Clinical trials: sponsored by EMD Serono Research & Development Institute, Inc.
Solid Tumors, Gastric Cancer
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
The PROCEADE PanTumor study aims to investigate M9140 in multiple tumor types which express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and it is therefore designed as a matrix study.
- Conditions
- Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer
- Trial name
- NCT06710132
- Testing
- M9140
- Where
- 81 sites in United States, Australia and 8 more
- Volunteers
- 184 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Advanced Solid Tumors
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known…
- Trial name
- NCT07360314
- Testing
- M7437
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 138 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Metastatic Colorectal Cancer
A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an…
- Trial name
- NCT07549412
- Testing
- Precemtabart tocentecan, Bevacizumab, Trifluridine/Tipiracil (FTD-TPI)
- Where
- 92 sites in United States, Argentina and 16 more
- Volunteers
- 1,020 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Advanced Solid Tumor
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also…
- Trial name
- TITER (NCT07166601)
- Testing
- M0324, Pembrolizumab, mFOLFIRINOX
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 77 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Advanced Solid Tumor
Anti-GD2 ADC M3554 in Advanced Solid Tumors
The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype.
- Trial name
- NCT06641908
- Testing
- M3554
- Where
- 11 sites in United States, Belgium and 4 more
- Volunteers
- 65 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- ELOWEN-1 (NCT07332481)
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 60 sites in United States, Australia and 14 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- NCT07355218
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 57 sites in United States, Australia and 15 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Cancer
Met Non Small Cell Cancer Registry (MOMENT)
The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC)…
- Trial name
- NCT05376891
- Where
- 80 sites in United States, Austria and 12 more
- Volunteers
- 700 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Locally Advanced or Metastatic Urothelial Carcinoma
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
- Trial name
- NCT05327530
- Testing
- Avelumab, Sacituzumab Govitecan (SG), M6223
- Where
- 98 sites in United States, Australia and 10 more
- Volunteers
- 256 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908_0001)…
- Trial name
- NCT07840287
- Testing
- Enpatoran
- Where
- 2 sites in United States, Germany
- Volunteers
- 404 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Solid Tumors
Avelumab Program Rollover Study
The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.
- Trial name
- NCT03815643
- Testing
- Avelumab
- Where
- 104 sites in United States, Argentina and 20 more
- Volunteers
- 205 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Ovarian Cancer
Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)
The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between…
- Trial name
- NCT06433219
- Testing
- Tuvusertib (M1774), Niraparib, Lartesertib (M4076)
- Where
- 84 sites in United States, Australia and 11 more
- Volunteers
- 63 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Non-Small Cell Lung Cancer
Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)
This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor…
- Trial name
- NCT05882734
- Testing
- M1774, Cemiplimab
- Where
- 54 sites in United States, Belgium and 6 more
- Volunteers
- 61 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Metastatic or Locally Advanced Unresectable Solid Tumors
Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)
This is an open-label, multicenter, clinical study conducted in multiple parts to establish the safety, tolerability, Pharmacokinetic/Pharmacodynamic (PK/PD) profile, maximum tolerated dose (MTD) combinations (if observed) and…
- Trial name
- NCT05396833
- Testing
- Tuvusertib, Lartesertib, Avelumab
- Where
- 22 sites in United States, Australia and 3 more
- Volunteers
- 120 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Advanced Solid Tumor
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in…
- Trial name
- NCT06421935
- Testing
- M9466, Tuvusertib, Abiraterone acetate
- Where
- 20 sites in United States, Australia and 3 more
- Volunteers
- 60 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Dermatomyositis, Polymyositis
Study of M5049 in DM and PM Participants (NEPTUNIA)
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.
- Trial name
- NCT05650567
- Testing
- M5049 dose
- Where
- 31 sites in United States, Czechia and 5 more
- Volunteers
- 20 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Non-small Cell Lung Cancer
A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor…
- Trial name
- NCT03940703
- Testing
- Tepotinib, Osimertinib
- Where
- 179 sites in United States, Belgium and 15 more
- Volunteers
- 140 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Metastatic or Locally Advanced Unresectable Solid Tumors
Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)
This is an open-label, Phase I, first-in-human (FIH) multicenter, clinical study conducted in multiple parts to establish the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile (with and without food) and…
- Trial name
- NCT04170153
- Testing
- M1774, Niraparib
- Where
- 16 sites in United States, China and 3 more
- Volunteers
- 161 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Colorectal Cancer
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors.
- Trial name
- NCT05464030
- Testing
- M9140, Bevacizumab, Capecitabine
- Where
- 35 sites in United States, Canada and 3 more
- Volunteers
- 220 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Central Nervous System Tumors
Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors
This study consists of 2 parts: Dose Escalation Part 1 and Dose Expansion Part 2. The Dose Escalation Part 1 will evaluate the safety and tolerability of Avelumab in combination with Lenvatinib and determine the recommended…
- Trial name
- NCT05081180
- Testing
- Avelumab, Lenvatinib
- Where
- 9 sites in Canada, France and 2 more
- Volunteers
- 17 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.