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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003998-26 | EudraCT Number | ||
| MOH_2020-07-26_008713 | Registry Identifier | Clinical Research Site - mytrial |
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Study was terminated due to MTD was reached
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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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.
The trial is an open-label, multi-center safety trial of GEN1044. The trial consists of two parts: a dose-escalation part (Phase 1) and an expansion part (Phase 2a). The expansion part of the trial will be initiated once the RP2D has been determined from Phase 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEN1044 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4. | Biological | GEN1044 will be administered intravenously in cycles of 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | 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. | From Day 1 to Day 21 of first cycle |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 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 whether an AE is 'medically significant']); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening between the first dose of GEN1044 and 30 days after the last dose received. | Day 1 through Day 263 (corresponding to maximum observed duration) |
| Number of Participants With Abnormal Laboratory Values | 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 the maximum grade was used. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response (CR) or Partial Response (PR) | 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. |
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Key Inclusion Criteria:
Dose-escalation part:
• Patient with locally advanced or metastatic solid tumor(s) (excluding patients with primary central nervous system [CNS] tumors), who has experienced disease progression while on standard therapy or is intolerant of, or not eligible for, standard therapy.
Expansion part:
• Must have an advanced or metastatic, pathologically confirmed diagnosis of one of the following tumors: Uterine Cancer, Prostate Cancer, Esophageal Cancer, TNBC, SCCHN, NSCLC (both adenocarcinoma [ACC] and squamous cell carcinoma [SCC], Bladder Cancer.
Both parts:
Key Exclusion Criteria (both parts):
Has an uncontrolled intercurrent illness, including but not limited to:
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new or symptomatic brain metastases or stroke.
Prior therapy:
Radiotherapy: Radiotherapy within 14 days prior to first GEN1044 administration. Palliative radiotherapy will be allowed.
Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1044 administration. Toxicities from previous anti-cancer therapies that have not resolved.
Has a history of ≥ grade 2 cytokine release syndrome (CRS) with other CD3-based bispecifics, or a history of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or has known allergies, hypersensitivity, or intolerance to GEN1044 or its excipients.
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Oliveri, MD | Genmab | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennesse Oncology, PLLC - Nashville | Nashville | Tennessee | 37203 | United States | ||
| MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36271507 | Background | Kemper K, Gielen E, Boross P, Houtkamp M, Plantinga TS, de Poot SA, Burm SM, Janmaat ML, Koopman LA, van den Brink EN, Rademaker R, Verzijl D, Engelberts PJ, Satijn D, Sasser AK, Breij EC. Mechanistic and pharmacodynamic studies of DuoBody-CD3x5T4 in preclinical tumor models. Life Sci Alliance. 2022 Sep 8;5(11):e202201481. doi: 10.26508/lsa.202201481. Print 2022 Nov. |
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A total of 48 participants signed the informed consent form of whom 37 received study drug. The Safety Committee decided to stop enrollment during the dose-escalation part and therefore the expansion part of trial never started. Consequently, results are available for only the dose-escalation part.
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| ID | Title | Description |
|---|---|---|
| FG000 | GEN1044 Doses 0.3/3/3 mg | Participants with locally advanced or metastatic non-central nervous system (CNS) solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on Cycle [C] 1 Day (D] 1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by every 3 weeks (Q3W) until the end of treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2021 | Sep 21, 2022 |
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|
| Day 1 through Day 263 (corresponding to maximum observed duration) |
| Day 1 through Day 233 |
| Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1044 | 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. | 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) |
| Houston |
| Texas |
| 77054 |
| United States |
| Rigshospitalet (Copenhagen University Hospital) | Copenhagen | 2100 | Denmark |
| Chaim Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Hospital Universitari Vall d'Hebron | Barcelona | 8035 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| FG001 |
| GEN1044 Doses 1/3/10 mg |
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| FG002 | GEN1044 Doses 1/3/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| FG003 | GEN1044 Doses 1/5/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| FG004 | GEN1044 Doses 1/10/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| FG005 | GEN1044 Doses 1/5/37.5 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| FG006 | GEN1044 Doses 1/5/45 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| FG007 | GEN1044 Doses 1/3/60 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.
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| ID | Title | Description |
|---|---|---|
| BG000 | GEN1044 Doses 0.3/3/3 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| BG001 | GEN1044 Doses 1/3/10 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| BG002 | GEN1044 Doses 1/3/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| BG003 | GEN1044 Doses 1/5/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| BG004 | GEN1044 Doses 1/10/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| BG005 | GEN1044 Doses 1/5/37.5 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| BG006 | GEN1044 Doses 1/5/45 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| BG007 | GEN1044 Doses 1/3/60 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | 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. | Dose-determining set (DDS) included all participants who received at least 1 dose of study drug during the dose-escalation part, and who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT during the first 21 days of dosing. | Posted | Count of Participants | Participants | From Day 1 to Day 21 of first cycle |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 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 whether an AE is 'medically significant']); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening between the first dose of GEN1044 and 30 days after the last dose received. | Safety set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort. | Posted | Count of Participants | Participants | Day 1 through Day 263 (corresponding to maximum observed duration) |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Laboratory Values | 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 the maximum grade was used. | Safety set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort. | Posted | Count of Participants | Participants | Day 1 through Day 263 (corresponding to maximum observed duration) |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Complete Response (CR) or Partial Response (PR) | 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. | Full analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort. | Posted | Count of Participants | Participants | Day 1 through Day 233 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1044 | 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. | Immunogenicity analysis set included all participants who received at least 1 dose of study drug and had evaluable immunogenicity samples. | Posted | Count of Participants | Participants | 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) |
|
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)
The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GEN1044 Doses 0.3/3/3 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. | 1 | 1 | 1 | 1 | 1 | 1 |
| EG001 | GEN1044 Doses 1/3/10 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. | 2 | 4 | 1 | 4 | 4 | 4 |
| EG002 | GEN1044 Doses 1/3/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. | 3 | 7 | 3 | 7 | 7 | 7 |
| EG003 | GEN1044 Doses 1/5/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. | 0 | 7 | 5 | 7 | 7 | 7 |
| EG004 | GEN1044 Doses 1/10/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. | 4 | 6 | 4 | 6 | 6 | 6 |
| EG005 | GEN1044 Doses 1/5/37.5 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG006 | GEN1044 Doses 1/5/45 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. | 1 | 4 | 3 | 4 | 4 | 4 |
| EG007 | GEN1044 Doses 1/3/60 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. | 2 | 6 | 5 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Tumour Associated Fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v24.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Dermatitis Exfoliative Generalised | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (v24.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Non-cardiac Chest Pain | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Candida Infection | Infections and infestations | MedDRA (v24.1) | Systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDRA (v24.1) | Systematic Assessment |
| |
| Nail Infection | Infections and infestations | MedDRA (v24.1) | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA (v24.1) | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA (v24.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (v24.1) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Amylase Increased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Blood Creatine Increased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| C-reactive Protein Increased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Lipase Increased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (v24.1) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Tumour Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v24.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Dermatitis Exfoliative Generalised | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Palmar-plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA (v24.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (v24.1) | Systematic Assessment |
|
Upon review and evaluation of the overall safety profile and safety signals of GEN1044 during the dose-escalation part, the Safety Committee decided to stop further enrollment and the Sponsor decided to stop the compound development. Hence, the expansion part of the trial was never initiated, and while a majority of the pharmacokinetic (PK) samples from the dose-escalation part were quantified, the PK parameters were not calculated due to termination of the trial.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 12 months but less than 18 months from the end of study (database lock). The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information | Genmab | +45 7020 2728 | clinicaltrials@genmab.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2021 | Sep 21, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004938 | Esophageal Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001749 | Urinary Bladder Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D005833 | Genital Neoplasms, Female |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
Not provided
Not provided
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG002 | GEN1044 Doses 1/3/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG003 | GEN1044 Doses 1/5/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG004 | GEN1044 Doses 1/10/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG005 | GEN1044 Doses 1/5/37.5 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG006 | GEN1044 Doses 1/5/45 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG007 | GEN1044 Doses 1/3/60 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
|
|
| OG002 | GEN1044 Doses 1/3/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG003 | GEN1044 Doses 1/5/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG004 | GEN1044 Doses 1/10/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG005 | GEN1044 Doses 1/5/37.5 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG006 | GEN1044 Doses 1/5/45 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG007 | GEN1044 Doses 1/3/60 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
|
|
| OG002 | GEN1044 Doses 1/3/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG003 | GEN1044 Doses 1/5/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG004 | GEN1044 Doses 1/10/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG005 | GEN1044 Doses 1/5/37.5 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG006 | GEN1044 Doses 1/5/45 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG007 | GEN1044 Doses 1/3/60 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
|
|
Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG003 | GEN1044 Doses 1/5/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG004 | GEN1044 Doses 1/10/30 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG005 | GEN1044 Doses 1/5/37.5 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG006 | GEN1044 Doses 1/5/45 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
| OG007 | GEN1044 Doses 1/3/60 mg | Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment. |
|
|