Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0QZUFE)
ADC Name
BL-B16D1
Synonyms
BL-B16D1
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Organization
Sichuan Biokin Pharmaceutical (Originator)
Drug Status
Phase 1
Antibody Name
Anti-EGFR/HER3 bsAb
  Antibody Info 
Antigen Name
Epidermal growth factor receptor (EGFR); Receptor tyrosine-protein kinase erbB-3 (HER3)
  Antigen Info 
Payload Name
WA-00
  Payload Info 
Payload Target
Microtubule (MT)
  Target Info 
Linker Name
Undisclosed
Conjugate Type
Undisclosed
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
Indication Phase 1 Phase 2 Phase 3 Approved
Unspecific solid tumor
4 Trials
Trial ID
NCT06493864; CTR20242403
NCT06469008; CTR20242224
NCT06475131; CTR20242283
ChiCTR2500109924
Breast cancer
1 Trials
Trial ID
NCT06493864; CTR20242403
Head and neck cancer
1 Trials
Trial ID
NCT06469008; CTR20242224
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT06469008
PHASE1
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

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Undisclosed  NCT06493864
PHASE1
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumor

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Undisclosed  NCT06475131
PHASE1
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-B16D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible patients (18-75 years) must have recurrent/metastatic solid tumors (HNSCC prioritized) with measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, archived/fresh tumor tissue, and resolved prior treatment toxicities (≤Grade 1), with reproductive safeguards (contraception for 6 months post-treatment).
Administration Dosage
Administration by intravenous infusion for a cycle of 3 weeks.
Related Clinical Trial
NCT Number NCT06469008  Clinical Status PHASE1
Clinical Description A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Primary Endpoint
Phase Ia assesses DLTs (NCI-CTCAE v5.0) and MTD within 21 days post-first dose, while Phase Ib determines RP2D (within 24 months) based on integrated safety, efficacy, PK, and PD data of BL-B16D1.
Other Endpoint
Key measures include TEAE monitoring, PK parameters (Cmax/Tmax/T1/2/AUC0-t/CL/Ctrough), ADA incidence, and efficacy outcomes (ORR/DCR/DOR per RECIST 1.1) over 24 months, evaluating both safety and antitumor activity of BL-B16D1.
Experiment 2 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Eligible patients (18-75) must have advanced/metastatic solid tumors (breast cancer prioritized) with measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, available tumor tissue, resolved prior toxicities (≤Grade 1), and use contraception for 6 months post-treatment.
Administration Dosage
Administration by intravenous infusion for a cycle of 3 weeks.
Related Clinical Trial
NCT Number NCT06493864  Clinical Status PHASE1
Clinical Description A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumor
Primary Endpoint
Phase Ia evaluates DLTs (NCI-CTCAE v5.0) and MTD within 21 days post-dose, while Phase Ib determines RP2D (24 months) based on integrated safety, efficacy, PK/PD data of BL-B16D1.
Other Endpoint
Key measures include TEAE monitoring, PK parameters (Cmax/Tmax/T1/2/AUC0-t/CL/Ctrough), ADA incidence, and efficacy outcomes (ORR/DCR/DOR per RECIST 1.1) over 24 months.
Experiment 3 Reporting the Activity Date of This ADC [3]
Patients Enrolled
Eligible patients (18-75) must have advanced/metastatic solid tumors with measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, available tumor tissue, resolved prior toxicities (≤Grade 1), and use contraception for 6 months post-treatment.
Administration Dosage
Administration by intravenous infusion for a cycle of 3 weeks.
Related Clinical Trial
NCT Number NCT06475131  Clinical Status PHASE1
Clinical Description A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-B16D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Primary Endpoint
Phase Ia evaluates DLTs (NCI-CTCAE v5.0) and determines MTD within 21 days post-dose, while Phase Ib establishes RP2D (24 months) based on comprehensive safety, efficacy, PK/PD data of BL-B16D1.
Other Endpoint
Key assessments include TEAE monitoring, PK parameters (Cmax/Tmax/T1/2/AUC0-t/CL/Ctrough), ADA incidence, and efficacy outcomes (ORR/DCR/DOR per RECIST 1.1) over 24 months of BL-B16D1 treatment.
References
Ref 1 A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Ref 2 A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Ref 3 A Study of BL-B16D1 in Patients With Locally Advanced or Metastatic Solid Tumors