Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors
- Conditions
- MelanomaThyroid CancerRenal Cell CarcinomaNon Small Cell Lung CancerSmall-cell Lung CancerBladder CancerMerkel Cell CarcinomaSkin Squamous Cell CarcinomaMicrosatellite Instability HighTriple Negative Breast Cancer
- Interventions
- Registration Number
- NCT04234113
- Lead Sponsor
- SOTIO Biotech AG
- Brief Summary
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
- Detailed Description
This study will assess the safety and tolerability of SO-C101 administered as monotherapy and in combination with an anti-PD-1 antibody (pembrolizumab) in patients with selected relapsed/refractory advanced/metastatic solid tumors (renal cell carcinoma, non-small cell lung cancer, small-cell lung cancer, bladder cancer, melanoma, Merkel-cell carcinoma, skin squamous-cell carcinoma, microsatellite instability high solid tumors, triple-negative breast cancer, mesothelioma, thyroid cancer, thymic cancer, cervical cancer, biliary track cancer, hepatocellular carcinoma, ovarian cancer, gastric cancer, head and neck squamous-cell carcinoma, and anal cancer).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 115
- Patients with selected histologically or cytologically confirmed advanced and/or metastatic solid tumors who are refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
- ECOG performance score 0-1. Patients with ECOG is 2 to be discussed with the sponsor's medical monitor to be agreed for inclusion.
- Estimated life expectancy of ≥3 months
- Washout periods: 4 weeks for chemotherapy, 4 weeks or 5 half-lives (whichever shorter) for biologic agents including immuno-oncology therapy and 4 weeks from major surgeries, definitive radiotherapy and 2 weeks after palliative radiotherapy
- At least one measurable lesion per iRECIST in a non-irradiated port. If in a previously irradiated port, must have demonstrated progression since best response to radiation therapy.
- Have fully recovered from previous treatment to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy
- Adequate organ system function
- Negative serum pregnancy test, if woman of child-bearing potential (WOCBP; non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
- Accessible tumor tissue available for fresh biopsy
-
Key exclusion criteria (Part A and B)
- Patient with untreated CNS metastases and/or leptomeningeal carcinomatosis (see list of all exclusion criteria for details)
- Known additional malignancy that is progressing and/or requires active treatment.
- Prior exposure to drugs that are agonists of IL-2- or IL-15-like but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar)
- History of and current interstitial lung disease or fibrosis and pneumonitis; patients with clinically significant or oxygen requiring COPD or any chronic inflammatory disease (sarcoidosis etc.)
- Has received a live vaccine within 30 days of planned start of study therapy (see list of all exclusion criteria for details)
- Absolute WBC count ≤ 2.0 ×109/L;
- ALC ≤0.5×109/L
- Absolute neutrophil count ≤1.0 ×109/L
- Platelet count ≤100×109/L
- Pregnant or breastfeeding women
- Any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma, or history of syndrome that required systemic steroids (except the allowed doses) or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy (see list of all exclusion criteria for details)
- Specific co-morbidities (see list of all exclusion criteria for details)
- Is hypersensitive to any of the ingredients of pembrolizumab drug product (KeytrudaTM)
- History of solid organ transplantation or hematopoietic stem cell transplantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Experimental: Part A (nanrilkefusp alfa monotherapy) Nanrilkefusp alfa Drug: Nanrilkefusp alfa Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab) Nanrilkefusp alfa Drug: Nanrilkefusp alfa Drug: Pembrolizumab Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab) Pembrolizumab Drug: Nanrilkefusp alfa Drug: Pembrolizumab Experimental: Part A1 (nanrilkefusp alfa divided dosing, monotherapy) Nanrilkefusp alfa Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%) Experimental: Part B1 (nanrilkefusp alfa divided dosing, combined with pembrolizumab) Pembrolizumab Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%) Drug: Pembrolizumab Part D1 (nanrilkefusp alfa divided dosing, monotherapy, expansion at the RP2D identified in Part A1) Nanrilkefusp alfa Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%) Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, relapsed/refractory advanced/metastatic melanoma Experimental: Part B1 (nanrilkefusp alfa divided dosing, combined with pembrolizumab) Nanrilkefusp alfa Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%) Drug: Pembrolizumab Experimental: Part D (nanrilkefusp alfa monotherapy, expansion at the RP2D identified in Part A) Nanrilkefusp alfa Drug: Nanrilkefusp alfa Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, relapsed/refractory advanced/metastatic melanoma
- Primary Outcome Measures
Name Time Method Part A: Number of participants with dose-limiting toxicities (DLTs) Through Cycle 1 (21 days) Adverse events (AEs) as per NCI CTCAE version 5.0:
* Grade 5 not related to disease progression or other causes
* Grade ≥3 non-hematologic toxicity; exceptions: grade 3 nausea, vomiting or diarrhea controlled in 72 hours; grade 3 fatigue \<5 days; grade ≥3 correctable electrolyte abnormalities \<72 hours and no clinical complications; grade ≥3 amylase or lipase without clinical pancreatitis
* Hy's law cases
* Grade 3 AST or ALT or grade 3 bilirubinemia \>5 days
* Hematologic DLTs:
* Grade 4 neutropenia or thrombocytopenia \>7 days
* Febrile neutropenia
* Grade ≥3 thrombocytopenia with bleeding
* Grade 4 immune-related AEs
* Grade 3 or 4 non-infectious pneumonitis
* Grade 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, not downgrading to grade ≤2 in 3 days despite maximal supportive care including systemic corticosteroids or to grade 1 or baseline in 14 days
* Grade 2 pneumonitis not downgrading to grade 1 in 3 days
* Grade 3 colitisPart A1: Number of participants with DLTs Through Cycle 1 (21 days) AEs as per NCI CTCAE version 5.0:
* Grade 5 not related to disease progression or other causes
* Grade ≥3 non-hematologic toxicity; exceptions: grade 3 nausea, vomiting or diarrhea controlled in 72 hours; grade 3 fatigue \<5 days; grade ≥3 correctable electrolyte abnormalities \<72 hours and no clinical complications; grade ≥3 amylase or lipase without clinical pancreatitis
* Hy's law cases
* Grade 3 AST or ALT or grade 3 bilirubinemia \>5 days
* Hematologic DLTs:
* Grade 4 neutropenia or thrombocytopenia \>7 days
* Febrile neutropenia
* Grade ≥3 thrombocytopenia with bleeding
* Grade 4 immune-related AEs
* Grade 3 or 4 non-infectious pneumonitis
* Grade 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, not downgrading to grade ≤2 in 3 days despite maximal supportive care including systemic corticosteroids or to grade 1 or baseline in 14 days
* Grade 2 pneumonitis not downgrading to grade 1 in 3 days
* Grade 3 colitisPart B: Number of participants with DLTs Through Cycle 1 (21 days) AEs as per NCI CTCAE version 5.0:
* Grade 5 not related to disease progression or other causes
* Grade ≥3 non-hematologic toxicity; exceptions: grade 3 nausea, vomiting or diarrhea controlled in 72 hours; grade 3 fatigue \<5 days; grade ≥3 correctable electrolyte abnormalities \<72 hours and no clinical complications; grade ≥3 amylase or lipase without clinical pancreatitis
* Hy's law cases
* Grade 3 AST or ALT or grade 3 bilirubinemia \>5 days
* Hematologic DLTs:
* Grade 4 neutropenia or thrombocytopenia \>7 days
* Febrile neutropenia
* Grade ≥3 thrombocytopenia with bleeding
* Grade 4 immune-related AEs
* Grade 3 or 4 non-infectious pneumonitis
* Grade 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, not downgrading to grade ≤2 in 3 days despite maximal supportive care including systemic corticosteroids or to grade 1 or baseline in 14 days
* Grade 2 pneumonitis not downgrading to grade 1 in 3 days
* Recurrent grade 2 pneumonitis
* Grade 3 colitisPart B1: Number of participants with DLTs Through Cycle 1 (21 days) AEs as per NCI CTCAE version 5.0:
* Grade 5 not related to disease progression or other causes
* Grade ≥3 non-hematologic toxicity; exceptions: grade 3 nausea, vomiting or diarrhea controlled in 72 hours; grade 3 fatigue \<5 days; grade ≥3 correctable electrolyte abnormalities \<72 hours and no clinical complications; grade ≥3 amylase or lipase without clinical pancreatitis
* Hy's law cases
* Grade 3 AST or ALT or grade 3 bilirubinemia \>5 days
* Hematologic DLTs:
* Grade 4 neutropenia or thrombocytopenia \>7 days
* Febrile neutropenia
* Grade ≥3 thrombocytopenia with bleeding
* Grade 4 immune-related AEs
* Grade 3 or 4 non-infectious pneumonitis
* Grade 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, not downgrading to grade ≤2 in 3 days despite maximal supportive care including systemic corticosteroids or to grade 1 or baseline in 14 days
* Grade 2 pneumonitis not downgrading to grade 1 in 3 days
* Recurrent grade 2 pneumonitis
* Grade 3 colitisPart A: Number of participants with AEs Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part A1: Number of participants with AEs Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part B: Number of participants with AEs Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part B1: Number of participants with AEs Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part D: Number of participants with AEs Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part A: Number of participants with serious AEs (SAEs) Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part A1: Number of participants with SAEs Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part B: Number of participants with SAEs Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part B1: Number of participants with SAEs Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part D: Number of participants with SAEs Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part A: Number of participants with AEs leading to premature discontinuation of nanrilkefusp alfa Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part A1: Number of participants with AEs leading to premature discontinuation of nanrilkefusp alfa Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part B: Number of participants with AEs leading to premature discontinuation of nanrilkefusp alfa Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part B1: Number of participants with AEs leading to premature discontinuation of nanrilkefusp alfa Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part D: Number of participants with AEs leading to premature discontinuation of nanrilkefusp alfa Day 1 up to approximately 3 years Nanrilkefusp alfa related only
Part A: Number of participants who died Day 1 up to approximately 3 years Nanrilkefusp alfa-related deaths only
Part A1: Number of participants who died Day 1 up to approximately 3 years Nanrilkefusp alfa-related deaths only
Part B: Number of participants who died Day 1 up to approximately 3 years Nanrilkefusp alfa-related deaths only
Part B1: Number of participants who died Day 1 up to approximately 3 years Nanrilkefusp alfa-related deaths only
Part D: Number of participants who died Day 1 up to approximately 3 years Nanrilkefusp alfa-related deaths only
Part A: 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 3 years The following laboratory parameters will be 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 TPart A1: 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 3 years The following laboratory parameters will be 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 TPart B: 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 3 years The following laboratory parameters will be 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 TPart B1: 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 3 years The following laboratory parameters will be 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 TPart D: 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 3 years The following laboratory parameters will be 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 Outcome Measures
Name Time Method Part A: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 1 hour (+/-15 minutes) Cycle 1 Day 1, 1 hour (+/-15 minutes) After 12 μg/kg nanrilkefusp alfa administration
Part A1: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 1 hour (+/-15 minutes) Cycle 1 Day 1, 1 hour (+/-15 minutes) After 12 μg/kg nanrilkefusp alfa administration
Part B: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 1 hour (+/-15 minutes) Cycle 1 Day 1, 1 hour (+/-15 minutes) After 12 μg/kg nanrilkefusp alfa administration
Part D: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 1 hour (+/-15 minutes) Cycle 1 Day 1, 1 hour (+/-15 minutes) After 12 μg/kg nanrilkefusp alfa administration
Part A: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 4 hours (+/-15 minutes) Cycle 1 Day 1, 4 hours (+/-15 minutes) After 12 μg/kg nanrilkefusp alfa administration
Part A1: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 4 hours (+/-15 minutes) Cycle 1 Day 1, 4 hours (+/-15 minutes) After 12 μg/kg nanrilkefusp alfa administration
Part B: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 4 hours (+/-15 minutes) Cycle 1 Day 1, 4 hours (+/-15 minutes) After 12 μg/kg nanrilkefusp alfa administration
Part D: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 4 hours (+/-15 minutes) Cycle 1 Day 1, 4 hours (+/-15 minutes) After 12 μg/kg nanrilkefusp alfa administration
Part A: Overall activation levels of Ki-67+ CD8+ T cells on day 6 of cycle 1 Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A1: Overall activation levels of Ki-67+ CD8+ T cells on day 6 of cycle 1 Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part B: Overall activation levels of Ki-67+ CD8+ T cells on day 6 of cycle 1 Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part D: Overall activation levels of Ki-67+ CD8+ T cells on day 6 of cycle 1 Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A: Overall activation levels of Ki-67+ CD8+ CD45RO+ CD45RA- T cells on day 6 of cycle 1 Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A1: Overall activation levels of Ki-67+ CD8+ CD45RO+ CD45RA- T cells on day 6 of cycle 1 Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part B: Overall activation levels of Ki-67+ CD8+ CD45RO+ CD45RA- T cells on day 6 of cycle 1 Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part D: Overall activation levels of Ki-67+ CD8+ CD45RO+ CD45RA- T cells on day 6 of cycle 1 Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A: Overall activation levels of Ki-67+ CD4+ T cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A1: Overall activation levels of Ki-67+ CD4+ T cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part B: Overall activation levels of Ki-67+ CD4+ T cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part D: Overall activation levels of Ki-67+ CD4+ T cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A: Overall activation levels of Ki-67+ NK cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A1: Overall activation levels of Ki-67+ NK cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part B: Overall activation levels of Ki-67+ NK cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part D: Overall activation levels of Ki-67+ NK cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A: Overall activation levels of Ki-67+ NKT cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A1: Overall activation levels of Ki-67+ NKT cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part B: Overall activation levels of Ki-67+ NKT cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part D: Overall activation levels of Ki-67+ NKT cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A: Overall activation levels of Ki-67+ Treg cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A1: Overall activation levels of Ki-67+ Treg cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part B: Overall activation levels of Ki-67+ Treg cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part D: Overall activation levels of Ki-67+ Treg cells on day 6 of cycle 1 at 12 μg/kg nanrilkefusp alfa Day 6 of Cycle 1 At 12 μg/kg nanrilkefusp alfa
Part A: Objective response rate (ORR) Day 1 up to approximately 3 years Based on investigator review of radiographic images according to Response Evaluation Criteria In Solid Tumors for immune-based therapeutics (iRECIST)
Part A1: ORR Day 1 up to approximately 3 years Based on investigator review of radiographic images according to iRECIST
Part B: ORR Day 1 up to approximately 3 years Based on investigator review of radiographic images according to iRECIST
Part D: ORR Day 1 up to approximately 3 years Based on investigator review of radiographic images according to iRECIST
Part A: Duration of response (DoR) Day 1 up to approximately 3 years DoR according to iRECIST
Part A1: DoR Day 1 up to approximately 3 years DoR according to iRECIST
Part B: DoR Day 1 up to approximately 3 years DoR according to iRECIST
Part D: DoR Day 1 up to approximately 3 years DoR according to iRECIST
Part A: Clinical benefit rate (CBR) Day 1 up to approximately 3 years CBR according to iRECIST
Part A1: CBR Day 1 up to approximately 3 years CBR according to iRECIST
Part B: CBR Day 1 up to approximately 3 years CBR according to iRECIST
Part D: CBR Day 1 up to approximately 3 years CBR according to iRECIST
Part A: Progression-free survival (PFS) Day 1 up to approximately 3 years PFS according to iRECIST
Part A1: PFS Day 1 up to approximately 3 years PFS according to iRECIST
Part B: PFS Day 1 up to approximately 3 years PFS according to iRECIST
Part D: PFS Day 1 up to approximately 3 years PFS according to iRECIST
Part A: Number of participants with anti-drug antibodies (ADAs) at the end of treatment End of treatment with nanrilkefusp alfa Against nanrilkefusp alfa
Part A1: Number of participants with ADAs at the end of treatment End of treatment with nanrilkefusp alfa Against nanrilkefusp alfa
Part B: Number of participants with ADAs at the end of treatment End of treatment with nanrilkefusp alfa Against nanrilkefusp alfa
Part B1: Number of participants with ADAs at the end of treatment End of treatment with nanrilkefusp alfa Against nanrilkefusp alfa
Part D: Number of participants with ADAs at the end of treatment End of treatment with nanrilkefusp alfa Against nanrilkefusp alfa
Related Research Topics
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Trial Locations
- Locations (12)
Institut Gustave Roussy
🇫🇷Paris, France
University Hospital Sanchinarro
🇪🇸Madrid, Spain
Hôpitaux Universitaires de Marseille Timone
🇫🇷Marseille, France
Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péče
🇨🇿Brno, Czechia
Vall d'Hebron Institute of Oncology
🇪🇸Barcelona, Spain
Institut de Cancerologie de L'Ouest
🇫🇷Saint Herblain, France
Hopital Saint Louis
🇫🇷Paris, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Centre Léon Bérard
🇫🇷Lyon, France