NCT02278250 is a Phase 1 clinical trial of M4344 10 mg BIW in Solid Tumor, sponsored by EMD Serono Research & Development Institute, Inc..

Who is sponsoring NCT02278250?

NCT02278250 is sponsored by EMD Serono Research & Development Institute, Inc..

What drugs are being tested in NCT02278250?

Interventions in NCT02278250: M4344 10 mg BIW, M4344 20 mg BIW, M4344 40 mg BIW, M4344 80 mg BIW, M4344 160 mg BIW, M4344 300 mg BIW, M4344 450 mg BIW, M4344 700 mg BIW, M4344 1050 mg BIW, M4344 1200 mg BIW, M4344 100 mg BID, M4344 150 mg QD, M4344 250 mg QD, M4344 350 mg QD, M4344 400 mg, M4344 500 mg, Carboplatin.

What condition does NCT02278250 study?

NCT02278250 studies Solid Tumor, Advanced Solid Tumor.

Is NCT02278250 still recruiting?

NCT02278250 is currently completed. Last updated 16 March 2023.

Are results published for NCT02278250?

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

Last reviewed 2023-03-16 · How we verify

NCT02278250

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 M4344 in Participants With Advanced Solid Tumors

Completed Phase 1 Results posted Last updated 16 March 2023

What this trial tests

Phase 1 trial testing M4344 10 mg BIW in Solid Tumor in 97 participants. Completed in 24 September 2021.

Timeline

26 January 2015

Primary endpoint
16 June 2021

24 September 2021

Quick facts

Lead sponsor	EMD Serono Research & Development Institute, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	97
Start date	26 January 2015
Primary completion	16 June 2021
Estimated completion	24 September 2021
Sites	16 locations across United Kingdom, Netherlands, United States, Spain

Drugs / interventions tested

M4344 10 mg BIW
M4344 20 mg BIW
M4344 40 mg BIW — full drug profile →
M4344 80 mg BIW — full drug profile →
M4344 160 mg BIW
M4344 300 mg BIW — full drug profile →
M4344 450 mg BIW
M4344 700 mg BIW
M4344 1050 mg BIW
M4344 1200 mg BIW
M4344 100 mg BID
M4344 150 mg QD
M4344 250 mg QD
M4344 350 mg QD
M4344 400 mg — full drug profile →
M4344 500 mg
Carboplatin (Carboplatin) — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →
Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

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

Who can join

18 and older, any sex, with Solid Tumor or Advanced Solid Tumor. 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.

Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Primary · up to safety follow-up visit (Week 124.9)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital

Group	Value	95% CI
Part A: M4344 10 mg BIW	2
Part A: M4344 20 mg BIW	1
Part A: M4344 40 mg BIW	2
Part A: M4344 80 mg BIW	1
Part A: M4344 160 mg BIW	1
Part A: M4344 300 mg BIW	2
Part A: M4344 450 mg BIW	4
Part A: M4344 700 mg BIW	12
Part A: M4344 1050 mg BIW	10
Part A: M4344 1200 mg BIW	7

Part A: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0) Primary · up to safety follow-up visit (Week 124.9)

Laboratory parameters: hematology and chemistry. Blood samples were collected for analysis of following hematology parameters: Hemoglobin, Erythrocytes, mean corpuscular hemoglobin (MCH), MCH concentration, Mean corpuscular volume, Reticulocytes, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes. Blood samples were collected for analysis of following chemistry parameters: Glucose, Blood urea nitrogen/Urea, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Inorganic phosphate, Total bilirubin, Direct bilirubin, Total protein, Albumin, Cre

Hematology

Group	Value	95% CI
Part A: M4344 10 mg BIW	0
Part A: M4344 20 mg BIW	0
Part A: M4344 40 mg BIW	0
Part A: M4344 80 mg BIW	0
Part A: M4344 160 mg BIW	0
Part A: M4344 300 mg BIW	0
Part A: M4344 450 mg BIW	0
Part A: M4344 700 mg BIW	0
Part A: M4344 1050 mg BIW	0
Part A: M4344 1200 mg BIW	0

Total Bilirubin

Group	Value	95% CI
Part A: M4344 10 mg BIW	0
Part A: M4344 20 mg BIW	0
Part A: M4344 40 mg BIW	0
Part A: M4344 80 mg BIW	0
Part A: M4344 160 mg BIW	0
Part A: M4344 300 mg BIW	0
Part A: M4344 450 mg BIW	0
Part A: M4344 700 mg BIW	5
Part A: M4344 1050 mg BIW	6
Part A: M4344 1200 mg BIW	4

Part A: Number of Participants With Clinically Relevant Findings in Vital Signs Primary · up to safety follow-up visit (Week 124.9)

Vital signs included body temperature, heart rate, systolic and diastolic blood pressure and respiration rate. Number of participants with clinically relevant findings in vital signs were reported. Clinical relevance was decided by Investigator.

Group	Value	95% CI
Part A: M4344 10 mg BIW	0
Part A: M4344 20 mg BIW	0
Part A: M4344 40 mg BIW	0
Part A: M4344 80 mg BIW	0
Part A: M4344 160 mg BIW	0
Part A: M4344 300 mg BIW	0
Part A: M4344 450 mg BIW	0
Part A: M4344 700 mg BIW	0
Part A: M4344 1050 mg BIW	0
Part A: M4344 1200 mg BIW	0

Part A: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) Primary · up to safety follow-up visit (Week 124.9)

ECG parameters included PR interval, RR interval, QT interval, QRS duration, QTc intervals (derived using Fridericia's correction method) and heart rate. A 12-lead ECG was recorded with the participant in a supine position after a rest of at least 5 minutes using an ECG machine. Clinical significance was decided by investigator. Number of participants with clinically significant abnormalities in 12-Lead ECGs were reported.

Group	Value	95% CI
Part A: M4344 10 mg BIW	0
Part A: M4344 20 mg BIW	0
Part A: M4344 40 mg BIW	0
Part A: M4344 80 mg BIW	0
Part A: M4344 160 mg BIW	0
Part A: M4344 300 mg BIW	0
Part A: M4344 450 mg BIW	0
Part A: M4344 700 mg BIW	1
Part A: M4344 1050 mg BIW	0
Part A: M4344 1200 mg BIW	1

Part A: Maximum Tolerated Dose (MTD) of M4344 Administered Twice Weekly (BIW) Primary · up to Cycle 1 (each cycle is of 21 days)

MTD as per NCI-CTCAE v4.0 is defined as highest dose for a given schedule at which there is no more than 1 dose- limiting toxicity (DLT) in 6 participants. DLT: as related/possibly drug-related: Neutropenia Grade (Gr)4 for \> 7 days duration/requiring hemopoietic growth factors; Febrile neutropenia; Infection with Gr3/4 neutropenia; Thrombocytopenia Gr3; Thrombocytopenia Gr4 for \> 7 days duration/requiring hemopoietic growth factors; Gr3/4 toxicity to organs other than bone marrow; Gr3/4 increase in bilirubin unless increase is due to inhibition of bilirubin glucuronidation; Death due to drug

Group	Value	95% CI
Part A: M4344	NA

Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Primary · up to safety follow-up visit (Week 39)

Group	Value	95% CI
Part A2: M4344 100 mg BID	7
Part A2: M4344 150 mg QD	5
Part A2: M4344 250 mg QD	7
Part A2: M4344 350 mg QD	7

Part A2: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) Primary · up to safety follow-up visit (Week 39)

Low lymphocytes

Group	Value	95% CI
Part A2: M4344 100 mg BID	1
Part A2: M4344 150 mg QD	1
Part A2: M4344 250 mg QD	2
Part A2: M4344 350 mg QD	3

Total Bilirubin

Group	Value	95% CI
Part A2: M4344 100 mg BID	3
Part A2: M4344 150 mg QD	2
Part A2: M4344 250 mg QD	3
Part A2: M4344 350 mg QD	3

Aspartate Aminotransferase

Group	Value	95% CI
Part A2: M4344 100 mg BID	2
Part A2: M4344 150 mg QD	1
Part A2: M4344 250 mg QD	0
Part A2: M4344 350 mg QD	4

Alanine Aminotransferase

Group	Value	95% CI
Part A2: M4344 100 mg BID	2
Part A2: M4344 150 mg QD	2
Part A2: M4344 250 mg QD	0
Part A2: M4344 350 mg QD	3

Part A2: Number of Participants With Clinically Relevant Findings in Vital Signs Primary · up to safety follow-up visit (Week 39)

Vital signs included body temperature, heart rate, systolic and diastolic blood pressure and respiration rate. Number of participants with clinically relevant findings were reported. Clinical relevance was decided by Investigator.

Group	Value	95% CI
Part A2: M4344 100 mg BID	0
Part A2: M4344 150 mg QD	0
Part A2: M4344 250 mg QD	0
Part A2: M4344 350 mg QD	0

Part A2: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) Primary · up to safety follow-up visit (Week 39)

ECG parameters included PR interval, RR interval, QT interval, QRS duration, QTc intervals (derived using Fridericia's correction method) and heart rate. A 12-lead ECG was recorded with the participant in a supine position after a rest of at least 5 minutes using an ECG machine. Clinical Significance was determined by investigator. Number of participants with clinically significant abnormalities in 12-lead ECGs were reported.

Group	Value	95% CI
Part A2: M4344 100 mg BID	0
Part A2: M4344 150 mg QD	0
Part A2: M4344 250 mg QD	0
Part A2: M4344 350 mg QD	0

Part A2: Maximum Tolerated Dose (MTD) of M4344 Administered With a Dose Dense Schedule Primary · up to Cycle 1 (each cycle is of 21 days)

MTD as per NCI-CTCAE v5.0 is defined as highest dose for a given schedule at which there is no more than 1 dose- limiting toxicity (DLT) in 6 participants. DLT: as related/possibly drug-related: Neutropenia Grade (Gr)4 for \> 7 days duration/requiring hemopoietic growth factors; Febrile neutropenia; Infection with Gr3/4 neutropenia; Thrombocytopenia Gr3; Thrombocytopenia Gr4 for \> 7 days duration/requiring hemopoietic growth factors; Gr3/4 toxicity to organs other than bone marrow; Gr3/4 increase in bilirubin unless increase is due to inhibition of bilirubin glucuronidation; Death due to drug

Group	Value	95% CI
Part A2: M4344	250

Part B1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Primary · up to Safety follow-up (Week 92.3)

Group	Value	95% CI
Part B1: M4344 350 mg + Carboplatin	3
Part B1: M4344 400 mg + Carboplatin	7
Part B1: M4344 500 mg + Carboplatin	6

Part B1: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0) Primary · up to Safety follow-up (Week 92.3)

Neutrophils

Group	Value	95% CI
Part B1: M4344 350 mg + Carboplatin	1
Part B1: M4344 400 mg + Carboplatin	1
Part B1: M4344 500 mg + Carboplatin	5

Platelets

Group	Value	95% CI
Part B1: M4344 350 mg + Carboplatin	1
Part B1: M4344 400 mg + Carboplatin	3
Part B1: M4344 500 mg + Carboplatin	3

Low hemoglobin

Group	Value	95% CI
Part B1: M4344 350 mg + Carboplatin	1
Part B1: M4344 400 mg + Carboplatin	4
Part B1: M4344 500 mg + Carboplatin	1

Low Leukocytes

Group	Value	95% CI
Part B1: M4344 350 mg + Carboplatin	0
Part B1: M4344 400 mg + Carboplatin	1
Part B1: M4344 500 mg + Carboplatin	4

Low lymphocytes

Group	Value	95% CI
Part B1: M4344 350 mg + Carboplatin	1
Part B1: M4344 400 mg + Carboplatin	3
Part B1: M4344 500 mg + Carboplatin	1

Chemistry

Group	Value	95% CI
Part B1: M4344 350 mg + Carboplatin	0
Part B1: M4344 400 mg + Carboplatin	0
Part B1: M4344 500 mg + Carboplatin	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: M4344 10 mg BIW

Serious: 1/2 (50%)

Deaths: 0/2

Part A: M4344 20 mg BIW

Serious: 0/1 (0%)

Deaths: 0/1

Part A: M4344 40 mg BIW

Serious: 1/2 (50%)

Deaths: 1/2

Part A: M4344 80 mg BIW

Serious: 0/1 (0%)

Deaths: 0/1

Part A: M4344 160 mg BIW

Serious: 1/1 (100%)

Deaths: 1/1

Part A: M4344 300 mg BIW

Serious: 0/2 (0%)

Deaths: 1/2

Part A: M4344 450 mg BIW

Serious: 2/4 (50%)

Deaths: 1/4

Part A: M4344 700 mg BIW

Serious: 6/12 (50%)

Deaths: 8/12

Part A: M4344 1050 mg BIW

Serious: 6/10 (60%)

Deaths: 3/10

Part A: M4344 1200 mg BIW

Serious: 4/7 (57%)

Deaths: 1/7

Part A2: M4344 100 mg BID

Serious: 5/7 (71%)

Deaths: 5/7

Part A2: M4344 150 mg QD

Serious: 1/5 (20%)

Deaths: 3/5

Part A2: M4344 250 mg QD

Serious: 2/7 (29%)

Deaths: 2/7

Part A2: M4344 350 mg QD

Serious: 5/7 (71%)

Deaths: 3/7

Part B1: M4344 350 mg + Carboplatin

Serious: 1/3 (33%)

Deaths: 1/3

Part B1: M4344 400 mg + Carboplatin

Serious: 4/7 (57%)

Deaths: 4/7

Part B1: M4344 500 mg + Carboplatin

Serious: 3/6 (50%)

Deaths: 2/6

Part C: M4344 250 mg QD

Serious: 7/13 (54%)

Deaths: 6/13

Serious adverse events (52 terms)

Reaction	System	Part A: M4344 10 mg BIW	Part A: M4344 20 mg BIW	Part A: M4344 40 mg BIW	Part A: M4344 80 mg BIW	Part A: M4344 160 mg BIW	Part A: M4344 300 mg BIW	Part A: M4344 450 mg BIW	Part A: M4344 700 mg BIW	Part A: M4344 1050 mg BIW	Part A: M4344 1200 mg BIW	Part A2: M4344 100 mg BID	Part A2: M4344 150 mg QD	Part A2: M4344 250 mg QD	Part A2: M4344 350 mg QD	Part B1: M4344 350 mg + Ca…	Part B1: M4344 400 mg + Ca…	Part B1: M4344 500 mg + Ca…	Part C: M4344 250 mg QD
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Disease progression	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypersensitivity	Immune system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cauda equina syndrome	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (163 terms — click to expand)

Reaction	System	Part A: M4344 10 mg BIW	Part A: M4344 20 mg BIW	Part A: M4344 40 mg BIW	Part A: M4344 80 mg BIW	Part A: M4344 160 mg BIW	Part A: M4344 300 mg BIW	Part A: M4344 450 mg BIW	Part A: M4344 700 mg BIW	Part A: M4344 1050 mg BIW	Part A: M4344 1200 mg BIW	Part A2: M4344 100 mg BID	Part A2: M4344 150 mg QD	Part A2: M4344 250 mg QD	Part A2: M4344 350 mg QD	Part B1: M4344 350 mg + Ca…	Part B1: M4344 400 mg + Ca…	Part B1: M4344 500 mg + Ca…	Part C: M4344 250 mg QD
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Jaundice	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ocular hyperaemia	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Blood bilirubin increased, Disease progression, Pyrexia, Diarrhoea, Neutropenia, Abdominal pain, Nausea, Upper gastrointestinal haemorrhage.

Data from ClinicalTrials.gov NCT02278250 adverse events section.

Sponsor's own description

The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 alone and in combination with carboplatin to determine the safety and maximum tolerated dose.

Publications & conference data

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

State-of-the-art strategies for targeting the DNA damage response in cancer.
Pilié PG, Tang C, Mills GB, Yap TA. · · 2019 · cited 876× · PMID 30356138 · DOI 10.1038/s41571-018-0114-z
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
Drug repurposing for cancer therapy.
Xia Y, Sun M, Huang H, Jin WL. · · 2024 · cited 229× · PMID 38637540 · DOI 10.1038/s41392-024-01808-1
Advances in synthetic lethality for cancer therapy: cellular mechanism and clinical translation.
Topatana W, Juengpanich S, Li S, Cao J, et al · · 2020 · cited 128× · PMID 32883316 · DOI 10.1186/s13045-020-00956-5
Ataxia telangiectasia and Rad3-related inhibitors and cancer therapy: where we stand.
Mei L, Zhang J, He K, Zhang J. · · 2019 · cited 104× · PMID 31018854 · DOI 10.1186/s13045-019-0733-6
Progress towards a clinically-successful ATR inhibitor for cancer therapy.
Barnieh FM, Loadman PM, Falconer RA. · · 2021 · cited 97× · PMID 34909652 · DOI 10.1016/j.crphar.2021.100017
Novel and Highly Potent ATR Inhibitor M4344 Kills Cancer Cells With Replication Stress, and Enhances the Chemotherapeutic Activity of Widely Used DNA Damaging Agents.
Jo U, Senatorov IS, Zimmermann A, Saha LK, et al · · 2021 · cited 83× · PMID 34045232 · DOI 10.1158/1535-7163.mct-20-1026
Development of synthetic lethality in cancer: molecular and cellular classification.
Li S, Topatana W, Juengpanich S, Cao J, et al · · 2020 · cited 82× · PMID 33077733 · DOI 10.1038/s41392-020-00358-6

Verify or expand the search:

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

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NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
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Other EMD Serono Research & Development Institute, Inc. trials

Trials by the same sponsor.

NCT07355218 — A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2) · Phase 3 · recruiting
NCT07332481 — A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease · Phase 3 · recruiting
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
NCT07097259 — A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy · Phase 1 · completed

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 NCT02278250 (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: 16 March 2023

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/NCT02278250.

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