Antibody Information
General Information of This Antibody (ID: ANTI0APGVB)
| Antibody Name | Anti-EGFR/HER3 bsAb |
|||||
|---|---|---|---|---|---|---|
| Antigen Name | EGFR; HER3 |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
BL-B16D1 [Phase 1]
Identified from the Human Clinical Data
| 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.
|
||||
DB-1418 [Phase 1/2]
Discovered Using Cell Line-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Tumor Growth lnhibition value (TGl) |
83%
|
|||
| Method Description |
In the EGFR-dominant CAL-27 model, DB-1418 demonstrated a significant tumor growth inhibition (TGI) of 83% at a dose of 1.9 mg/kg Q3W
|
||||
| In Vivo Model | EGFR-dominant CAL-27 model | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Tumor Growth lnhibition value (TGl) |
98%
|
|||
| Method Description |
Notably, in an osimertinib-resistant NSCLC xenograft model with the C797S mutation, DB-1418 induced tumor regression with a TGI of 98% at a dose of 6 mg/kg Q3W.
|
||||
| In Vivo Model | Osimertinib-resistant NSCLC xenograft model with the C797S mutation | ||||
References