Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0XMYPL
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| ADC Name |
DB-1311
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| Synonyms |
DB-1311; BNT324
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| Organization |
Duality Biotherapeutics (DualityBio) (Originator);BioNTech
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
6
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| Structure |
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| Antibody Name |
Anti-B7H3 antibody
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Antibody Info | ||||
| Antigen Name |
CD276 antigen (CD276); Hepatocyte growth factor receptor (MET)
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Antigen Info | ||||
| Payload Name |
P1021
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Mc-Gly-Gly-Phe-Gly
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
drozuntecan
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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 | ||||
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| Cervical cancer |
1 Trials
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| Head and neck cancer |
1 Trials
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| Liver cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Melanoma |
1 Trials
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| Oesophageal cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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| Prostate cancer |
1 Trials
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1 Trials
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| Unspecific solid tumor |
1 Trials
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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] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
28.6
45.5 % |
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| Patients Enrolled |
Eligible adults (≥18) have advanced solid tumors (measurable per RECIST 1.1/RANO 2.0), ECOG 0-1, LVEF ≥50%, and adequate organ function. Exclusions: prior B7-H3/TOP1-ADC therapy, uncontrolled cardiac/pulmonary conditions (e.g., CHF, ILD), active infections (HBV/HCV exceptions), untreated CNS metastases, or unresolved Grade ≥2 toxicity. Contraception is mandatory (7 months for females, 4 for males). Cohort-specific criteria apply (e.g., SCLC: prior platinum therapy; CRPC: progression per PCWG3).
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05914116 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/Metastatic Solid Tumors | ||||
| Primary Endpoint |
The Phase 1 study assesses DLTs (first 21 days), MTD/RP2D determination (over 12 months), and safety profile (TEAEs/SAEs per CTCAE v5.0 over ~1 year). Phase 2a evaluates ORR by RECIST 1.1 (non-CRPC/non-GBM), PCWG3 (CRPC bone metastases), or RANO 2.0 (GBM), alongside continued safety monitoring.
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| Other Endpoint |
Key secondary endpoints include ORR, DOR, DCR, TTR, PFS, OS (tracked for ~1 year), and PSA dynamics in CRPC. PK parameters (AUC, Cmax, Tmax, Ctrough) are analyzed over 8 cycles (21 days/cycle), alongside ADA prevalence/incidence. Tumor response criteria vary by cohort (RECIST 1.1, PCWG3, RANO 2.0).
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