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BNT323
i
Other names: BNT323, DB-1303, BNT 323, DB1303, DB 1303, BNT-323
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News alerts, weekly reports and conference planners
Company:
BioNTech, DualityBio
Drug class:
Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
Related drugs:
2ms
ENGOT- en25: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients with Recurring Uterine Cancer (clinicaltrials.gov)
P3, N=468, Not yet recruiting, BioNTech SE | Trial completion date: Dec 2028 --> Mar 2029 | Initiation date: Aug 2024 --> Nov 2024
Trial completion date • Trial initiation date
|
paclitaxel • doxorubicin hydrochloride • BNT323
3ms
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=766, Recruiting, DualityBio Inc. | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Jun 2025 --> Apr 2026
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
Perjeta (pertuzumab) • BNT323 • itraconazole • ritonavir
6ms
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov)
P3, N=468, Not yet recruiting, BioNTech SE | Trial completion date: Aug 2028 --> Dec 2028 | Initiation date: Apr 2024 --> Aug 2024 | Trial primary completion date: Oct 2026 --> Feb 2027
Trial completion date • Trial initiation date • Trial primary completion date
|
paclitaxel • doxorubicin hydrochloride • BNT323
8ms
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov)
P3, N=468, Not yet recruiting, BioNTech SE
New P3 trial
|
paclitaxel • doxorubicin hydrochloride • BNT323
9ms
A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer (clinicaltrials.gov)
P3, N=224, Recruiting, DualityBio Inc.
New P3 trial • Metastases
|
Kadcyla (ado-trastuzumab emtansine) • BNT323
9ms
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (clinicaltrials.gov)
P3, N=532, Recruiting, DualityBio Inc. | Not yet recruiting --> Recruiting
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
|
HER-2 positive • HER-2 expression • HER-2 underexpression • PGR positive
|
capecitabine • albumin-bound paclitaxel • BNT323
1year
A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=631, Recruiting, DualityBio Inc. | N=463 --> 631
Enrollment change • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 expression
|
Perjeta (pertuzumab) • BNT323 • itraconazole • ritonavir
1year
A Study of DB-1303 vs Investigator's Choice Chemotherapy in Metastatic Breast Cancer (clinicaltrials.gov)
P3, N=466, Not yet recruiting, DualityBio Inc.
New P3 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
|
HER-2 positive • HER-2 expression • HER-2 underexpression • PGR positive
|
capecitabine • albumin-bound paclitaxel • BNT323
over1year
DB-1303, A HER2-Targeting ADC, For Patients With Advanced/Metastatic Endometrial Cancer: Preliminary Clinical Results From An Ongoing Phase 1/2a Trial (NCT05150691) (ESGO 2023)
No interstitial lung disease occurred. Conclusion DB-1303 demonstrated a manageable safety profile and promising antitumor activity, with high disease control in patients with advanced/metastatic EC.
Clinical • P1/2 data • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 expression
|
BNT323
over1year
Preclinical pharmacokinetics in cynomolgus monkeys and first in human dose prediction of DB-1303, a HER2-targeting antibody-drug conjugate (AACR 2023)
DB-1303 exhibited favorable PK characteristics of DB-1303 in cynomolgus monkeys, and is predicted to have large safety margins at the selected doses in the first in human study. At the time of presentation, the first-in-human phase 1/2 study in patients with advanced solid tumors is in progress (NCT05150691).
P1 data • PK/PD data • Preclinical
|
HER-2 (Human epidermal growth factor receptor 2)
|
BNT323
2years
A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=360, Recruiting, DualityBio Inc. | N=180 --> 360
Enrollment change • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 expression
|
BNT323
2years
DB-1303, a HER2-targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising safety profile and anti-tumor efficacy with differentiation from DS-8201a (AACR-NCI-EORTC 2022)
l In vivo, DB-1303 induced dose-dependent tumor growth inhibition and tumor regression in T-DM1-resistant JIMT-1 xenograft model, HER2 low-expressing Ishikawa xenograft and two HER2-low breast cancer PDX models. At the time of presentation, a first-in-human phase 1/2 study in patients with advanced solid tumors is in progress (NCT05150691). No
Clinical
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 negative • HER-2 expression • HER-2 underexpression
|
Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • BNT323
over2years
A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=140, Recruiting, DualityBio Inc. | Not yet recruiting --> Recruiting
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 expression
|
BNT323
almost3years
A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=140, Not yet recruiting, DualityBio Inc.
New P1/2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 expression
|
BNT323
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