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| Name | Class |
|---|---|
| Translational Drug Development | OTHER |
Not provided
Not provided
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Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP), following Obinutuzumab Pretreatment, on Days -13 and -12. NAP will be administered on Days 1-4 of treatment cycles 1-6, followed by docetaxel on Day 5. Starting cycle 7, NAP at a higher dose will be administered on Day 1 only and docetaxel on Day 2, in 21 days treatment cycles. When NAP is administered as monotherapy and not earlier than cycle 7, NAP will be administered on Day 1 only and cycles will be of 28 days treatment cycle.
Patients must have received at least 1 and no more than 2 prior systemic regimens for the treatment of advanced/metastatic NSCLC. Patients were required to have progressed following treatment with both platinum-based chemotherapy and an anti-PD-(L)1 antibody administered either sequentially or concurrently. Entry into this trial was restricted to patients with incurable disease, including those whose disease had relapsed within 6 months after chemoradiotherapy for Stage III disease. Patients were to have available archival or fresh tissue collected for the retrospective determination of tumoral 5T4 levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAP in combination with docetaxel following obinutuzumab pretreatment | Experimental | Subjects receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP is administered by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel on Day 5. Treatment cycles with the combination NAP/docetaxel are of 21 days in duration. Starting cycle 7, NAP at a higher dose is administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles are of 28 days of duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAP (Naptumomab estafenatox) | Drug | Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that are linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP is administered at a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg is administered on Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and iRECIST for target lesions and assessed by CT scans 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; Overall Response (OR) = CR + PR | From the first treatment to first CR or PR (estimated about 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | The proportion of subjects who achieve a best response of CR, PR or SD per Response Evaluation in Solid Tumors (iRECIST). | From the first administration of treatment till study completion (estimated about 24 months). |
| Duration of Response (DOR) |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Subjects with active infection requiring treatment within 3 days of C1D1.
Subjects with other active neoplastic disease requiring concurrent anti-neoplastic treatment
Subjects with known, suspected or documented parenchymal brain metastases unless treated with surgery and/or radiation, with the subject neurologically stable and off pharmacologic doses of systemic glucocorticoids; subjects with leptomeningeal metastases are not eligible. Patients should have completed brain radiation for at least 14 days and be off steroids.
Active or previously documented autoimmune or inflammatory disorders such as, but not limited to rheumatoid arthritis, systemic lupus erythematosus, uveitis, ulcerative colitis, Crohn's syndrome, Wegener's syndrome, multiple sclerosis, myasthenia gravis, scleroderma and sarcoidosis. The following are exceptions to this criterion:
History of primary immunodeficiency
Subjects with a history or prior allogeneic organ transplant
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Ilana Lorber, MD | NeoTX Therapeutics Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeoTX - 10307 | Daphne | Alabama | 36526 | United States | ||
| NeoTX - 10302 |
Not provided
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment | Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration. NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1. Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2. Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Dec 25, 2022 |
Not provided
Not provided
Subjects receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP is administered by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel on Day 5. Treatment cycles with the combination NAP/docetaxel are of 21 days in duration. Starting cycle 7, NAP at a higher dose is administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles are of 28 days of duration.
Not provided
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|
|
| Docetaxel | Drug | Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel is administered in combination with the study drug, NAP, on Day 2. |
|
|
| Obinutuzumab | Drug | Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle. |
|
|
Duration from first documentation of CR or PR (whichever occurs first) after the first administration of obinutuzumab pretreatment until death or progressive disease (PD) |
| estimated about 24 months. |
| Progression-free Survival (PFS) | PFS per Response Evaluation in Solid Tumors (iRECIST) | From the first administration of treatment to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (estimated about 24 months). |
| Overall Survival (OS) | The time from first day of study drug treatment to death for any cause | estimated about 24 months. |
| Treatment-Emergent Adverse Events (TEAEs) | Number of subjects with treatment emergent adverse events as assessed by CTCAE v5.0 | From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months). |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| NeoTX - 10303 | Tucson | Arizona | 85711 | United States |
| NeoTX - 10306 | Lone Tree | Colorado | 80124 | United States |
| NeoTX - 10304 | Minneapolis | Minnesota | 55404 | United States |
| NeoTX - 10100 | Morristown | New Jersey | 07962 | United States |
| NeoTX - 10308 | Austin | Texas | 78745 | United States |
| NeoTX - 10309 | Dallas | Texas | 75246 | United States |
| NeoTX - 10312 | El Paso | Texas | 79902 | United States |
| NeoTX - 10310 | Tyler | Texas | 75702 | United States |
| NeoTX - 10311 | Fairfax | Virginia | 22205 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
A single arm trial
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment | Subjects received obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP was administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel were 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg was administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP was given as monotherapy and not earlier than C7, cycles were of 28 days of duration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | 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 | 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 | Objective Response Rate (ORR) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and iRECIST for target lesions and assessed by CT scans 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; Overall Response (OR) = CR + PR | Efficacy Evaluable Population: patients completing at least one treatment cycle and having had an evaluable pre-treatment and one post-treatment tumor assessment (according to the iRECIST - criteria) in the absence of eligibility and compliance issues. | Posted | Number | 95% Confidence Interval | percentage of responders | From the first treatment to first CR or PR (estimated about 24 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | The proportion of subjects who achieve a best response of CR, PR or SD per Response Evaluation in Solid Tumors (iRECIST). | Efficacy Evaluable Population: patients completing at least one treatment cycle and having had an evaluable pre-treatment and one post-treatment tumor assessment (according to the iRECIST - criteria) in the absence of eligibility and compliance issues. | Posted | Number | 95% Confidence Interval | percentage of patients with SD, PR, CR | From the first administration of treatment till study completion (estimated about 24 months). |
| |||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration from first documentation of CR or PR (whichever occurs first) after the first administration of obinutuzumab pretreatment until death or progressive disease (PD) | Efficacy Evaluable Population: patients completing at least one treatment cycle and having had an evaluable pre-treatment and one post-treatment tumor assessment (according to the iRECIST - criteria) in the absence of eligibility and compliance issues. | Posted | Median | 95% Confidence Interval | months | estimated about 24 months. |
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS per Response Evaluation in Solid Tumors (iRECIST) | Efficacy Evaluable Population: patients completing at least one treatment cycle and having had an evaluable pre-treatment and one post-treatment tumor assessment (according to the iRECIST - criteria) in the absence of eligibility and compliance issues. | Posted | Mean | 95% Confidence Interval | months | From the first administration of treatment to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (estimated about 24 months). |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The time from first day of study drug treatment to death for any cause | Efficacy Evaluable Population: patients completing at least one treatment cycle and having had an evaluable pre-treatment and one post-treatment tumor assessment (according to the iRECIST - criteria) in the absence of eligibility and compliance issues. | Posted | Mean | 95% Confidence Interval | months | estimated about 24 months. |
| |||||||||||||||||||||||||||
| Secondary | Treatment-Emergent Adverse Events (TEAEs) | Number of subjects with treatment emergent adverse events as assessed by CTCAE v5.0 | Safety Subjects Population | Posted | Number | participants | From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months). |
|
Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment | Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration. NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1. Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2. Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle. | 6 | 38 | 16 | 38 | 38 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA v. 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v. 21.1 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA v. 21.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v. 21.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v. 21.1 | Systematic Assessment |
|
Study Sites or Principal Investigators shall not publish the Results or the outcomes of their individual participation in the Study, until after the completion of the Study at all participating sites and the review, analysis, and write-up of the Study by the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ilana Lorber, VP of Clinical Operations | NeoTX Therapeutics Ltd. | +972-3-912-5853 | 213 | ilanal@neotx.com |
| Jan 22, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C543500 | naptumomab estafenatox |
| D000077143 | Docetaxel |
| C543332 | obinutuzumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
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