Who is sponsoring NCT04424641?

NCT04424641 is sponsored by Genmab.

What condition does NCT04424641 study?

NCT04424641 studies Locally Advanced or Metastatic Solid Tumor(s), Prostate Cancer, Esophageal Cancer, Triple Negative Breast Cancer (TNBC), Squamous Cell Carcinoma of Head and Neck (SCCHN), Non-small Cell Lung Cancer (NSCLC), Bladder Cancer, Uterine Cancer.

Is NCT04424641 still recruiting?

NCT04424641 is currently terminated. Last updated 25 July 2023.

Are results published for NCT04424641?

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

Last reviewed 2023-07-25 · How we verify

NCT04424641

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

A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors

Terminated Phase 1, PHASE2 Results posted Last updated 25 July 2023

What this trial tests

Phase 1, PHASE2 trial testing GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4. in Locally Advanced or Metastatic Solid Tumor(s) in 48 participants. Terminated before completion.

Timeline

15 July 2020

Primary endpoint
29 October 2021

29 October 2021

Quick facts

Lead sponsor	Genmab
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	15 July 2020
Primary completion	29 October 2021
Estimated completion	29 October 2021
Sites	6 locations across Denmark, United States, Israel, Spain

Drugs / interventions tested

GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4. — full drug profile →

Conditions studied

Locally Advanced or Metastatic Solid Tumor(s) — all drugs for Locally Advanced or Metastatic Solid Tumor(s) →
Prostate Cancer — all drugs for Prostate Cancer →
Esophageal Cancer — all drugs for Esophageal Cancer →
Triple Negative Breast Cancer (TNBC) — all drugs for Triple Negative Breast Cancer (TNBC) →

Sponsor

Genmab — full company profile →

Who can join

18 and older, any sex, with Locally Advanced or Metastatic Solid Tumor(s) or Prostate Cancer. 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 With Dose Limiting Toxicities (DLTs) Primary · From Day 1 to Day 21 of first cycle

The DLT was defined as Grade (G) \>= 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome; any G3 or 4 hematologic and non-hematologic toxicity (with exceptions defined by the protocol); laboratory abnormality that required clinically significant medical intervention, led to hospitalization, persisted for \>1 week, or resulted in a drug-induced liver injury; G3 or 4 febrile neutropenia; liver toxicity defined by Hy's law; any treatment-related toxicity that caused treatment discontinuation during Cycle 1; or any G5 toxicity.

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	0
GEN1044 Doses 1/3/30 mg	0
GEN1044 Doses 1/5/30 mg	0
GEN1044 Doses 1/10/30 mg	1
GEN1044 Doses 1/5/45 mg	3
GEN1044 Doses 1/3/60 mg	3

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Primary · Day 1 through Day 263 (corresponding to maximum observed duration)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \[medical and scientific judgment must be exercised in deciding

Any TEAE

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	1
GEN1044 Doses 1/3/10 mg	4
GEN1044 Doses 1/3/30 mg	7
GEN1044 Doses 1/5/30 mg	7
GEN1044 Doses 1/10/30 mg	6
GEN1044 Doses 1/5/37.5 mg	2
GEN1044 Doses 1/5/45 mg	4
GEN1044 Doses 1/3/60 mg	6

Any TESAE

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	1
GEN1044 Doses 1/3/10 mg	1
GEN1044 Doses 1/3/30 mg	3
GEN1044 Doses 1/5/30 mg	5
GEN1044 Doses 1/10/30 mg	4
GEN1044 Doses 1/5/37.5 mg	1
GEN1044 Doses 1/5/45 mg	3
GEN1044 Doses 1/3/60 mg	5

Number of Participants With Abnormal Laboratory Values Primary · Day 1 through Day 263 (corresponding to maximum observed duration)

Number of participants with laboratory values of Grade \>= 3 by NCI-CTCAE v5.0 are reported. The NCI-CTCAE is a descriptive terminology that is used for gradings (Grade 1-5) of Adverse Events (AEs) and of laboratory values; the latter being summarized here. This table reports laboratory values graded only on the numerical value of the reported parameter and is therefore not graded by symptoms or signs. The abnormal laboratory values assessed by the investigator as being AEs are reported also in the AE table. In case a participant reported multiple severity grades for a laboratory value, only

Lymphocyte count decreased

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	1
GEN1044 Doses 1/3/10 mg	4
GEN1044 Doses 1/3/30 mg	7
GEN1044 Doses 1/5/30 mg	4
GEN1044 Doses 1/10/30 mg	5
GEN1044 Doses 1/5/37.5 mg	2
GEN1044 Doses 1/5/45 mg	2
GEN1044 Doses 1/3/60 mg	6

Lipase increased

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	0
GEN1044 Doses 1/3/30 mg	1
GEN1044 Doses 1/5/30 mg	1
GEN1044 Doses 1/10/30 mg	0
GEN1044 Doses 1/5/37.5 mg	1
GEN1044 Doses 1/5/45 mg	2
GEN1044 Doses 1/3/60 mg	2

Serum amylase increased

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	0
GEN1044 Doses 1/3/30 mg	1
GEN1044 Doses 1/5/30 mg	1
GEN1044 Doses 1/10/30 mg	1
GEN1044 Doses 1/5/37.5 mg	1
GEN1044 Doses 1/5/45 mg	1
GEN1044 Doses 1/3/60 mg	1

Hypomagnesemia

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	0
GEN1044 Doses 1/3/30 mg	0
GEN1044 Doses 1/5/30 mg	0
GEN1044 Doses 1/10/30 mg	1
GEN1044 Doses 1/5/37.5 mg	0
GEN1044 Doses 1/5/45 mg	2
GEN1044 Doses 1/3/60 mg	0

Creatinine increased

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	0
GEN1044 Doses 1/3/30 mg	0
GEN1044 Doses 1/5/30 mg	1
GEN1044 Doses 1/10/30 mg	0
GEN1044 Doses 1/5/37.5 mg	0
GEN1044 Doses 1/5/45 mg	1
GEN1044 Doses 1/3/60 mg	0

Anemia

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	1
GEN1044 Doses 1/3/30 mg	0
GEN1044 Doses 1/5/30 mg	0
GEN1044 Doses 1/10/30 mg	0
GEN1044 Doses 1/5/37.5 mg	0
GEN1044 Doses 1/5/45 mg	0
GEN1044 Doses 1/3/60 mg	1

Hypokalemia

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	1
GEN1044 Doses 1/3/30 mg	0
GEN1044 Doses 1/5/30 mg	0
GEN1044 Doses 1/10/30 mg	0
GEN1044 Doses 1/5/37.5 mg	0
GEN1044 Doses 1/5/45 mg	1
GEN1044 Doses 1/3/60 mg	0

Hypoalbuminemia

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	0
GEN1044 Doses 1/3/30 mg	0
GEN1044 Doses 1/5/30 mg	0
GEN1044 Doses 1/10/30 mg	1
GEN1044 Doses 1/5/37.5 mg	0
GEN1044 Doses 1/5/45 mg	0
GEN1044 Doses 1/3/60 mg	0

Number of Participants With Complete Response (CR) or Partial Response (PR) Secondary · Day 1 through Day 233

The radiological evaluation based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) was performed by investigator using computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan/ positron emission tomography (PET) scan. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to \< 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of longest diameters.

Complete response

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	0
GEN1044 Doses 1/3/30 mg	0
GEN1044 Doses 1/5/30 mg	0
GEN1044 Doses 1/10/30 mg	0
GEN1044 Doses 1/5/37.5 mg	0
GEN1044 Doses 1/5/45 mg	0
GEN1044 Doses 1/3/60 mg	0

Partial response

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	0
GEN1044 Doses 1/3/30 mg	0
GEN1044 Doses 1/5/30 mg	0
GEN1044 Doses 1/10/30 mg	0
GEN1044 Doses 1/5/37.5 mg	0
GEN1044 Doses 1/5/45 mg	0
GEN1044 Doses 1/3/60 mg	1

Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1044 Secondary · Day 1 through Day 263 (predose on Day 1 of Cycles 1, 2, 3, 5, 7, and then on Day 1 of every 4 cycles thereafter, end of treatment [EOT], and 30 days after last study drug)

The detection and titer characterization of ADAs was performed using validated, specific, and sensitive electrochemiluminescence immunoassay (ECLIA) methods. Number of participants with ADA positive post baseline to GEN1044 are reported.

Group	Value	95% CI
GEN1044 Doses 0.3/3/3 mg	0
GEN1044 Doses 1/3/10 mg	3
GEN1044 Doses 1/3/30 mg	2
GEN1044 Doses 1/5/30 mg	1
GEN1044 Doses 1/10/30 mg	0
GEN1044 Doses 1/5/37.5 mg	0
GEN1044 Doses 1/5/45 mg	1
GEN1044 Doses 1/3/60 mg	1

Adverse events — posted to ClinicalTrials.gov

Time frame: For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GEN1044 Doses 0.3/3/3 mg

Serious: 1/1 (100%)

Deaths: 1/1

GEN1044 Doses 1/3/10 mg

Serious: 1/4 (25%)

Deaths: 2/4

GEN1044 Doses 1/3/30 mg

Serious: 3/7 (43%)

Deaths: 3/7

GEN1044 Doses 1/5/30 mg

Serious: 5/7 (71%)

Deaths: 0/7

GEN1044 Doses 1/10/30 mg

Serious: 4/6 (67%)

Deaths: 4/6

GEN1044 Doses 1/5/37.5 mg

Serious: 1/2 (50%)

Deaths: 0/2

GEN1044 Doses 1/5/45 mg

Serious: 3/4 (75%)

Deaths: 1/4

GEN1044 Doses 1/3/60 mg

Serious: 5/6 (83%)

Deaths: 2/6

Serious adverse events (18 terms)

Reaction	System	GEN1044 Doses 0.3/3/3 mg	GEN1044 Doses 1/3/10 mg	GEN1044 Doses 1/3/30 mg	GEN1044 Doses 1/5/30 mg	GEN1044 Doses 1/10/30 mg	GEN1044 Doses 1/5/37.5 mg	GEN1044 Doses 1/5/45 mg	GEN1044 Doses 1/3/60 mg
Cytokine Release Syndrome	Immune system disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Atrial Fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—
Atrial Flutter	Cardiac disorders	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
General Physical Health Deterioration	General disorders	—	—	—	—	—	—	—	—
Platelet Count Decreased	Investigations	—	—	—	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Tumour Associated Fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—
Acute Kidney Injury	Renal and urinary disorders	—	—	—	—	—	—	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Dermatitis Exfoliative Generalised	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—

Other adverse events (89 terms — click to expand)

Reaction	System	GEN1044 Doses 0.3/3/3 mg	GEN1044 Doses 1/3/10 mg	GEN1044 Doses 1/3/30 mg	GEN1044 Doses 1/5/30 mg	GEN1044 Doses 1/10/30 mg	GEN1044 Doses 1/5/37.5 mg	GEN1044 Doses 1/5/45 mg	GEN1044 Doses 1/3/60 mg
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Decreased Appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Oedema Peripheral	General disorders	—	—	—	—	—	—	—	—
Cytokine Release Syndrome	Immune system disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dry Mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—
Infusion Related Reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Rash Maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—
Non-cardiac Chest Pain	General disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Flushing	Vascular disorders	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Vision Blurred	Eye disorders	—	—	—	—	—	—	—	—
Abdominal Distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
General Physical Health Deterioration	General disorders	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—
Ulcer	General disorders	—	—	—	—	—	—	—	—
Candida Infection	Infections and infestations	—	—	—	—	—	—	—	—
Clostridium Difficile Infection	Infections and infestations	—	—	—	—	—	—	—	—
Nail Infection	Infections and infestations	—	—	—	—	—	—	—	—
Skin Infection	Infections and infestations	—	—	—	—	—	—	—	—

Most-reported serious reactions: Cytokine Release Syndrome, Diarrhoea, Pneumonitis, Atrial Fibrillation, Atrial Flutter, Vertigo, Abdominal Pain, Vomiting.

Data from ClinicalTrials.gov NCT04424641 adverse events section.

Sponsor's own description

The purpose of the trial is to evaluate the safety, determine the recommended Phase 2 dose (RP2D), and assess preliminary clinical activity of GEN1044 in patients with solid tumors.

Publications & conference data

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

Advances in immunotherapy for triple-negative breast cancer.
Liu Y, Hu Y, Xue J, Li J, et al · · 2023 · cited 198× · PMID 37660039 · DOI 10.1186/s12943-023-01850-7
The landscape of bispecific T cell engager in cancer treatment.
Zhou S, Liu M, Ren F, Meng X, et al · · 2021 · cited 172× · PMID 34039409 · DOI 10.1186/s40364-021-00294-9
Overcoming Challenges for CD3-Bispecific Antibody Therapy in Solid Tumors.
Middelburg J, Kemper K, Engelberts P, Labrijn AF, et al · · 2021 · cited 122× · PMID 33466732 · DOI 10.3390/cancers13020287
Overcoming the challenges associated with CD3+ T-cell redirection in cancer.
Singh A, Dees S, Grewal IS. · · 2021 · cited 82× · PMID 33469153 · DOI 10.1038/s41416-020-01225-5
Bispecific antibodies in cancer therapy: Target selection and regulatory requirements.
Sun Y, Yu X, Wang X, Yuan K, et al · · 2023 · cited 62× · PMID 37719370 · DOI 10.1016/j.apsb.2023.05.023
Novel Redirected T-Cell Immunotherapies for Advanced Prostate Cancer.
Dorff TB, Narayan V, Forman SJ, Zang PD, et al · · 2022 · cited 43× · PMID 34675084 · DOI 10.1158/1078-0432.ccr-21-1483
Immune cell engagers in solid tumors: promises and challenges of the next generation immunotherapy.
Fucà G, Spagnoletti A, Ambrosini M, de Braud F, et al · · 2021 · cited 41× · PMID 33508733 · DOI 10.1016/j.esmoop.2020.100046
Bispecific Antibodies: A Smart Arsenal for Cancer Immunotherapies.
You G, Won J, Lee Y, Moon D, et al · · 2021 · cited 39× · PMID 34358141 · DOI 10.3390/vaccines9070724

Verify or expand the search:

Other Genmab trials

Trials by the same sponsor.

NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07288177 — Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer · Phase 2 · recruiting
NCT06984328 — Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin · Phase 2 · active not recruiting
NCT06771921 — A First-in-Human Trial of Safety and Efficacy of GEN1078 in Participants With Solid Tumors · Phase 1, PHASE2 · terminated

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 NCT04424641 (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 Genmab
Last refreshed: 25 July 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/NCT04424641.

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