[1] |
| Maximum Observed Concentration (Cmax) | 208 | ug/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 10 mg/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 8210 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 10 mg/kg, AUCinf.
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[1] |
| Maximum Observed Concentration (Cmax) | 24 | ug/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 1 .
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[1] |
| Maximum Observed Concentration (Cmax) | 24 | ug/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 22 .
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 580 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 637 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 22, AUCinf.
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[1] |
| Maximum Observed Concentration (Cmax) | 67 | ug/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 1 .
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[1] |
| Maximum Observed Concentration (Cmax) | 67 | ug/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 22 .
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1870 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2130 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 22, AUCinf.
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[1] |
| Maximum Observed Concentration (Cmax) | 139 | ug/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 1 .
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[1] |
| Maximum Observed Concentration (Cmax) | 124 | ug/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 22 .
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4450 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4310 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 22, AUCinf.
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[1] |
Distribution
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 440 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 1 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1500 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 3 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 8210 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 10 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 580 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 637 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 22, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1870 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2130 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 22, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4450 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4310 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 22, AUCinf.
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[1] |
Metabolism
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 440 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 1 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1500 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 3 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 8210 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 10 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 580 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 637 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 22, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1870 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2130 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 22, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4450 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4310 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 22, AUCinf.
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Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 440 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 1 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1500 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 3 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 8210 | ug*h/mL |
Summary of PK parameters for BA3021 in cynomolgus monkeys, 10 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 580 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 637 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 22, AUCinf.
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| Elimination Half-Life (t1/2) | 55 | h |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 1 .
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[1] |
| Elimination Half-Life (t1/2) | 39 | h |
The cynomolgus monkeys were given BA3021 via intravenous injection at 1 mg/kg on Day 22 .
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1870 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2130 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 22, AUCinf.
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[1] |
| Elimination Half-Life (t1/2) | 61 | h |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 1 .
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[1] |
| Elimination Half-Life (t1/2) | 49 | h |
The cynomolgus monkeys were given BA3021 via intravenous injection at 3 mg/kg on Day 22 .
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4450 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 1, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4310 | ug*h/mL |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 22, AUCinf.
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[1] |
| Elimination Half-Life (t1/2) | 68 | h |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 1 .
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[1] |
| Elimination Half-Life (t1/2) | 71 | h |
The cynomolgus monkeys were given BA3021 via intravenous injection at 6 mg/kg on Day 22 .
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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 | Objective Response Rate (ORR) |
32%
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| Patients Enrolled |
Eligibility covers stage III-IV SCCHN (oropharynx/larynx, excluding nasopharynx) in neoadjuvant/recurrent/metastatic settings; requires ECOG 0-1, measurable disease, and adequate organ function. Exclusions: prior PD-1/L1/CTLA-4 therapy (unless second-line), Grade≥3 mAb allergies, active HIV/HBV/HCV, or pregnancy.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05271604 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | ||||
| Primary Endpoint |
The efficacy endpoint includes confirmed ORR per RECIST v1.1 over 24 months, alongside AE/SAE incidence graded by CTCAE v5.
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| Other Endpoint |
Additional efficacy measures assess DOR, PFS, BOR, DCR (CR/PR/SD≥12w), TTR, OS, and CR rate-all evaluated for up to 24 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients have advanced/metastatic solid tumors (NSCLC/TNBC/STS preferred) refractory to SOC, measurable disease, ECOG 0-1, and adequate organ function; exclusions include active CNS metastases, prior auristatin therapy, Grade≥3 mAb allergies, HIV/HBV/HCV, or pregnancy within 4 weeks of surgery.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT03504488 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1/2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-ROR2-ADC, Alone and in Combination With a PD-1 Inhibitor, in Patients With Advanced Solid Tumors (Ph1) and Melanoma and NSCLC Patients (Ph2) | ||||
| Primary Endpoint |
Phase 1 assesses DLTs, MTD, and AE/SAE frequency/severity over 24 months; Phase 2 evaluates confirmed ORR (CR/PR rate).
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| Other Endpoint |
Phase 1 tracks PK profiles (ADC/MMAE plasma levels, Cmax, AUC), immunogenicity (ADA development), and efficacy (ORR, DOR, PFS, BOR, DCR, TTR, OS, tumor size change) across 24 months; Phase 2 expands efficacy endpoints.
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| Experiment 3 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible participants are women aged ≥18 with platinum-resistant high-grade serous ovarian, fallopian tube, or peritoneal cancer, confirmed histologically, with measurable disease per RECIST 1.1, amenable to biopsies, and adequate organ function. Exclusion criteria include uncontrolled comorbidities, prior malignancies affecting safety assessment, active infections, severe autoimmune disorders, CNS metastases requiring steroids, pregnancy, and recent live vaccines.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT04918186 | Clinical Status | PHASE2 | ||
| Clinical Description | An Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer | ||||
| Primary Endpoint |
The primary objective is to assess the objective response rate (ORR) by investigator evaluation using RECIST 1.1 criteria over 36 months, aiming to identify effective immunotherapy combinations for high-grade serous ovarian cancer for future randomized trials.
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| Other Endpoint |
Key secondary endpoints include evaluating ORR via RECIST 1.1, progression-free survival (PFS) and overall survival (OS) by RECIST 1.1 and iRECIST, as well as monitoring adverse event frequency and severity over 36 months.
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References