Antibody Information
General Information of This Antibody
| Antibody ID | ANI0QJELP |
|||||
|---|---|---|---|---|---|---|
| Antibody Name | Bivatuzumab |
|||||
| Organization | C.H. Boehringer Sohn AG & Co. KG; Boehringer Ingelheim GmbH |
|||||
| Indication | Adenocarcinoma |
|||||
| Synonyms |
BIWA 4; BIWA4; BIWA-4
Click to Show/Hide
|
|||||
| Antibody Type | Monoclonal antibody (mAb) |
|||||
| Antibody Subtype | Humanized IgG1-kappa |
|||||
| Antigen Name | CD44 antigen (CD44) |
Antigen Info | ||||
| ChEMBI ID | ||||||
| DrugBank ID | ||||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
| Heavy Chain Sequence |
EVQLVESGGGLVKPGGSLRLSCAASGFTFSSYDMSWVRQAPGKGLEWVSTISSGGSYTYY
LDSIKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARQGLDYWGRGTLVTVSSASTKGP SVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLF PPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVV SVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQV SLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVF SCSVMHEALHNHYTQKSLSLSPGK Click to Show/Hide
|
|||||
| Light Chain Sequence |
EIVLTQSPATLSLSPGERATLSCSASSSINYIYWYQQKPGQAPRLLIYLTSNLASGVPAR
FSGSGSGTDFTLTISSLEPEDFAVYYCLQWSSNPLTFGGGTKVEIKRTVAAPSVFIFPPS DEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTL SKADYEKHKVYACEVTHQGSSPVTKSFNRGEC Click to Show/Hide
|
|||||
Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Bivatuzumab mertansine [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients (18-80 years) must have histologically confirmed recurrent/metastatic head/neck or esophageal squamous cell carcinoma refractory to standard treatments, measurable disease, ECOG ≤2, and life expectancy ≥3 months. Key exclusions include antibody hypersensitivity, active infections, untreated brain metastases, grade ≥2 neuropathy, significant hematologic/hepatic/renal dysfunction (ANC <1500/mm <sup>3</sup>, platelets <100K/mm <sup>3</sup>, bilirubin >1.5mg/dl, AST/ALT >3×ULN, creatinine >1.5mg/dl), recent anticancer therapy (<4 weeks), pregnancy, or protocol non-compliance.
Click to Show/Hide
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT02254044 | Clinical Status | PHASE1 | ||
| Clinical Description |
An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus With Repeated Administration Courses in Patients With Clinical Benefit
|
||||
| Primary Endpoint |
The primary objective is to determine the maximum tolerated dose (MTD) of the investigational drug within a 6-month observation period.
|
||||
| Other Endpoint |
Safety evaluations include monitoring adverse events (graded by CTC criteria), clinically significant lab/vital sign abnormalities, and HAHA development for 14 days post-treatment. Pharmacokinetic parameters (AUC0-168, AUC0-tz, AUC0-∞, Cmax, tmax, t1/2, MRT, CL, Vss, Vz, Cpre,ss, Cmin,ss, LI, RA) are assessed for 14 days post-dosing. Tumor response is evaluated per RECIST criteria.
Click to Show/Hide
|
||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients are women ≥18 years with CD44v6+ (≥50% tumor cells) metastatic breast cancer refractory to anthracyclines/taxanes, measurable lesions (MRI/CT), ECOG ≤2, and life expectancy ≥6 months. Exclusions include antibody hypersensitivity, active infections, untreated brain metastases, grade ≥2 neuropathy, hematologic/organ dysfunction (ANC <1500/mm <sup>3</sup>, platelets <100K/mm <sup>3</sup>, bilirubin >1.5mg/dl, AST/ALT >3×ULN, creatinine >1.5mg/dl), recent anticancer therapy (<4 weeks), pregnancy, or protocol non-compliance.
Click to Show/Hide
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT02254005 | Clinical Status | PHASE1 | ||
| Clinical Description |
An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Female Patients With CD44v6 Positive Metastatic Breast Cancer With Repeated Administration in Patients With Clinical Benefit
|
||||
| Primary Endpoint |
The study aims to determine the maximum tolerated dose (MTD) of bivatuzumab mertansine within a 21-day evaluation period.
|
||||
| Other Endpoint |
Safety assessments (AEs, lab abnormalities, vital signs) and pharmacokinetic markers (drug concentration, anti-CD44v6-IgG, HAHA development) are monitored for 21 days. Tumor response is evaluated per RECIST criteria over 1 year.
|
||||
| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients are women ≥18 years with CD44v6+ (≥50% tumor cells) locally recurrent/metastatic breast cancer refractory to anthracyclines/taxanes, having measurable lesions (MRI/CT), ECOG ≤2, and ≥6 months life expectancy. Key exclusions include antibody hypersensitivity, active infections, untreated brain metastases, grade ≥2 neuropathy, significant hematologic/organ dysfunction, recent anticancer therapies (<4 weeks), pregnancy/lactation, or protocol non-compliance.
Click to Show/Hide
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT02254031 | Clinical Status | PHASE1 | ||
| Clinical Description |
An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer With Repeated Administration Courses in Patients With Clinical Benefit
|
||||
| Primary Endpoint |
The primary objective is to determine the maximum tolerated dose (MTD) of the study drug, with evaluation up to 6 months from treatment initiation.
|
||||
| Other Endpoint |
Secondary outcomes include safety assessments (adverse events graded by CTC criteria, lab abnormalities, vital signs, and HAHA development) and comprehensive pharmacokinetic parameters (AUC, Cmax, tmax, clearance rates, volume of distribution) measured within 14 days post-treatment. Tumor response will be evaluated per RECIST criteria during this same timeframe.
Click to Show/Hide
|
||||
| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Enrollment criteria: Adults (≥18 years) with histologically confirmed, measurable recurrent/metastatic disease (MRI/CT), ECOG ≤2, ≥6-month life expectancy, and no active infections/brain metastases. Excluded: hypersensitivity to immunoconjugates, significant cytopenias/organ dysfunction, recent anticancer therapies (<3-4 weeks), pregnancy, or protocol non-adherence.
Click to Show/Hide
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT02254018 | Clinical Status | PHASE1 | ||
| Clinical Description |
An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck With Repeated Administration in Patients With Clinical Benefit
|
||||
| Primary Endpoint |
The primary endpoint is determining the maximum tolerated dose (MTD) of bivatuzumab mertansine within a 21-day evaluation period in patients with treatment-refractory head and neck squamous cell carcinoma.
|
||||
| Other Endpoint |
Secondary assessments include safety profiles (CTC-graded adverse events, lab/vital sign abnormalities, HAHA development) and efficacy (RECIST tumor response monitored for 1 year), along with pharmacokinetic measurements (drug and anti-CD44v6-IgG concentrations) during the 21-day treatment course.
|
||||
| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
0%
|
|||
| Patients Enrolled |
Metastatic breast cancer (MBC) that expresses CD44v6 in at least 50% of tumor cells in primary tumor tissue as assessed by immunohistochemistry, pretreatment with anthracyclines and taxanes, tumor metastases measurable by computed tomography (CT) or magnetic resonance imaging (MRI), life expectancy of at least 6 months, no chemotherapy, radiotherapy or immunotherapy within the last 4 weeks before study entry, adequate organ function, Eastern Cooperative Oncology Group performance score 2.
Click to Show/Hide
|
||||
| Administration Dosage |
One single intravenous infusion over 30 min, dose was escalated in 25 mg/m2 increments up to the maximum tolerated dose (MTD).
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT02254005 | Clinical Status | Phase 1 | ||
| Clinical Description |
An open phase 1 single dose escalation study of bivatuzumab mertansine administered intravenously in female patients with CD44v6 positive metastatic breast cancer with repeated administration in patients with clinical benefit.
|
||||
| Primary Endpoint |
The MTD in this trial could not be determined.
|
||||
| Other Endpoint |
No objective responses were observed. Disease stabilization was achieved in 50.00% of patients independently of dose level.
|
||||
| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Patients Enrolled |
Ecurrent or metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to established treatments, an ECOG score 2, and an estimated life expectancy of at least 6 months, a tumor diameter of at least 1 cm in CT or MRI scans was also required.
|
||||
| Administration Dosage |
Starting with 25 mg/m2, the dose was escalated in steps of 25 mg/m2 until dose limiting toxicity was observed, intravenously.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT02254044 | Clinical Status | Phase 1 | ||
| Clinical Description |
An open phase 1 dose escalation study of bivatuzumab mertansine administered intravenously once per week for three weeks in patients with advanced squamous cell carcinoma of the head and neck or esophagus with repeated administration courses in patients with clinical benefit.
|
||||
| Primary Endpoint |
The MTD was 300 mg/m2.
|
||||
| Other Endpoint |
Due to the premature discontinuation of the trial efficacy complying with the study plan could not be assessed. In 3 patients,a partial response at doses of 2.00, 2.75 and 3.25 mg/m2.
|
||||
| Experiment 7 Reporting the Activity Date of This ADC | [7] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02254044 | Clinical Status | Phase 1 | ||
| Clinical Description |
An open phase 1 dose escalation study of bivatuzumab mertansine administered intravenously once per week for three weeks in patients with advanced squamous cell carcinoma of the head and neck or esophagus with repeated administration courses in patients with clinical benefit.
|
||||
| Experiment 8 Reporting the Activity Date of This ADC | [8] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02254031 | Clinical Status | Phase 1 | ||
| Clinical Description |
An open phase 1 dose escalation study of bivatuzumab mertansine administered intravenously once per week for three weeks in female patients with CD44V6 positive recurrent or metastatic breast cancer with repeated administration courses in patients with clinical.
|
||||
| Experiment 9 Reporting the Activity Date of This ADC | [9] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02254005 | Clinical Status | Phase 1 | ||
| Clinical Description |
An open phase 1 single dose escalation study of bivatuzumab mertansine administered intravenously in female patients with CD44v6 positive metastatic breast cancer with repeated administration in patients with clinical benefit.
|
||||
| Experiment 10 Reporting the Activity Date of This ADC | [10] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02254018 | Clinical Status | Phase 1 | ||
| Clinical Description |
An open phase 1 single dose escalation study of bivatuzumab mertansine administered intravenously in patients with advanced squamous cell carcinoma of the head and neck with repeated administration in patients with clinical benefit.
|
||||
References