Pharmaceutical sponsor
EMD Serono Research & Development Institute, Inc. Clinical Trials
Studies where EMD Serono Research & Development Institute, Inc. is the lead sponsor: its pipeline by phase, what is enrolling now and where. Studies it supports as a collaborator are in the search.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 8Advanced 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
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.
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.
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.
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.
Completed, with results posted
All –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 Solid Tumors
First in Human Study of M6223
The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), immunogenicity and (if observed) the maximum tolerated dose (MTD) of M6223 as a single agent (Part 1A) for both the every 2 weeks…
- Trial name
- NCT04457778
- Testing
- M6223, Bintrafusp alfa
- Where
- 4 sites in United States, Canada
- Volunteers
- 58 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Lung Cancer, Cancer
Bintrafusp Alfa Program Rollover Study
This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706…
- Trial name
- NCT05061823
- Testing
- Bintrafusp alfa
- Where
- 21 sites in United States, Belgium and 10 more
- Volunteers
- 22 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Sclerosis
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
To evaluate the effectiveness, safety and Patient-Reported Outcomes (PROs) of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis…
- Trial name
- NCT03933202
- Testing
- Cladribine Tablets
- Where
- 66 sites in United States
- Volunteers
- 291 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus…
- Trial name
- NCT05162586
- Testing
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 456 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.