Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0TKHGV
|
|||||
|---|---|---|---|---|---|---|
| ADC Name |
BG-C9074
|
|||||
| Synonyms |
BG-C9074; DB-1312; DB1312; BC-C9074
Click to Show/Hide
|
|||||
| Organization |
Duality Biotherapeutics (DualityBio) (Originator) (No Rights);BeiGene
|
|||||
| Drug Status |
Phase 1
|
|||||
| Drug-to-Antibody Ratio |
6
|
|||||
| Antibody Name |
Anti-B7H4 antibody
|
Antibody Info | ||||
| Antigen Name |
V-set domain-containing T-cell activation inhibitor 1 (VTCN1)
|
Antigen Info | ||||
| Payload Name |
TOP1 inhibitor
|
Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
|
Target Info | ||||
| Linker Name |
A cleavable linker
|
Linker Info | ||||
| Conjugate Type |
Random Cysteines
|
|||||
The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
|---|---|---|---|---|---|---|---|---|---|
| Biliary tract cancer |
1 Trials
|
||||||||
| Breast cancer |
1 Trials
|
||||||||
| Endometrial cancer |
1 Trials
|
||||||||
| Lung cancer |
1 Trials
|
||||||||
| Ovarian cancer |
1 Trials
|
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible participants (ECOG ≤1) have advanced solid tumors (measurable per RECIST v1.1), adequate organ function, and archived tumor tissue. Exclusions: prior B7H4-ADC/TOP1i-ADC therapy, active CNS metastases (<2cm/stable ≥4 weeks allowed), concurrent malignancies, ≥Grade 2 pneumonitis, uncontrolled infections, or diabetes. Contraception is required during and post-treatment (7 months for females, 4 months for males).
Click to Show/Hide
|
||||
| Administration Dosage |
.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT06233942 | Clinical Status | PHASE1 | ||
| Clinical Description | Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors | ||||
| Primary Endpoint |
Phase 1a evaluates safety (AE/SAE incidence), determines MTD/MAD of BG-C9074 (±tislelizumab), and establishes RDFE based on toxicity, PK/PD, and antitumor activity. Phase 1b assesses ORR by RECIST v1.1 and RP2D selection, with both phases spanning ~3 years of follow-up.
|
||||
| Other Endpoint |
Secondary endpoints include ORR, DOR, DCR, CBR (confirmed CR/PR/SD ≥24 weeks), and PFS per RECIST v1.1. PK parameters (Cmax, Cmin, Tmax, t½, AUC, CL/F, Vz/F, accumulation) and immunogenicity (ADA) are analyzed over ~3 years, with intensive sampling in the first 4 months.
|
||||
References