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BNT326
i
Other names: BNT326, YL202, BNT 326, YL 202, BNT-326, YL-202
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News alerts, weekly reports and conference planners
Company:
BioNTech, MediLink
Drug class:
Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate
Related drugs:
1m
BNT326-02: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
P1/2, N=420, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
Enrollment open
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pumitamig (BNT327) • BNT326 • MK-3475 SC
2ms
A Study of YL202 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2, N=100, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
New P2 trial
|
BNT326
3ms
A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=414, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
New P1/2 trial
|
Loqtorzi (toripalimab-tpzi) • Ivesa (firmonertinib) • BNT326
4ms
BNT326-02: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
P1/2, N=420, Not yet recruiting, BioNTech SE
New P1/2 trial
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pumitamig (BNT327) • BNT326 • MK-3475 SC
4ms
A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients with Advanced Solid Tumors (ChiCTR2500105373)
P2, N=620, Recruiting, Jilin Cancer Hospital; Jilin Cancer Hospital
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
BRAF V600E • KRAS mutation • HR positive • KRAS G12C • HER-2 negative • BRAF V600 • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • RET fusion • EGFR exon 20 insertion • MET exon 14 mutation • BRAF wild-type • EGFR L861Q • RAS mutation • ALK mutation • RET mutation • RAS wild-type • ROS1 fusion • EGFR G719X • MET mutation • EGFR S768I • KRAS G12 • EGFR exon 20 mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + BRCA mutation • NTRK fusion
|
BNT326
5ms
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov)
P1/2, N=550, Not yet recruiting, BioNTech SE
New P1/2 trial
|
itraconazole • pumitamig (BNT327) • BNT326
1year
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC (clinicaltrials.gov)
P2, N=180, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting --> Recruiting
Enrollment open • Metastases
|
BNT326
1year
A Study of YL202 in Selected Patients with Advanced Solid Tumors (clinicaltrials.gov)
P2, N=200, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting --> Recruiting
Enrollment open • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
BNT326
1year
A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Subjects With Locally Advanced or Metastatic Breast Cancer Who Are TNBC and HR Positive, HER2 Zero, or HER2 Hypoactive (ChiCTR2400089158)
P2, N=180, Recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
New P2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HR positive • HER-2 negative • HER-2 expression • HER-2 underexpression • PGR expression • HER-2 negative + HR negative
|
BNT326
1year
YL202-INT-101-01: A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov)
P1, N=80, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting --> Recruiting | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
Enrollment open • Trial completion date • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
|
EGFR mutation • HR positive • HER-2 negative • EGFR L858R • EGFR exon 19 deletion • HR positive + HER-2 negative • PTEN mutation + HR positive
|
BNT326
over1year
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC (clinicaltrials.gov)
P2, N=180, Active, not recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Active, not recruiting | Initiation date: Jul 2024 --> Apr 2024
Enrollment closed • Trial initiation date • Metastases
|
BNT326
over1year
YL202-INT-101-01: A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov)
P1, N=80, Active, not recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
|
BNT326
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