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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:
16d
YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer (clinicaltrials.gov)
P3, N=376, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
gemcitabine • capecitabine • eribulin mesylate • vinorelbine tartrate • Trodelvy (sacituzumab govitecan-hziy) • BNT326
26d
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. | Trial primary completion date: Dec 2025 --> Dec 2026
Trial primary completion date • First-in-human
|
HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
|
EGFR mutation • HR positive • HER-2 negative • EGFR L858R • EGFR exon 19 deletion • HR positive + HER-2 negative
|
BNT326
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
Trial initiation date
|
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) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
KRAS mutation • BRAF mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • PD-L1 negative • RET mutation • MET mutation • EGFR negative
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pumitamig (BNT327) • BNT326 • MK-3475 SC
1m
BNT326-01: 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=980, Recruiting, BioNTech SE | N=329 --> 980
Enrollment change • Trial initiation date
|
HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • EGFR mutation • HR positive • BRAF mutation • HER-2 negative • EGFR L858R • HER-2 expression • EGFR exon 19 deletion • ALK rearrangement • PD-L1 expression + HER-2 overexpression • HER-2 negative + HR negative
|
itraconazole • pumitamig (BNT327) • BNT326
2ms
Pivotal study to evaluate YL202 versus Docetaxel in Patients with Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer (ChiCTR2600120457)
P3, N=440, Shanghai Dongfang Hospital; Shanghai Dongfang Hospital
New P3 trial
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
docetaxel • BNT326
2ms
BNT326-01: 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=280, Recruiting, BioNTech SE
New P1/2 trial
|
itraconazole • pumitamig (BNT327) • BNT326
2ms
BNT326-01: 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=280, Recruiting, BioNTech SE | N=172 --> 280
Enrollment change
|
itraconazole • pumitamig (BNT327) • BNT326
3ms
YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer (clinicaltrials.gov)
P3, N=376, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
New P3 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
gemcitabine • capecitabine • eribulin mesylate • vinorelbine tartrate • Trodelvy (sacituzumab govitecan-hziy) • BNT326
3ms
A Study of YL202 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2, N=100, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
|
BNT326
4ms
Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
P3, N=440, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
New P3 trial
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
docetaxel • BNT326
4ms
BNT326-01: 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 (2024-517261-16-00)
P1/2, N=172, Recruiting, BioNTech SE
New P1/2 trial
|
pumitamig (BNT327) • 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) (2024-519344-32-00)
P1/2, N=88, Not yet recruiting, BioNTech SE
New P1/2 trial
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • pumitamig (BNT327) • BNT326
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