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BNT327
i
Other names: BNT 327, BNT-327, BNT327, PM8002, PM 8002, PM-8002
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Company:
BioNTech, Biotheus
Drug class:
PD-L1 inhibitor, VEGF-A inhibitor
Related drugs:
14h
PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (clinicaltrials.gov)
P3, N=404, Recruiting, Biotheus Inc. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
paclitaxel • topotecan • BNT327
13d
PM8002-A001: PM8002 in the Treatment of Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=380, Recruiting, Biotheus Inc. | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2025
Trial completion date • Trial primary completion date • Metastases
|
BNT327
17d
Safety and Effectiveness of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer (clinicaltrials.gov)
P3, N=439, Not yet recruiting, BioNTech SE
New P3 trial • Combination therapy
|
Tecentriq (atezolizumab) • carboplatin • etoposide IV • BNT327
17d
Safety, Effectiveness, and Pharmacokinetics (the Movement of Drug Into, Through and Out of the Body) of BNT327 (an Investigational Therapy) in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (clinicaltrials.gov)
P2/3, N=982, Not yet recruiting, BioNTech SE
New P2/3 trial • Combination therapy
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • BNT327
1m
PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (ChiCTR2400091077)
P3, N=404, Recruiting, Jilin Cancer Hospital; Jilin Cancer Hospital
New P3 trial • Combination therapy
|
paclitaxel • topotecan • BNT327
2ms
Interim Overall Survival of Patients with Locally Advanced or Metastatic Triple-Negative Breast Cancer treated wtih First Line PM8002/BNT327 in Combination with Nab-Paclitaxel in Phase Ib/II Study. (SABCS 2024)
In pts with LA/mTNBC, first-line therapy with PM8002/BNT327 combined with nab-paclitaxel showed clinically meaningful survival outcomes and antitumor activity regardless of PD-L1 status, together with a manageable safety profile. No new safety signals were observed beyond those typically described for anti-PD-1/PD-L1 and anti-VEGF therapies and nab-paclitaxel. A randomized controlled Phase III clinical trial (NCT06419621) of first-line treatment of TNBC in China and a global Phase II trial (NCT06449222) are ongoing in TNBC.
Clinical • P1/2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 expression
|
AmoyDx® PD-L1 Expression Detection Kit
|
albumin-bound paclitaxel • BNT327
3ms
PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (clinicaltrials.gov)
P3, N=404, Not yet recruiting, Biotheus Inc.
New P3 trial • Combination therapy
|
paclitaxel • topotecan • BNT327
4ms
A Clinical Trial to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC (clinicaltrials.gov)
P1/2, N=140, Not yet recruiting, Biotheus Inc.
New P1/2 trial • Metastases
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • BNT327
4ms
BNT327-01: Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov)
P2, N=110, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
BNT327
4ms
BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov)
P2, N=60, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
BNT327
4ms
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC (clinicaltrials.gov)
P2/3, N=374, Active, not recruiting, Biotheus Inc. | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • IO biomarker • Metastases
|
carboplatin • pemetrexed • BNT327
5ms
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
P3, N=360, Recruiting, Biotheus Inc. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
albumin-bound paclitaxel • BNT327
5ms
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov)
P2, N=110, Not yet recruiting, BioNTech SE | Trial completion date: Apr 2026 --> Aug 2026
Trial completion date • Combination therapy
|
BNT327
5ms
BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov)
P2, N=60, Not yet recruiting, BioNTech SE | Trial completion date: Apr 2026 --> Jan 2027
Trial completion date • Combination therapy
|
BNT327
6ms
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=842, Recruiting, DualityBio Inc. | N=607 --> 842
Enrollment change • Metastases
|
Keytruda (pembrolizumab) • BNT327
6ms
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov)
P2, N=110, Not yet recruiting, BioNTech SE
New P2 trial • Combination therapy
|
BNT327
6ms
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov)
P2, N=60, Not yet recruiting, BioNTech SE
New P2 trial • Combination therapy
|
BNT327
7ms
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
P3, N=360, Not yet recruiting, Biotheus Inc.
New P3 trial • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
albumin-bound paclitaxel • BNT327
11ms
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC (clinicaltrials.gov)
P2/3, N=445, Recruiting, Biotheus Inc. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
Tecentriq (atezolizumab) • etoposide IV • BNT327
over1year
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC (clinicaltrials.gov)
P2/3, N=374, Recruiting, Biotheus Inc. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • IO biomarker • Metastases
|
PD-L1 expression • EGFR mutation
|
carboplatin • pemetrexed • BNT327
over1year
A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM (clinicaltrials.gov)
P2, N=55, Recruiting, Biotheus Inc.
New P2 trial • Combination therapy
|
cisplatin • carboplatin • pemetrexed • BNT327
over1year
A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC (clinicaltrials.gov)
P1/2, N=60, Recruiting, Biotheus Inc.
New P1/2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative
|
albumin-bound paclitaxel • BNT327
over1year
PM8002 in the Treatment of Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=380, Recruiting, Biotheus Inc.
New P1/2 trial • Metastases
|
BNT327
over1year
A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC (clinicaltrials.gov)
P2, N=99, Recruiting, Biotheus Inc.
New P2 trial • Combination therapy
|
paclitaxel • BNT327
over1year
A Study of PM8002 Injection in Combination With Chemotherapy in Patients With NEN (clinicaltrials.gov)
P2, N=60, Recruiting, Biotheus Inc.
New P2 trial • Combination therapy
|
5-fluorouracil • irinotecan • leucovorin calcium • BNT327
over1year
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma (clinicaltrials.gov)
P2, N=35, Recruiting, Biotheus Inc.
New P2 trial • Combination therapy
|
5-fluorouracil • oxaliplatin • leucovorin calcium • BNT327
over1year
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC (clinicaltrials.gov)
P2/3, N=445, Not yet recruiting, Biotheus Inc.
New P2/3 trial • Combination therapy
|
Tecentriq (atezolizumab) • etoposide IV • BNT327
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