Skip to main content

Table 1 Clinical trials for MSLN-targeted therapies based on antibody-based drugs and vaccines

From: Mesothelin as a biomarker for targeted therapy

Agent NCT Number (Reference) Title Status (Results) Interventions Phases Enrollment Start Date Locations
SS1P NCT01445392 [46] SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma Terminated Biological: Multicycle SS1P
Drug: Pemetrexed
Drug: Cisplatin
Biological: Single cycle SS1PBiological: Multicycle SS1P
Drug: Pemetrexed
Drug: Cisplatin
Biological: Single cycle SS1PBiological: Multicycle SS1P
Drug: Pemetrexed
Drug: Cisplatin
Biological: Single cycle SS1P
Phase 1 24 2007-11-14 United States
NCT01362790 [47] SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma Unknown status (Results Submitted) Drug: Pentostatin; Drug: Cyclophosphamide; Biological: SS1(dsFv)PE38 - lot 073I0809; Biological: SS1(dsFv)PE38 - lot FIL129J01 Phase 1/2 55 2011-05-11 United States
NCT01051934 A Phase I Trial of SS1 (dsFv) PE38 With Paclitaxel, Carboplatin, and Bevacizumab in Subjects With Unresectable Non-Small Cell Lung Adenocarcinoma Completed Drug: SS1 (dsFv) PE38; Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab Phase 1 2 2009-12-29 United States
NCT00066651 [48] Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors Completed Biological: SS1(dsFv)-PE38 immunotoxin Phase 1   2003-07-01 United States
NCT00006981 [49] Immunotoxin Therapy in Treating Patients With Advanced Cancer Completed Biological: SS1(dsFv)-PE38 immunotoxin Phase 1   2000-12-01 United States
Amatuximab NCT02357147 [50] Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM) Terminated Drug: Placebo; Drug: Amatuximab; Drug: Pemetrexed; Drug: Cisplatin Phase 2 108 2015-11-03 Australia; France; Germany; Italy; United Kingdom; United States
NCT01521325 A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers Completed Drug: Amatuximab Phase 1 6 2011-09-01 United States
NCT01413451 Amatuximab for High Mesothelin Cancers Terminated Drug: Amatuximab (MORab-009) Early Phase 1 7 2011-07-12 United States
NCT01018784 [51] A Study of MORAb-009 in Patients With Solid Tumor Completed Drug: MORAb-009 Phase 1 17 2009-11-01 Japan
NCT00738582 [52,53,54] An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma Completed (Results Submitted) Drug: MORAb-009(Amatuximab); Drug: Pemetrexed; Drug: Cisplatin Phase 2 89 2008-12-01 Canada; Germany; Netherlands; Spain; United States
NCT00570713 [52] An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer Completed (Results Available) Drug: MORAb-009; Drug: Placebo; Drug: Placebo; Drug: Gemcitabine Phase 2 155 2007-12-01 Belgium; Canada; Germany; Spain; United States
NCT00325494 A Study of MORAb-009 in Subjects With Pancreatic Cancer, Mesothelioma, or Certain Types of Ovarian or Lung Cancer Completed Drug: MORAb-009 Phase 1 24 2006-05-01 United States
Anetumab ravtansine (BAY94–9343) NCT03816358 Anetumab Ravtansine With Nivolumab, Ipilimumab and Gemcitabine Hydrochloride in Treating Patients With Mesothelin Positive Advanced Pancreatic Cancer Suspended Biological: Anetumab Ravtansine; Drug: Gemcitabine Hydrochloride; Biological: Ipilimumab; Biological: Nivolumab Phase 1 64 2019-07-01 Canada
NCT03455556 Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer Recruiting Biological: Anetumab Ravtansine; Biological: Atezolizumab; Other: Laboratory Biomarker Analysis Phase 1/2 49 2018-08-10 United States
NCT03126630 Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma Recruiting Biological: Anetumab Ravtansine; Other: Laboratory Biomarker Analysis; Biological: Pembrolizumab; Other: Pharmacological Study Phase 1/2 134 2018-02-08 United States; Canada
NCT03102320 Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors Recruiting Drug: Cisplatin; Drug: Gemcitabine; Drug: Anetumab ravtansine (BAY94–9343) Phase 1 348 2017-05-26 United States; Australia; Belgium; Canada; France; Germany; Italy; Korea; Netherlands; Singapore; Spain; Switzerland; United Kingdom
NCT03023722 Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer Recruiting Drug: anetumab ravtansine Phase 2 30 2017-05-11 United States
NCT02824042 Thorough ECG (Electrocardiogram) and Drug Interaction Study With Anetumab Ravtansine and Itraconazole Active, not recruiting Drug: Anetumab ravtansine (BAY94–9343); Drug: Itraconazole Phase 1 63 2016-09-12 United States; Australia; Belgium; France; Netherlands; Spain
NCT02839681 Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine for Mesothelin Expressing Lung Adenocarcinoma Terminated (Results Submitted) Drug: Anetumab Ravtansine; Device: Blood test Phase 2 2 2016-07-19 United States
NCT02751918 [55] Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer Recruiting Drug: Anetumab ravtansine (BAY94–9343); Drug: Pegylated Liposomal Doxorubicin Phase 1 71 2016-06-08 United States; Belgium; France; Japan; Moldova; Spain
NCT02696642 Phase I Study of Anetumab Ravtansine in Hepatic or Renal Impairment Active, not recruiting Drug: Anetumab ravtansine (BAY94–9343) Phase 1 54 2016-04-14 France; Moldova
NCT02639091 Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors Active, not recruiting Drug: BAY 94–9343; Drug: Pemetrexed; Drug: Cisplatin Phase 1 36 2016-02-03 United States; Italy
NCT02610140 Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM) Active, not recruiting Drug: Anetumab ravtansine (BAY 94–9343); Drug: Vinorelbine Phase 2 248 2015-12-03 United States; Australia; Belgium; Canada; Finland; France; Italy; Korea; Netherlands; Poland; Russian Federation; Spain; Turkey; United Kingdom
NCT02485119 Phase I Dose Escalation Study of BAY94–9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies Completed Drug: BAY94–9343 Phase 1 12 2015-08-14 Japan
NCT01439152 [56] Phase I Study to Determine the Maximum Tolerable Dose of BAY94–9343 in Patients With Advanced Solid Tumors. Active, not recruiting Drug: BAY94–9343; Drug: BAY94–9343 (Expansion); Drug: BAY94–9343 (1.8 mg/kg); Drug: BAY94–9343 (2.2 mg/kg) Phase 1 147 2011-09-07 United States
DMOT4039A NCT01469793 A Study of DMOT4039A in Participants With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer Completed Drug: DMOT4039A Phase 1 71 2011-11-01 United States
NCT01832116 89Zr-MMOT PET Imaging in Pancreatic and Ovarian Cancer Patients Completed Drug: 89Zr-MMOT0530A Phase 1 11 2013-03-01 Netherlands
BMS-986148 NCT02884726 [57] Phase 1 Study of Mesothelin-ADC Completed Drug: BMS-986148 Phase 1 8 2016-10-14 Japan
NCT02341625 [57] A Study of BMS-986148 in Patients With Select Advanced Solid Tumors Active, not recruiting Drug: BMS-986148; Biological: Nivolumab Phase 1/2 407 2015-06-17 United States; Australia; Belgium; Canada; Italy; Netherlands; United Kingdom
LMB-100 NCT03644550 Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma Recruiting Drug: LMB-100; Biological: Pembrolizumab Phase 2 38 2018-12-04 United States
NCT03436732 Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma Suspended Drug: LMB-100; Drug: SEL-110 Phase 1 23 2018-02-28 United States
NCT02810418 Mesothelin-Targeted Immunotoxin LMB-100 Alone or in Combination With Nab-Paclitaxel in People With Previously Treated Metastatic and/or Locally Advanced Pancreatic Ductal Adenocarcinoma and Mesothelin Expressing Solid Tumors Active, not recruiting Drug: LMB-100; Drug: Nab-Paclitaxel; Device: Mesothelin Expression Phase 1/2 40 2016-08-03 United States
NCT02798536 Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma Active, not recruiting Drug: LMB-100; Drug: nab-paclitaxel Phase 1 21 2016-06-10 United States
BAY2287411 NCT03507452 First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin Recruiting Drug: BAY2287411 Phase 1 228 2018-06-13 United States; Finland; Netherlands; Sweden; United Kingdom
HPN536 NCT03872206 Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression Recruiting Biological: HPN536 Phase 1/2 87 2019-04-16 United States
CRS-207 NCT02004262 Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting Completed (Results Available) Biological: GVAX Pancreas Vaccine; Biological: CRS-207; Drug: Chemotherapy; Drug: cyclophosphamide Phase 2 303 2014-02-05 Canada
NCT01417000 [58] Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer Completed (Results Available) Biological: GVAX Pancreas; Biological: CRS-207; Drug: Cyclophosphamide Phase 2 93 2011-09-21 United States
NCT00585845 [59] Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment Terminated Biological: CRS-207, Live-attenuated Listeria monocytogenes expressing human Mesothelin Phase 1 17 2007-12-01 United States; Israel
JNJ-64041757 NCT03371381 An Efficacy and Safety Study of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Participants With Advanced Adenocarcinoma of the Lung Terminated Biological: JNJ-64041757; Drug: Nivolumab Phase 1/2 12 2018-01-02 United States; Belgium; Spain
NCT02592967 Safety & Immunogenicity of JNJ-64041757, Live-attenuated Double-deleted Listeria Immunotherapy, in Subjects With Non Small Cell Lung Cancer Terminated Biological: JNJ-64041757(Cohort 1A and 1B);Biological: JNJ-64041757(Cohort 2A and 2B) Phase 1 18 2015-12-02 United States
Neoantigen DNA Vaccine NCT03122106 Neoantigen DNA Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy Recruiting Biological: Personalized neoantigen DNA vaccine; Device: TDS-IM Electrode Array System; Procedure: Peripheral blood draws Phase 1 15 2018-01-05 United States