Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0YANSF
ADC Name
BL-B01D1
Synonyms
BL B01D1; BLB01D1
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Organization
Sichuan Baili Pharmaceutical Co., Ltd.; Systimmune, Inc.; Chengdu Bailidote Biological Pharmaceutical Co., Ltd.
Drug Status
Phase 2
Indication
In total 9 Indication(s)
Breast cancer [ICD11:2C60-2C65]
Phase 2
EGFR(+) non-small cell lung cancer [ICD11:2C25]
Phase 2
Solid tumors [ICD11:2A00-2A0Z|2B50-2F9Z]
Phase 2
Epithelial tumor [ICD11:XH63D2]
Phase 1
Esophageal cancer [ICD11:2B70]
Phase 1
Head and neck squamous carcinoma [ICD11:2C31]
Phase 1
Lung cancer [ICD11:2C25]
Phase 1
Squamous cell cancer [ICD11:2D60-2D61]
Phase 1
Urothelial cancer [ICD11:2C9Z]
Phase 1
Drug-to-Antibody Ratio
8
Structure
Antibody Name
SI-B001
  Antibody Info 
Antigen Name
Receptor tyrosine-protein kinase erbB-3 (ERBB3); Epidermal growth factor receptor (EGFR)
  Antigen Info 
Payload Name
Camptothecin analogue ED04
  Payload Info 
Therapeutic Target
DNA topoisomerase 1 (TOP1)
  Target Info 
Linker Name
Mc-Gly-Gly-Phe-Gly
  Linker Info 
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 5 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT05194982
Phase 1
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.
Undisclosed  NCT05785039
Phase 2
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.

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Undisclosed  NCT05470348
Phase 1
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.

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Undisclosed  NCT05393427
Phase 1
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.

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Undisclosed  NCT05262491
Phase 1
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.

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Full List of Activity Data of This Antibody-drug Conjugate
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

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