Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0ENYRQ
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| ADC Name |
Trastuzumab pamirtecan
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| Synonyms |
trastuzumab pamirtecan; DB-1303; BNT323; T-Pam
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| Organization |
Duality Biotherapeutics (DualityBio) (Originator);3SBio;BioNTech
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| Drug Status |
New Drug Application
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
BAT-0606
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
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Antigen Info | ||||
| Payload Name |
P1003
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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 |
pamirtecan
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| Special Approval(s) |
Fast track (FDA)
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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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| Breast cancer |
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| Endometrial cancer |
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] | ||||
| Patients Enrolled |
Eligible participants are adults (≥18) with HR+, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer, disease progression after prior endocrine ± targeted therapy, measurable lesions per RECIST 1.1, ECOG PS 0-1, and adequate organ function. Exclusions include prior HER2 therapy, uncontrolled comorbidities (ILD, cardiovascular disease), unresolved toxicity (>Grade 1), pregnancy, and prior topoisomerase I inhibitor ADCs.
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| Administration Dosage |
Enrolled Subjects will be randomized to receive a 8 mg/kg IV dose of DB-1303/BNT323 on Day 1 of each cycle Q3W
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| Related Clinical Trial | |||||
| NCT Number | NCT06018337 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02) | ||||
| Primary Endpoint |
The primary endpoint is progression-free survival (PFS) by blinded independent central review (BICR) per RECIST 1.1 in HR+, HER2-low breast cancer patients, assessed over approximately 51 months.
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| Other Endpoint |
Key secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DoR) by BICR and investigator assessment, safety (TEAEs/SAEs per CTCAE v5.0), and patient-reported outcomes (EORTC QLQ-C30/BR45, EQ-5D-5L) tracking QoL changes over 51 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Key inclusion criteria: Adults ≥18 with HER2+ metastatic breast cancer previously treated with trastuzumab/taxane, ECOG 0-1, measurable lesions per RECIST 1.1, and life expectancy ≥12 weeks. Exclusion criteria: prior HER2 ADC therapy, interstitial lung disease, drug hypersensitivity, active infections, uncontrolled comorbidities, unresolved toxicity (>Grade 1), or multiple malignancies within 3 years.
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| Administration Dosage |
Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion
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| Related Clinical Trial | |||||
| NCT Number | NCT06265428 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III, Multicenter, Open-label, Randomized Study to Compare DB-1303 Versus T-DM1 in Patients With HER2-positive Unresectable/Metastatic Breast Cancer Who Have Been Treated With Trastuzumab and a Taxane (Dynasty-Breast01) | ||||
| Primary Endpoint |
The primary endpoint is Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) per RECIST 1.1, measured from randomization to the first documented progression or death, with a time frame of up to 24 months.
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| Other Endpoint |
Secondary endpoints include Overall Survival (OS), PFS by investigator assessment, Objective Response Rate (ORR), Duration of Response (DoR), and PK parameters (Cmax, Tmax). Safety will evaluate adverse events (AEs), PROs (EORTC QLQ-C30, QLQ-BR45, EQ-5D-5L), and immunogenicity (ADA development), all assessed over approximately 24 months.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Key inclusion criteria: females ≥18 with recurrent HER2+ (IHC 1+/2+/3+) endometrial cancer (excluding sarcomas), measurable disease (RECIST 1.1), ECOG 0-2, ≥1 prior platinum line, and life expectancy ≥12 weeks. Exclusion: ineligible for comparator chemo, recent bowel obstruction, uncontrolled comorbidities (including ILD, infection), unresolved toxicity (>Grade 1), allergy to study drugs, prior topoisomerase I inhibitors, or LVEF <55%.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06340568 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III, Randomized, Multi-site, Open-label Trial of BNT323/DB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer | ||||
| Primary Endpoint |
The primary endpoint is PFS by BICR in endometrial cancer patients with prior ICI treatment, measured from randomization to tumor progression or death (assessed per RECIST 1.1), with follow-up up to 32 months.
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| Other Endpoint |
Secondary endpoints include PFS in all HER2-expressing recurrent endometrial cancer patients, OS (up to 55 months), investigator-assessed PFS, ORR (confirmed CR/PR by BICR/investigator), DoR, and safety measures (TEAEs, treatment modifications).
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients have HER2-positive/expressing (except HER2-null for Cohort 2h) metastatic tumors resistant to standard therapy, measurable lesions (RECIST 1.1), ECOG 0-1, LVEF ≥50%, and adequate organ function. Exclusions: significant cardiac/lung disease, active infections, uncontrolled brain metastases, unresolved toxicity (>Grade 1), or prior malignancies (Part 2). Cohort-specific criteria apply (e.g., prior ICI for endometrial cancer in Group 9).
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| Administration Dosage |
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W
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| Related Clinical Trial | |||||
| NCT Number | NCT05150691 | 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-1303/BNT323 in Patients with Advanced/Metastatic Solid Tumors | ||||
| Primary Endpoint |
The study evaluates safety, efficacy, and pharmacokinetics of DB-1303 in HER2-positive/expressing advanced solid tumors. Primary endpoints include DLTs, AEs/SAEs graded by CTCAE v5.0, MTD/RP2D determination (Phase 1), and ORR by RECIST 1.1 (Phase 2). Special assessments include PK interactions with ritonavir/itraconazole (Cmax/AUC) and treatment-emergent abnormalities (vitals, ECG, labs, LVEF).
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| Other Endpoint |
PK parameters (AUC, Cmax, Tmax, T1/2, Ctrough) and immunogenicity (ADA levels) are measured in both phases. Efficacy metrics include DCR, DoR, TTR, PFS, OS (Cohort b). Phase 2 assesses time on therapy, target lesion changes, and ORR (IRC/investigator). Safety monitoring covers SAEs, TEAEs (≥G3), dose modifications, and organ function.
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
44.20
50.00 38.50 66.70 50.00 50.00 33.30 % |
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| Patients Enrolled |
Pretreated advanced or metastatic solid tumors; Histologically confirmed HER2-positive or HER2- expressing cancers.
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| Administration Dosage |
2.20 - 12.00 mg/kg Q3W.
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| Related Clinical Trial | |||||
| NCT Number | NCT05150691 | Clinical Status | Phase 1/2 | ||
| Clinical Description | A phase 1/2a, multicenter, open-label, non-randomized first in human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1303 in patients with advanced/metastatic solid tumors. | ||||
References