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Due to the limited activity in Phase 1, NextCure decided to discontinue development of the anti-B7-H4 antibody monotherapy trial (NC762-01) to move forward with a prioritized B7-H4 ADC program.
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This research study is studying a new drug, NC762, as a possible treatment for advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5mg/kg NC762 | Experimental | Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
|
| 1.5mg/kg NC762 | Experimental | Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
|
| 5mg/kg NC762 | Experimental | Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
|
| 10mg/kg NC762 | Experimental | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
|
| 20mg/kg NC762 | Experimental | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NC762 | Drug | NC762 is an experimental antibody drug that may make the immune response more active against cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 | Frequency, duration, and severity of treatment-emergent adverse events (AEs) | From enrollment through up to 90 days after end of treatment, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
Inability to comprehend or unwilling to sign the ICF.
Laboratory and medical history parameters not within the protocol-defined range.
Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 7 days before the first administration of study drug.
Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy and radiation therapy) and/or complications from prior surgical intervention before starting therapy.
Receipt of a live vaccine within 30 days of planned start of study therapy.
Active autoimmune disease that required systemic treatment in the past (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
Known active CNS metastases and/or carcinomatous meningitis.
Known concurrent malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
Documented known activating or driver mutations (i.e. EGFR mutations/amplification, BRAF mutations, ALK alterations, etc.) which have not been previously treated with a standard of care targeted therapy.
Subjects with screening QTc interval > 470 milliseconds (corrected by Fridericia) are excluded.
Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti-infection treatment.
Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured.
Known history of HIV (HIV 1 or HIV 2 antibodies).
Known allergy or reaction to any component of study drug or formulation components.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study treatment.
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
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| Name | Affiliation | Role |
|---|---|---|
| Han Myint, MD | NextCure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06519 | United States | ||
| The University of Chicago Medicine and Biological Sciences |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5mg/kg NC762 | Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| FG001 | 1.5mg/kg NC762 |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2021 |
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Phase 1 will utilize a 3 + 3 design to explore escalating dose levels. Phase 2 Dose Expansion will further evaluate the safety, tolerability, preliminary efficacy, and PK/PD activity of NC762 at the RP2D utilizing a Simon 2-stage design.
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| Approximately 1 year |
| Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. | Approximately 1 year |
| Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Approximately 1 year |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | To evaluate progression-free survival (PFS), defined as the time from the first dose of NC762 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Approximately 1 year |
| Overall Survival (OS) | To evaluate overall survival (OS), defined as the time from the first dose of NC762 to death due to any cause. | Approximately 1 year |
| Maximum Serum Concentration (Cmax) of NC762 | To evaluate the Maximum Serum Concentration (Cmax) of NC762 | Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days. |
| Area Under the Curve (AUC) of NC762 | To evaluate the Area Under the Curve (AUC) of NC762 | Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days. |
| Half-life (T1/2) of NC762 | To evaluate the Half-life (T1/2) of NC762 | Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days. |
| Chicago |
| Illinois |
| 60637 |
| United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | United States |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | United States |
Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| FG002 | 5mg/kg NC762 | Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| FG003 | 10mg/kg NC762 | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| FG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5mg/kg NC762 | Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| BG001 | 1.5mg/kg NC762 | Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| BG002 | 5mg/kg NC762 | Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| BG003 | 10mg/kg NC762 | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| BG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| BG005 | 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 |
| |||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Body Mass Index (BMI) | One participant in 10mg/kg cohort did not have baseline height collected, therefore baseline BMI could not be calculated. | Mean | Standard Deviation | kg/m2 |
|
| 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 Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 | Frequency, duration, and severity of treatment-emergent adverse events (AEs) | The Safety Analysis Set (SAS) will include all the subjects who receive any amount of study drug. | Posted | Count of Participants | Participants | From enrollment through up to 90 days after end of treatment, an average of 1 year |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC762 | Posted | Count of Participants | Participants | Approximately 1 year |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. | The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC762 | Posted | Median | 99% Confidence Interval | months | Approximately 1 year |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | The FAS includes all subjects enrolled in the study who received at least one full dose of NC762 | Posted | Count of Participants | Participants | Approximately 1 year |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | To evaluate progression-free survival (PFS), defined as the time from the first dose of NC762 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The FAS includes all subjects enrolled in the study who received at least one full dose of NC762 | Posted | Median | 95% Confidence Interval | weeks | Approximately 1 year |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | To evaluate overall survival (OS), defined as the time from the first dose of NC762 to death due to any cause. | The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC762 | Posted | Median | 95% Confidence Interval | months | Approximately 1 year |
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| Secondary | Maximum Serum Concentration (Cmax) of NC762 | To evaluate the Maximum Serum Concentration (Cmax) of NC762 | The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. | Posted | Mean | Standard Deviation | ug/mL | Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days. |
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| Secondary | Area Under the Curve (AUC) of NC762 | To evaluate the Area Under the Curve (AUC) of NC762 | The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. AUC from time 0 to the last measurable concentration. | Posted | Mean | Standard Deviation | h*ug/mL | Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days. |
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| Secondary | Half-life (T1/2) of NC762 | To evaluate the Half-life (T1/2) of NC762 | The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. Half-Life Lambda z (h). | Posted | Mean | Standard Deviation | h | Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days. |
|
From enrollment through up to 90 days after end of treatment, an average of 1 year.
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
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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 | 0.5mg/kg NC762 | Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer | 1 | 4 | 0 | 4 | 4 | 4 |
| EG001 | 1.5mg/kg NC762 | Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer | 1 | 4 | 0 | 4 | 3 | 4 |
| EG002 | 5mg/kg NC762 | Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer | 2 | 3 | 1 | 3 | 3 | 3 |
| EG003 | 10mg/kg NC762 | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer | 2 | 11 | 1 | 11 | 11 | 11 |
| EG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer | 9 | 18 | 11 | 18 | 17 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Mental Status Change | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Vomitting | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Malignant Ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pancreatic mass | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Non-cardia chest pain | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Facial bone fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood folate decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Carbon dioxide increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
|
PI cannot publish study results before the first multi-center publication. If a multi-center publication is not submitted within 12 months after the end of the study at all sites, or if Sponsor confirms there will be no multi-center publication, the PI may publish study results. However, PI will allow Sponsor at least 30 days to review any publication of study results and Sponsor may request an additional 60 days to review the publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior VP, Clinical and Translational Development | NextCure, Inc | 240-399-4900 | NCClin@nextcure.com |
| Dec 19, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
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Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer
| OG003 | 10mg/kg NC762 | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| OG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
|
|
| OG002 | 5mg/kg NC762 | Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| OG003 | 10mg/kg NC762 | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| OG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
|
|
| OG003 | 10mg/kg NC762 | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| OG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
|
|
Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| OG003 | 10mg/kg NC762 | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| OG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
|
|
| OG003 | 10mg/kg NC762 | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| OG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
|
|
| OG003 | 10mg/kg NC762 | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| OG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
|
|
| OG003 | 10mg/kg NC762 | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| OG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
|
|
| OG003 |
| 10mg/kg NC762 |
Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
| OG004 | 20mg/kg NC762 | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). NC762: NC762 is an experimental antibody drug that may make the immune response more active against cancer |
|
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