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