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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 115
- 试验地点
- 12
- 主要终点
- Part A1: Number of participants with nanrilkefusp alfa-related clinical laboratory test abnormalities (coagulation; hematology; clinical chemistry; urinalysis; thyroid and cardiac function)
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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
排除标准
- •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
研究组 & 干预措施
Experimental: Part A (nanrilkefusp alfa monotherapy)
Drug: Nanrilkefusp alfa
干预措施: Nanrilkefusp alfa (Drug)
Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab)
Drug: Nanrilkefusp alfa Drug: Pembrolizumab
干预措施: Nanrilkefusp alfa (Drug)
Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab)
Drug: Nanrilkefusp alfa Drug: Pembrolizumab
干预措施: Pembrolizumab (Drug)
Experimental: Part A1 (nanrilkefusp alfa divided dosing, monotherapy)
Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%)
干预措施: Nanrilkefusp alfa (Drug)
Experimental: Part B1 (nanrilkefusp alfa divided dosing, combined with pembrolizumab)
Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%) Drug: Pembrolizumab
干预措施: Nanrilkefusp alfa (Drug)
Experimental: Part B1 (nanrilkefusp alfa divided dosing, combined with pembrolizumab)
Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%) Drug: Pembrolizumab
干预措施: Pembrolizumab (Drug)
Experimental: Part D (nanrilkefusp alfa monotherapy, expansion at the RP2D identified in Part A)
Drug: Nanrilkefusp alfa Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, relapsed/refractory advanced/metastatic melanoma
干预措施: Nanrilkefusp alfa (Drug)
Part D1 (nanrilkefusp alfa divided dosing, monotherapy, expansion at the RP2D identified in Part A1)
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
干预措施: Nanrilkefusp alfa (Drug)
结局指标
主要结局
Part A1: Number of participants with nanrilkefusp alfa-related clinical laboratory test abnormalities (coagulation; hematology; clinical chemistry; urinalysis; thyroid and cardiac function)
时间窗: 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
Part B: Number of participants with nanrilkefusp alfa-related clinical laboratory test abnormalities (coagulation; hematology; clinical chemistry; urinalysis; thyroid and cardiac function)
时间窗: 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
Part B1: Number of participants with nanrilkefusp alfa-related clinical laboratory test abnormalities (coagulation; hematology; clinical chemistry; urinalysis; thyroid and cardiac function)
时间窗: 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
Part D: Number of participants with nanrilkefusp alfa-related clinical laboratory test abnormalities (coagulation; hematology; clinical chemistry; urinalysis; thyroid and cardiac function)
时间窗: 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
Part A: Number of participants with dose-limiting toxicities (DLTs)
时间窗: 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 colitis
Part A1: Number of participants with DLTs
时间窗: 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 colitis
Part B: Number of participants with DLTs
时间窗: 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 colitis
Part B1: Number of participants with DLTs
时间窗: 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 colitis
Part A: Number of participants with AEs
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa related only
Part A1: Number of participants with AEs
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa related only
Part B: Number of participants with AEs
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa related only
Part B1: Number of participants with AEs
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa related only
Part D: Number of participants with AEs
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa related only
Part A: Number of participants with serious AEs (SAEs)
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa related only
Part A1: Number of participants with SAEs
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa related only
Part B: Number of participants with SAEs
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa related only
Part B1: Number of participants with SAEs
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa related only
Part D: Number of participants with SAEs
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa related only
Part A: Number of participants who died
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa-related deaths only
Part A1: Number of participants who died
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa-related deaths only
Part B: Number of participants who died
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa-related deaths only
Part B1: Number of participants who died
时间窗: Day 1 up to approximately 3 years
Nanrilkefusp alfa-related deaths only
Part D: Number of participants who died
时间窗: 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)
时间窗: 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
次要结局
- Part A: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 1 hour (+/-15 minutes)(Cycle 1 Day 1, 1 hour (+/-15 minutes))
- Part A1: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 1 hour (+/-15 minutes)(Cycle 1 Day 1, 1 hour (+/-15 minutes))
- Part B: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 1 hour (+/-15 minutes)(Cycle 1 Day 1, 1 hour (+/-15 minutes))
- Part D: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 1 hour (+/-15 minutes)(Cycle 1 Day 1, 1 hour (+/-15 minutes))
- Part A: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 4 hours (+/-15 minutes)(Cycle 1 Day 1, 4 hours (+/-15 minutes))
- Part A1: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 4 hours (+/-15 minutes)(Cycle 1 Day 1, 4 hours (+/-15 minutes))
- Part B: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 4 hours (+/-15 minutes)(Cycle 1 Day 1, 4 hours (+/-15 minutes))
- Part D: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 4 hours (+/-15 minutes)(Cycle 1 Day 1, 4 hours (+/-15 minutes))
- Part A: Overall activation levels of Ki-67+ CD8+ T cells on day 6 of cycle 1(Day 6 of Cycle 1)
- Part A1: Overall activation levels of Ki-67+ CD8+ T cells on day 6 of cycle 1(Day 6 of Cycle 1)
- Part B: Overall activation levels of Ki-67+ CD8+ T cells on day 6 of cycle 1(Day 6 of Cycle 1)
- Part D: Overall activation levels of Ki-67+ CD8+ T cells on day 6 of cycle 1(Day 6 of Cycle 1)
- Part A: Overall activation levels of Ki-67+ CD8+ CD45RO+ CD45RA- T cells on day 6 of cycle 1(Day 6 of Cycle 1)
- Part A1: Overall activation levels of Ki-67+ CD8+ CD45RO+ CD45RA- T cells on day 6 of cycle 1(Day 6 of Cycle 1)
- Part B: Overall activation levels of Ki-67+ CD8+ CD45RO+ CD45RA- T cells on day 6 of cycle 1(Day 6 of Cycle 1)
- Part D: Overall activation levels of Ki-67+ CD8+ CD45RO+ CD45RA- T cells on day 6 of cycle 1(Day 6 of Cycle 1)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Part A: Objective response rate (ORR)(Day 1 up to approximately 3 years)
- Part A1: ORR(Day 1 up to approximately 3 years)
- Part B: ORR(Day 1 up to approximately 3 years)
- Part D: ORR(Day 1 up to approximately 3 years)
- Part A: Duration of response (DoR)(Day 1 up to approximately 3 years)
- Part A1: DoR(Day 1 up to approximately 3 years)
- Part B: DoR(Day 1 up to approximately 3 years)
- Part D: DoR(Day 1 up to approximately 3 years)
- Part A: Clinical benefit rate (CBR)(Day 1 up to approximately 3 years)
- Part A1: CBR(Day 1 up to approximately 3 years)
- Part B: CBR(Day 1 up to approximately 3 years)
- Part D: CBR(Day 1 up to approximately 3 years)
- Part A: Progression-free survival (PFS)(Day 1 up to approximately 3 years)
- Part A1: PFS(Day 1 up to approximately 3 years)
- Part B: PFS(Day 1 up to approximately 3 years)
- Part D: PFS(Day 1 up to approximately 3 years)
- Part A: Number of participants with anti-drug antibodies (ADAs) at the end of treatment(End of treatment with nanrilkefusp alfa)
- Part A1: Number of participants with ADAs at the end of treatment(End of treatment with nanrilkefusp alfa)
- Part B: Number of participants with ADAs at the end of treatment(End of treatment with nanrilkefusp alfa)
- Part B1: Number of participants with ADAs at the end of treatment(End of treatment with nanrilkefusp alfa)
- Part D: Number of participants with ADAs at the end of treatment(End of treatment with nanrilkefusp alfa)