Antibody Information
General Information of This Antibody
| Antibody ID | ANI0TIQFA |
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| Antibody Name | BMS-986021 |
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| Synonyms |
Anti-MSLN mAb 6A4; Fully human IgG1 anti-MSLN mAb 6A4
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| Antibody Type | Monoclonal antibody (mAb) |
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| Antibody Subtype | Humanized IgG1-kappa |
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| Antigen Name | Mesothelin (MSLN) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
| Heavy Chain Sequence |
EVHLVESGGGLVQPGGSLRLSCAASGFTFSRYWMSWVRQAQGKGLEWVASIKQAGSEKTY
VDSVKGRFTISRDNAKNSLSLQMNSLRAEDTAVYYCAREGAYYYDSASYYPYYYYYSMDV WGQGTTVTVSS Click to Show/Hide
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| Light Chain Sequence |
EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLIYGASSRATGIP
DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSSQYTFGQGTKLEIK 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
BMS-986148 [Phase 1/2 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
2.00
6.00 4.00 9.00 20.00 23.00 % |
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| Patients Enrolled |
Pleural or peritoneal mesothelioma (except sarcomatoid mesothelioma), ovarian cancer (except mucinous carcinoma), pancreatic cancer, gastric cancer, or non-small cell lung cancer (adenocarcinoma only).
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| Administration Dosage |
BMS-986148 monotherapy (0.1-1.6 mg/kg intravenously (i.v.) every 3 weeks or 0.4 or 0.6 mg/kg i.v. once weekly; n = 96) or BMS-986148 0.8 mg/kg + nivolumab 360 mg i.v. every 3 weeks (n = 30). The primary endpoint was safety and tolerability.
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| Related Clinical Trial | |||||
| NCT Number | NCT02341625 | Clinical Status | Phase 1/2a | ||
| Clinical Description |
A phase 1/2a study of BMS-986148, a mesothelin directed antibody drug conjugate, in subjects with select advanced solid tumors.
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| Primary Endpoint |
The MTD and the recommended dose for the part 2 monotherapy expansion is BMS-986148 1.20 mg/kg every 3 weeks dose level. The MTD in the combination expansion cohort is BMS-986148 0.80 mg/kg + nivolumab 360 mg every 3 weeks.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02341625 | Clinical Status | Phase 1/2 | ||
| Clinical Description |
A phase 1/2a study of BMS-986148, a mesothelin directed antibody drug conjugate, in subjects with select advanced solid tumors.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
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| NCT Number | NCT02884726 | Clinical Status | Phase 1 | ||
| Clinical Description |
A phase 1 study of the safety and tolerability of BMS 986148 in subjects with advanced and/or metastatic solid tumors.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
9%
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| Patients Enrolled |
Eligible participants (≥18 years, ECOG 0-1) must have mesothelin-positive measurable tumors (pancreatic/ovarian/gastric/NSCLC/mesothelioma) and ≥3-month life expectancy. Exclusions cover brain metastases, active/hepatitis infections, major surgery (<1 month), uncontrolled cardiac/liver/bone marrow dysfunction, or hypersensitivity to mesothelin antibodies/tubulysin/nivolumab-related agents.
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| Related Clinical Trial | |||||
| NCT Number | NCT02341625 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors
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| Primary Endpoint |
Safety outcomes include adverse events (AEs, SAEs, discontinuations, deaths) and laboratory toxicity shifts (hematology/chemistry) from baseline to 100 days post-treatment (≤6 months), analyzed by NCT CTCAE v4.03 criteria and grouped by dose/regimen.
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| Other Endpoint |
Pharmacokinetics (Cmax, Tmax, Ctau, Ctrough, AUC (0-t), AUC[TAU]) are assessed during Cycle 1, with arithmetic %CV reported. Efficacy endpoints (up to 58 months) include best overall response (CR/PR/SD/PD), ORR, duration of response (DoR), progression-free survival (PFS), and PFS rates (4-12 months), stratified by tumor type (mesothelioma, pancreatic, ovarian, NSCLC, gastric). QTcF interval changes and ADA status are also evaluated by dose/regimen.
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible participants must have advanced/metastatic mesothelin-expressing solid tumors, progression/intolerance to standard therapy, measurable disease per RECIST, and ECOG 0-1. Exclusions include brain metastases, uncontrolled cardiovascular disease, eye/peripheral neuropathy, hepatitis B/C infection, or other protocol-specified conditions.
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| Administration Dosage |
Specified dose on specified days
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| Related Clinical Trial | |||||
| NCT Number | NCT02884726 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1 Study of the Safety and Tolerability of BMS 986148 in Subjects With Advanced and/or Metastatic Solid Tumors
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| Primary Endpoint |
Safety analysis covers adverse events (AEs/SAEs), including discontinuations and deaths, from Day 1 to 30 days post-treatment, with grading and laboratory toxicity shifts from baseline as key metrics for participant safety assessment.
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| Other Endpoint |
Pharmacokinetic parameters (Cmax, Tmax, AUC (0-T), AUC (TAU), Ctrough, etc.) and accumulation indices (AI) are evaluated from Day 1 to 84, alongside tumor response based on RECIST criteria post-BMS-986148 treatment to assess drug exposure and efficacy.
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References