NCT04882917 is a Phase 1 clinical trial of M4076 in Advanced Solid Tumors, sponsored by EMD Serono Research & Development Institute, Inc..

Who is sponsoring NCT04882917?

NCT04882917 is sponsored by EMD Serono Research & Development Institute, Inc..

What drugs are being tested in NCT04882917?

Interventions in NCT04882917: M4076.

What condition does NCT04882917 study?

NCT04882917 studies Advanced Solid Tumors.

Is NCT04882917 still recruiting?

NCT04882917 is currently completed. Last updated 7 March 2025.

Are results published for NCT04882917?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-07 · How we verify

NCT04882917

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)

Completed Phase 1 Results posted Last updated 7 March 2025

What this trial tests

Phase 1 trial testing M4076 in Advanced Solid Tumors in 22 participants. Completed in 31 March 2023.

Timeline

24 May 2021

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	EMD Serono Research & Development Institute, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	24 May 2021
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	3 locations across Canada, United States

Drugs / interventions tested

M4076 — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

EMD Serono Research & Development Institute, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Assessed Using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0 Primary · Day 1 to Day 21 of Cycle 1 (21-day cycle)

A DLT was defined as the occurrence of any of following events that were judged by the study investigator, received at least 80% of the planned cumulative dose during the DLT period of each study intervention and completed the DLT period or additionally, participants who did not receive 80% of the planned total dose of study intervention, but at least 80% dosing of a different dose cohort and finished the DLT period are eligible for the DLT analysis set to be analyzed in the highest dose cohort for which they received 80% of dosing.

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	1
Part 1A Dose Escalation: M4076 300 mg	1
Part 1A Dose Escalation: M4076 400 mg	2

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Related TEAEs Primary · From the first dose of study drug administration until 30 days after the last dose of study drug administration (up to 603 days)

An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important

TEAEs

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	2
Part 1A Dose Escalation: M4076 200 mg	7
Part 1A Dose Escalation: M4076 300 mg	9
Part 1A Dose Escalation: M4076 400 mg	4

Treatment Related TEAEs

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	1
Part 1A Dose Escalation: M4076 200 mg	2
Part 1A Dose Escalation: M4076 300 mg	8
Part 1A Dose Escalation: M4076 400 mg	4

Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Primary · Baseline (Day 1) up to 30 days after the last dose of study drug administration (up to 603 days)

Vital sign assessments included assessments of heart rate, diastolic blood pressure, systolic blood pressure, weight, respiratory rate and temperature. Clinical significance was assessed by the investigator. Number of participants who with clinically significant changes from baseline in vital signs were reported.

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	0
Part 1A Dose Escalation: M4076 300 mg	0
Part 1A Dose Escalation: M4076 400 mg	0

Number of Participants With Change From Baseline in Laboratory Test Abnormalities to Grade 3 or Higher Severity Based on NCI-CTCAE Version 5.0 Primary · Baseline (Day 1) up to 30 days after the last dose of study drug administration (up to 603 days)

The laboratory measurements included hematology and biochemistry values were graded with National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 toxicity grades (where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = death). Number of participants with change from baseline to grade 3 or higher values for the hematology and biochemistry were reported.

Grade>=3 Alanine Aminotransferase High

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	0
Part 1A Dose Escalation: M4076 300 mg	0
Part 1A Dose Escalation: M4076 400 mg	1

Grade>=3 Aspartate Aminotransferase High

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	0
Part 1A Dose Escalation: M4076 300 mg	0
Part 1A Dose Escalation: M4076 400 mg	1

Grade>=3 Alkaline Phosphatase High

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	0
Part 1A Dose Escalation: M4076 300 mg	0
Part 1A Dose Escalation: M4076 400 mg	1

Grade>=3 Gamma Glutamyl Transferase High

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	0
Part 1A Dose Escalation: M4076 300 mg	0
Part 1A Dose Escalation: M4076 400 mg	1

Grade>=3 Bilirubin High

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	1
Part 1A Dose Escalation: M4076 300 mg	0
Part 1A Dose Escalation: M4076 400 mg	0

Grade>=3 Lipase High

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	1
Part 1A Dose Escalation: M4076 300 mg	0
Part 1A Dose Escalation: M4076 400 mg	0

Grade>=3 Sodium Low

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	0
Part 1A Dose Escalation: M4076 300 mg	1
Part 1A Dose Escalation: M4076 400 mg	0

Grade>=3 Potassium High

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	1
Part 1A Dose Escalation: M4076 300 mg	0
Part 1A Dose Escalation: M4076 400 mg	0

Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Values Primary · Baseline (Day 1) up to 30 days after the last dose of study drug administration (up to 603 days)

ECG parameters included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, QT intervals, and corrected QT(QTc) intervals. Clinical significance was determined by the investigator. Number of participants with clinically significant change from baseline in 12-lead ECG were reported.

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0
Part 1A Dose Escalation: M4076 200 mg	0
Part 1A Dose Escalation: M4076 300 mg	0
Part 1A Dose Escalation: M4076 400 mg	0

Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator Secondary · Time from first study treatment up to 603 days

Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR).

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	0	0.00 – 84.19
Part 1A Dose Escalation: M4076 200 mg	0	0.00 – 40.96
Part 1A Dose Escalation: M4076 300 mg	0	0.00 – 33.63
Part 1A Dose Escalation: M4076 400 mg	0	0 – 15.44

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigators Secondary · Time from the first dose of study intervention until occurrence of PD, death due to any cause or last tumor assessment (assessed up to 603 days)

PFS is defined as the time (in months) from date of first administration of study intervention to the date of the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was to be estimated using Kaplan-Meier (KM) plots.

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	NA	NA – NA
Part 1A Dose Escalation: M4076 200 mg	1.1	0.20 – 1.58
Part 1A Dose Escalation: M4076 300 mg	1.3	0.69 – 2.60
Part 1A Dose Escalation: M4076 400 mg	NA	1.22 – NA

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Sampling Time (AUClast) of M4076 Secondary · Day 1 and Day 8

Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-tlast was to be calculated according to the mixed log-linear trapezoidal rule.

Day 1

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	NA	± NA
Part 1A Dose Escalation: M4076 200 mg	37000	± 34.1
Part 1A Dose Escalation: M4076 300 mg	50500	± 45.1
Part 1A Dose Escalation: M4076 400 mg	76600	± 44.3

Day 8

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	NA	± NA
Part 1A Dose Escalation: M4076 200 mg	36500	± 109.2
Part 1A Dose Escalation: M4076 300 mg	56500	± 67.6
Part 1A Dose Escalation: M4076 400 mg	85900	± 40.8

Area Under Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M4076 Secondary · Day 1 and Day 8

The AUC from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from lambda z determination. AUC0-inf = AUC0-tlast +Clast pred/ lambda z (single dose only)

Day 1

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	NA	± NA
Part 1A Dose Escalation: M4076 200 mg	39200	± 40.3
Part 1A Dose Escalation: M4076 300 mg	44900	± 49.9
Part 1A Dose Escalation: M4076 400 mg	69800	± 20.4

Maximum Observed Plasma Concentration (Cmax) of M4076 Secondary · Day 1 and Day 8

Cmax was obtained directly from the concentration versus time curve.

Day 1

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	NA	± NA
Part 1A Dose Escalation: M4076 200 mg	4080	± 26.5
Part 1A Dose Escalation: M4076 300 mg	6270	± 20.3
Part 1A Dose Escalation: M4076 400 mg	8510	± 30.1

Day 8

Group	Value	95% CI
Part 1A Dose Escalation: M4076 100 mg	NA	± NA
Part 1A Dose Escalation: M4076 200 mg	4690	± 52.5
Part 1A Dose Escalation: M4076 300 mg	6730	± 26.3
Part 1A Dose Escalation: M4076 400 mg	9600	± 22.8

Absolute Values in Ataxia-Telangiectasia Mutated (ATM) Pathway Readouts Assessed by Flow Cytometry and Immunohistochemistry: Gamma-H2AX Secondary · Baseline up to Day 23

gamma-H2AX is measured by flow cytometry and immunohistochemistry. Absolute values were reported for each participant as descriptive data for this outcome measure was not calculated. P= Part, D=Day, H=Hour in the below mentioned categories. Mean Fluorescent Intensity (MFI) is a number generated by the flow cytometer; an instrument that measures the fluorescent signal emitted by a sample. The stronger the fluorescent signal, the higher the MFI value detected by the instrument's acquisition software. The values displayed in the system represent each MFI measurement at different time points, with

Participant1(P1AD1-2H Postdose)

Group	Value	95% CI
Part 1A Dose Escalation: M4076 mg (All Participants)	1316

Participant1(P1AD1-4H Postdose)

Group	Value	95% CI
Part 1A Dose Escalation: M4076 mg (All Participants)	1037

Participant1(P1AD1-6H Postdose)

Group	Value	95% CI
Part 1A Dose Escalation: M4076 mg (All Participants)	3127

Participant1(P1AD1-Predose)

Group	Value	95% CI
Part 1A Dose Escalation: M4076 mg (All Participants)	1612

Participant1(P1AD2-2-4H Postdose)

Group	Value	95% CI
Part 1A Dose Escalation: M4076 mg (All Participants)	347

Participant1(P1AD2-Predose)

Group	Value	95% CI
Part 1A Dose Escalation: M4076 mg (All Participants)	1925

Participant1(P1A/1BD22-2H Postdose

Group	Value	95% CI
Part 1A Dose Escalation: M4076 mg (All Participants)	1030

Participant1(P1A/1BD22-4H Postdose)

Group	Value	95% CI
Part 1A Dose Escalation: M4076 mg (All Participants)	1023

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 603 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1A Dose Escalation: M4076 100 mg

Serious: 0/2 (0%)

Deaths: 0/2

Part 1A Dose Escalation: M4076 200 mg

Serious: 4/7 (57%)

Deaths: 4/7

Part 1A Dose Escalation: M4076 300 mg

Serious: 2/9 (22%)

Deaths: 1/9

Part 1A Dose Escalation: M4076 400 mg

Serious: 3/4 (75%)

Deaths: 0/4

Serious adverse events (19 terms)

Reaction	System	Part 1A Dose Escalation: M…	Part 1A Dose Escalation: M…	Part 1A Dose Escalation: M…	Part 1A Dose Escalation: M…
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Immune system disorder	Immune system disorders	—	—	—	—
Enterocolitis infectious	Infections and infestations	—	—	—	—
Liver abscess	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Spontaneous bacterial peritonitis	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Urinary tract stoma complication	Injury, poisoning and procedural complications	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—

Other adverse events (60 terms — click to expand)

Reaction	System	Part 1A Dose Escalation: M…	Part 1A Dose Escalation: M…	Part 1A Dose Escalation: M…	Part 1A Dose Escalation: M…
Fatigue	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—
Eye irritation	Eye disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Gait disturbance	General disorders	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—
Enterocolitis infectious	Infections and infestations	—	—	—	—
Liver abscess	Infections and infestations	—	—	—	—
Oral candidiasis	Infections and infestations	—	—	—	—
Osteomyelitis	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Skin infection	Infections and infestations	—	—	—	—
Spontaneous bacterial peritonitis	Infections and infestations	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—
White blood cell count increased	Investigations	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—

Most-reported serious reactions: Rash maculo-papular, Abdominal pain, Nausea, Vomiting, Pyrexia, Immune system disorder, Enterocolitis infectious, Liver abscess.

Data from ClinicalTrials.gov NCT04882917 adverse events section.

Sponsor's own description

The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumors in dose escalation (Part 1A). Once the recommended dose for expansion (RDE) was declared in Part 1A, a preliminary food effect cohort, Part 1B, will follow at the RDE determined from Part 1A.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
A new wave of innovations within the DNA damage response.
Li Q, Qian W, Zhang Y, Hu L, et al · · 2023 · cited 85× · PMID 37679326 · DOI 10.1038/s41392-023-01548-8
Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103
Consensus, debate, and prospective on pancreatic cancer treatments.
Wang J, Yang J, Narang A, He J, et al · · 2024 · cited 56× · PMID 39390609 · DOI 10.1186/s13045-024-01613-x
DNA Damage and Its Role in Cancer Therapeutics.
Moon J, Kitty I, Renata K, Qin S, et al · · 2023 · cited 47× · PMID 36902170 · DOI 10.3390/ijms24054741
Targeting the DNA Damage Response and DNA Repair Pathways to Enhance Radiosensitivity in Colorectal Cancer.
Deng S, Vlatkovic T, Li M, Zhan T, et al · · 2022 · cited 40× · PMID 36230796 · DOI 10.3390/cancers14194874
Phase I trial of ATM inhibitor M3541 in combination with palliative radiotherapy in patients with solid tumors.
Waqar SN, Robinson C, Olszanski AJ, Spira A, et al · · 2022 · cited 40× · PMID 35150356 · DOI 10.1007/s10637-022-01216-8
A New Class of Selective ATM Inhibitors as Combination Partners of DNA Double-Strand Break Inducing Cancer Therapies.
Zimmermann A, Zenke FT, Chiu LY, Dahmen H, et al · · 2022 · cited 35× · PMID 35405736 · DOI 10.1158/1535-7163.mct-21-0934

Verify or expand the search:

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

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NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other EMD Serono Research & Development Institute, Inc. trials

Trials by the same sponsor.

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NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07166601 — M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid · Phase 1 · recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04882917 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc.
Last refreshed: 7 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04882917.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04882917

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (19 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Advanced Solid Tumors

Other EMD Serono Research & Development Institute, Inc. trials

Verify against primary sources