Trial · NCT04234113
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | Through Cycle 1 (21 days) | * Grade (gr) 5 not related to disease progression or other causes * Gr ≥3 non-hematologic toxicity; exceptions: gr 3 nausea, vomiting or diarrhea controlled in 72 hours; gr 3 fatigue \<5 days; gr ≥3 correctable electrolyte abnormalities \<72 hours and no clinical complications; gr ≥3 amylase or lipase without clinical pancreatitis * Hy's law cases * Gr 3 AST or ALT or gr 3 bilirubinemia \>5 days * Hematologic DLTs: gr 4 neutropenia or thrombocytopenia \>7 days, febrile neutropenia, gr ≥3 thrombocytopenia with bleeding * Gr 4 immune-related AEs * Gr 3 or 4 non-infectious pneumonitis * Gr 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, not downgrading to gr ≤2 in 3 days despite maximal supportive care including systemic corticosteroids or to gr 1 or baseline in 14 days * Gr 2 pneumonitis not downgrading to gr 1 in 3 days * Gr 3 colitis * Part B and Part B1: Recurrent grade 2 pneumonitis |
| Primary | Number of Participants With Adverse Events (AEs) | Day 1 up to approximately 2 years and 2.5 months | Nanrilkefusp alfa related only |
| Primary | Number of Participants With Serious AEs (SAEs) | Day 1 up to approximately 2 years and 2.5 months | Nanrilkefusp alfa related only |
| Primary | Number of Participants With AEs Leading to Premature Discontinuation of Nanrilkefusp Alfa | Day 1 up to approximately 2 years and 2.5 months | Nanrilkefusp alfa related only |
| Primary | Number of Participants Who Died | Day 1 up to approximately 2 years and 2.5 months | Nanrilkefusp alfa-related deaths only |
| Primary | Number of Participants With Nanrilkefusp Alfa-related Clinical Laboratory Test Abnormalities (Coagulation; Hematology; Clinical Chemistry; Urinalysis; Thyroid and Cardiac Function) | Day 1 up to approximately 2 years and 2.5 months | The following laboratory parameters were assessed: * Coagulation: Prothrombin time, activated partial thromboplastin time, international normalized ratio, D-dimer, fibrinogen * Hematology: Hemoglobin, hematocrit, red blood cell count, reticulocytes, white blood cell count (with full differentiation), absolute lymphocyte count, platelet count * Clinical chemistry: Na, K, Cl, phosphate, Mg, Ca, albumin, total protein, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine clearance, creatinine, glucose (preferably fasting), urea or blood urea nitrogen, cholesterol, triglyceride, CRP, uric acid, amylase, lipase * Urinalysis: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination: red blood cell count, white blood cell count, epithelial cells, bacteria * Thyroid function: TSH, free triiodothyronine (T3), free thyroxine (T4) * Cardiac function: Cardiac troponin T |
| Secondary | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1 | Cycle 1 Day 1 | This outcome measure presents the overall nanrilkefusp apfa Cmax profile over Cycle 1 Day 1. |
| Secondary | Overall Activation Levels of Ki-67+ CD8+ T Cells on Day 6 of Cycle 1 | Cycle 1 Day 6 | The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of CD8+ Cells (10\^9/L) = Ki-67+ Cells of CD8+ Cells (%CD45+) x 0.01 x WBC" Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01. |
| Secondary | Overall Activation Levels of Ki-67+ CD8+ CD45RO+ CD45RA- T Cells on Day 6 of Cycle 1 | Cycle 1 Day 6 | The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: * Ki-67+ Cells of CD8+ Cells (10\^9/L) = Ki-67+ Cells of CD8+ Cells (%CD45+) x 0.01 x WBC * CD45RO+ CD45RA- (Memory) Cells of CD8+ Cells (10\^9/L) = CD45RO+ CD45RA- (Memory) Cells of CD8+ Cells (%CD45+) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01. Absolute count of CD45RO+ CD45RA- (Memory) Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01. |
| Secondary | Overall Activation Levels of Ki-67+ CD4+ T Cells on Day 6 of Cycle 1 | Cycle 1 Day 6 | The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of CD4+ Cells (10\^9/L) = Ki-67+ Cells of CD4+ Cells (%CD45+) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01. |
| Secondary | Overall Activation Levels of Ki-67+ NK Cells on Day 6 of Cycle 1 | Cycle 1 Day 6 | The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of CD3-CD56+ (NK) Cells (10\^9/L) = Ki-67+ Cells of CD3-CD56+ (NK) Cells (%CD45+) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01. |
| Secondary | Overall Activation Levels of Ki-67+ NKT Cells on Day 6 of Cycle 1 | Cycle 1 Day 6 | The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • CD3+CD56+ (NKT) Cells of CD45+ Live Cells (10\^9/L) = CD3+CD56+ (NKT) Cells of CD45+ Live Cells (%) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of Live Cells multiplied by WBC and 0.01. |
| Secondary | Overall Activation Levels of Ki-67+ Treg Cells on Day 6 of Cycle 1 | Cycle 1 Day 6 | The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of Treg Cells (10\^9/L) = Ki-67+ Treg Cells (%CD45+) x 0.01 x WBC" Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01. |
| Secondary | Objective Response Rate | Day 1 up to approximately 5 years 5 months | Based on investigator review of radiographic images according to Response Evaluation Criteria In Solid Tumors for immune-based therapeutics (iRECIST). Objective response rate according to iRECIST was defined as the percentage of participants with complete response according to iRECIST or partial response according to iRECIST for target lesions and assessed by CT/MRI. |
| Secondary | Duration of Response | Day 1 up to approximately 5 years 5 months | Duration of response according to iRECIST was defined as time to disease progression for participants with partial response or complete response according to iRECIST for target lesions and assessed by CT/MRI. |
| Secondary | Clinical Benefit Rate | Day 1 up to approximately 5 years 5 months | Based on investigator review of radiographic images according to iRECIST. Clinical benefit rate according to iRECIST was defined as the percentage of patients with partial responses, complete responses, and stable disease according to iRECIST for target lesions and assessed by CT/MRI. |
| Secondary | Progression-free Survival | Day 1 up to approximately 5 years 5 months | Progression-free survival according to iRECIST was defined as the time from the first day of study treatment to the first date of radiological disease progression according to iRECIST or death. |
| Secondary | Number of Participants With Anti-drug Antibodies at the End of Treatment | Day 1 until 30 (±2) days after the last dose of nanrilkefusp alfa, up to approximately 5 years 5 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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