gotistobart (BNT316) / OncoC4, BioNTech 
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 0 Diseases   1 Trial   1 Trial   10 News 
7 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
gotistobart (BNT316) / OncoC4, BioNTech
PRESERVE-003, NCT05671510: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

Recruiting
3
600
Europe, Canada, US, RoW
Gotistobart, A humanized anti-CTLA4 IgG1 monoclonal antibody, ONC-392, BNT316, Docetaxel, Docefrez, Taxotere
OncoC4, Inc., BioNTech SE
Non Small Cell Lung Cancer
06/26
06/27
PRESERVE-004, NCT05446298: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer

Recruiting
2
58
US
ONC-392, A humanized anti-CTLA4 IgG1 monoclonal antibody made by OncoC4, Inc., Pembrolizumab, MK3475, Keytruda
OncoC4, Inc., Merck Sharp & Dohme LLC, GOG Foundation
Ovarian Cancer, High Grade Serous Adenocarcinoma of Ovary, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
06/25
06/26
PRESERVE-001, NCT04140526: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

Recruiting
1/2
733
US, RoW
ONC-392, A humanized anti-CTLA4 IgG1 monoclonal antibody made by OncoC4, Inc., Pembrolizumab, Keytruda, MK3475, Docetaxel, Taxotere, Docefrez
OncoC4, Inc., National Cancer Institute (NCI)
Non Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Melanoma, Metastatic Head and Neck Carcinoma, Metastatic Renal Cell Carcinoma, Metastatic Colorectal Cancer, Sarcomas, Metastatic Prostate Cancer, Ovarian Cancer, Small Cell Lung Cancer, Metastatic Breast Cancer, Pancreas Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Junction Adenocarcinoma, Cervical Cancer, Adenoid Cystic Carcinoma, Salivary Gland Cancer, Urothelial Carcinoma
06/26
12/27
PRESERVE-006, NCT05682443: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC

Recruiting
1/2
144
US
ONC-392, A humanized anti-CTLA4 IgG1 monoclonal antibody, Gotistobart, lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses., Pluvicto
OncoC4, Inc., Prostate Cancer Clinical Trials Consortium
Metastatic Castration-resistant Prostate Cancer
06/26
06/27
ChiCTR2000039098: Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 in Advanced Solid Tumors and NSCLC: an Open Label Phase Ia/Ib Study.

Completed
1
48
 
ONC-392 0.1 mg/kg ;ONC-392 0.3 mg/kg ;ONC-392 1 mg/kg ;ONC-392 3 mg/kg ;ONC-392 10 mg/kg ;ONC-392 RP2D
Chinese PLA General Hospital; OncoImmune-Guangzhou, Inc., Self-financing
NSCLC
 
 
ChiCTR2300068548: Safety and Efficacy of ONC-392 Injection in Locally Advanced or Metastatic Hepatocellular Carcinoma, Esophageal Cancer, Gastric Cancer, and Anal Carcinoma: A Single Arm, Open Label, Multicenter Phase Ib Study

Recruiting
1
60
 
ONC-392 initial dose 10 mg/kg, Q3W x2 times, followed by 6mg/kg, Q3W
Sun Yat-sen University Cancer Center; Acroimmune Biotech Co, Ltd, Self-financing
Hepatocellular carcinoma, esophageal cancer, gastric cancer, and anal carcinoma
 
 
PRESERVE-009, NCT05858736: Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors

Recruiting
1
18
RoW
AI-061, Anti-PD-1 and anti-CTLA-4 in 1:1 co-formulation
OncoC4, Inc., OncoC4 AU Pty Ltd, Avance Clinical
Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, High Grade Serous Adenocarcinoma of Ovary, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Endometrial Cancer, Cervical Cancer, Renal Cell Carcinoma, Bladder Cancer, Esophageal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, Colorectal Cancer, Anal Cancer, Hepatocellular Carcinoma, Bile Duct Cancer
12/24
06/25

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