General Information of This Antibody
Antibody ID
ANI0WIOGY
Antibody Name
SI-B001
Organization
Sichuan Biokin Pharmaceutical Co., Ltd.
Indication
Hodgkin lymphoma; Nasopharyngeal Carcinoma
Antibody Type
Bispecific antibody (BsAb)
Antibody Subtype
Chimeric IgG1-kappa-(scFv-heavy-lambda)
Antigen Name
Receptor tyrosine-protein kinase erbB-3 (ERBB3); Epidermal growth factor receptor (EGFR)
 Antigen Info 
ChEMBI ID
CHEMBL4594484
Click to Show/Hide the Sequence Information of This Antibody
Heavy Chain Sequence
QVQLKQSGPGLVQPSQSLSITCTVSGFSLTNYGVHWVRQSPGKGLEWLGVIWSGGNTDYN
TPFTSRLSINKDNSKSQVFFKMNSLQSNDTAIYYCARALTYYDYEFAYWGQGTLVTVSSA
STKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG
LYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGP
SVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNS
TYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDEL
TKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQ
QGNVFSCSVMHEALHNHYTQKSLSLSPGGGGGSGGGGSQVQLQESGGGLVKPGGSLRLSC
AASGFTFSSYWMSWVRQAPGKGLEWVANINRDGSASYYVDSVKGRFTISRDDAKNSLYLQ
MNSLRAEDTAVYYCARDRGVGYFDLWGRGTLVTVSSGGGGSGGGGSGGGGSQSALTQPAS
VSGSPGQSITISCTGTSSDVGGYNFVSWYQQHPGKAPKLMIYDVSDRPSGVSDRFSGSKS
GNTASLIISGLQADDEADYYCSSYGSSSTHVIFGGGTKVTVL
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Heavy Chain Varible Domain
QVQLQESGPGLVKPSETLSITCTVSGFSLSNYDISWIRQPPGKGLEWLGVIWTGGATNYN
PALKSRLTISRDNSKNQVSLKMSSVTAADTAVYYCVRDSNYRYDEPFTYWGQGTLVTVSS
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Heavy Chain Constant Domain 1
ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS
GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKV
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Heavy Chain Constant Domain 2
APEAAGAPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTK
PREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAK
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Heavy Chain Constant Domain 3
GQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDS
DGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
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Heavy Chain Hinge Region
EPKSCDKTHTCPPCP
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Heavy Chain CDR 1
GFSLSNYD
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Heavy Chain CDR 2
IWTGGAT
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Heavy Chain CDR 3
VRDSNYRYDEPFTY
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Light Chain Sequence
DILLTQSPVILSVSPGERVSFSCRASQSIGTNIHWYQQRTNGSPRLLIKYASESISGIPS
RFSGSGSGTDFTLSINSVESEDIADYYCQQNNNWPTTFGAGTKLELKRTVAAPSVFIFPP
SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT
LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Light Chain Varible Domain
EIVLTQSPDTLSVTPKEKVTLTCRASQSIGTNIHWFQQKPGQSPKLLIKYASESISGVPS
RFSGSGSGTDFTLTINSVEAEDAATYYCQQSNSWPYTFGQGTKLEIK
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Light Chain Constant Domain
RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD
SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Light Chain CDR 1
QSIGTN
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Light Chain CDR 2
YAS
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Light Chain CDR 3
QQSNSWPYT
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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
BL-B01D1 [Phase 3]
Identified from the Human Clinical Data
Click To Hide/Show 5 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
61.80% (NSCLC EGFR mutation)
40.50% (NSCLC EGFR wildtype)
14.30% (SCLC)
45.80% (NPC)
7.70% (HNSCC)
Patients Enrolled
Patients with locally advanced or metastatic solid tumors.
Administration Dosage
BL-B01D1 was administered intravenously at doses of 2.50, 3.00 mg/kg D1D8 Q3W and 4.50, 5.00, 6.00 mg/kg D1 Q3W.
Related Clinical Trial
NCT Number NCT05194982  Clinical Status Phase 1
Clinical Description
A phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-B01D1 in patients with locally advanced or metastatic solid tumor.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT05785039  Clinical Status Phase 2
Clinical Description
Phase 2a/2b clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors such as locally advanced or metastatic urinary system tumors.
Experiment 3 Reporting the Activity Date of This ADC [3]
Related Clinical Trial
NCT Number NCT05470348  Clinical Status Phase 1
Clinical Description
A phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-B01D1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumors.
Experiment 4 Reporting the Activity Date of This ADC [4]
Related Clinical Trial
NCT Number NCT05393427  Clinical Status Phase 1
Clinical Description
A phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-B01D1 in patients with locally advanced or metastatic urological tumors and other solid tumors.
Experiment 5 Reporting the Activity Date of This ADC [5]
Related Clinical Trial
NCT Number NCT05262491  Clinical Status Phase 1
Clinical Description
A phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor.
References
Ref 1 BL-B01D1, a first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic solid tumor: Results from a first-in-human phase 1 study. J Clin Oncol. 2023 41:16_suppl, 3001-3001.
Ref 2 Phase IIa/IIb Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors Such as Locally Advanced or Metastatic Urinary System Tumors, NCT05785039
Ref 3 A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors, NCT05470348
Ref 4 A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors, NCT05393427
Ref 5 A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor, NCT05262491