NCT05256381终止2 期
A Phase 2, Open-label, Single-arm, Multicenter Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced/Refractory Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 166
- 试验地点
- 54
- 主要终点
- Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
研究概览
简要总结
The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa in combination with pembrolizumab in selected tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Participants with the following histologically or cytologically confirmed solid tumor indications and line of treatment:
- •Non-small cell lung cancer (NSCLC).
- •Colorectal cancer.
- •Cutaneous squamous cell carcinoma (cSCC).
- •Advanced hepatocellular carcinoma (not applicable in France).
- •Ovarian cancer.
- •Have measurable disease per RECIST 1.
- •mCRPC participants with no measurable disease and only widespread bone disease must have a CTC count of ≥5 cells per 7.5 mL of blood.
- •Availability of tumor tissue from a fresh biopsy at screening unless the biopsy cannot be obtained due to safety reasons or non-accessibility of the tumor site. If it is not possible to obtain a fresh biopsy, every effort should be taken to retrieve an archival biopsy. Archived, fixed tumor tissue may only be collected if taken preferentially after completion of the most recent systemic tumor therapy and within 12 months prior to the first dose of study treatment.
- •Eastern Cooperative Oncology Group (ECOG) score 0-
- •Have recovered from all AEs (except alopecia) due to previous therapies to grade ≤1 (excluding alopecia) or have stable grade 2 neuropathy.
- •Have adequate organ function as defined below:
- •Hematology:
- •Absolute neutrophil count ≥1500/μL.
- •Platelets ≥100 000/μL.
- •Hemoglobin ≥9.0 g/dL .
- •Renal function: Creatinine clearance as measured by glomerular filtration rate ≥30 mL/min using Cockcroft-Gault equation.
- •Hepatic function: Alanine transaminase (ALT)/aspartate transaminase (AST) ≤2.5× upper limit of normal (ULN) and total bilirubin ≤1.5×ULN or direct bilirubin ≤ ULN in participants without liver metastasis. In participants with liver metastasis, ALT/AST ≤5×ULN is allowed but total bilirubin must be ≤2×ULN.
- •Prothrombin time and activated partial thromboplastin time ≤1.5×ULN.
- •Participants must not have active hepatitis B or hepatitis C infection.
- •Adequate contraception must be applied in all women of childbearing potential (WOCBP) and in male participants.
排除标准
- •Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a grade ≥3 AE.
- •Prior exposure to agonists of interleukin (IL)-2 or IL-
- •Prior systemic anti-cancer therapies, including investigational agents:
- •Less than 4 weeks for systemic chemotherapy and immuno-oncology therapies; and for tyrosine kinase inhibitors 4 weeks or 5 half-lives (whichever is shorter).
- •Less than 4 weeks from major surgeries and not recovered adequately.
- •Has received prior radiotherapy within 2 weeks of the start of study interventions or have had a history of radiation pneumonitis.
- •NSCLC indication only: Received radiation therapy to the lung >30 Gy within 6 months.
- •Has received a live or live-attenuated vaccine within 30 days.
- •Clinically significant cardiac abnormalities including prior history of any of the following:
- •Cardiomyopathy, with left ventricular ejection fraction ≤ 50%.
- •Congestive heart failure of New York Heart Association grade ≥
- •History of clinically significant artery or coronary heart disease.
- •Prolongation of QTcF >450 msec .
- •Clinically significant cardiac arrythmia that cannot be controlled with adequate medication.
- •Uncontrolled hypertension defined as systolic blood pressure >160 mmHg, diastolic blood pressure >110 mmHg.
- •Prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
- •Prior allogeneic tissue/solid organ transplant.
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy.
- •History of or serology positive for human immunodeficiency virus (HIV).
- •Has a known additional malignancy that is progressing or has required active treatment within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ that have undergone potentially curative therapy are not excluded.
- •Has known active central nervous system metastases and/or carcinomatous meningitis, unless stable.
- •Had severe hypersensitivity (grade ≥3) to pembrolizumab and/or any of its excipients.
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- •History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
- •Has an active infection requiring systemic therapy.
- •Has any condition that might confound the results of the study or interfere with the participant's participation for the full duration of the study.
研究组 & 干预措施
Nanrilkefusp Alfa and Pembrolizumab
Experimental
Participants will be treated with 12 μg/kg of nanrilkefusp alfa on Day 1, Day 2, Day 8, and Day 9 of each 3-week cycle in combination with 200 mg pembrolizumab on Day 1 of each 3-week cycle.
干预措施: Nanrilkefusp Alfa (Drug)
Nanrilkefusp Alfa and Pembrolizumab
Experimental
Participants will be treated with 12 μg/kg of nanrilkefusp alfa on Day 1, Day 2, Day 8, and Day 9 of each 3-week cycle in combination with 200 mg pembrolizumab on Day 1 of each 3-week cycle.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
时间窗: Day 1 up to approximately 2 years and 2 months
次要结局
- Number of Patients With a Treatment-emergent Adverse Event(Day 1 up to approximately 2 years and 2 months)
- Number of Patients With an Adverse Event of Special Interest(Day 1 up to approximately 2 years and 2 months)
- Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST)(Day 1 up to approximately 2 years and 2 months)
- Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response(Day 1 up to approximately 2 years and 2 months)
- Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response(Day 1 up to approximately 2 years and 2 months)
- Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease(Day 1 up to approximately 2 years and 2 months)
- Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease(Day 1 up to approximately 2 years and 2 months)
- Number of Patients With Best Overall Response According to iRECIST: Complete Response(Day 1 up to approximately 2 years and 2 months)
- Number of Patients With Best Overall Response According to iRECIST: Partial Response(Day 1 up to approximately 2 years and 2 months)
- Number of Patients With Best Overall Response According to iRECIST: Stable Disease(Day 1 up to approximately 2 years and 2 months)
- Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease(Day 1 up to approximately 2 years and 2 months)
- Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease(Day 1 up to approximately 2 years and 2 months)
- Duration of Response According to RECIST 1.1(Day 1 up to approximately 2 years and 2 months)
- Duration of Response According to iRECIST(Day 1 up to approximately 2 years and 2 months)
- Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1(Day 1 up to approximately 2 years and 2 months)
- Percentage of Patients With Clinical Benefit Rate According to iRECIST(Day 1 up to approximately 2 years and 2 months)
- Progression-free Survival According to RECIST 1.1(Day 1 up to approximately 2 years and 2 months)
- Progression-free Survival According to iRECIST(Day 1 up to approximately 2 years and 2 months)
- Time to Response According to RECIST 1.1(Day 1 up to approximately 2 years and 2 months)
- Time to Response According to iRECIST(Day 1 up to approximately 2 years and 2 months)
- Duration of Response According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1(Day 1 up to approximately 2 years and 2 months)
- Percentage of Patients With Clinical Benefit Rate According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1(Day 1 up to approximately 2 years and 2 months)
- Progression-free Survival According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1(Day 1 up to approximately 2 years and 2 months)
- Percentage of Patients With Circulating Tumor Cell Count Conversion as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1(Day 1 up to approximately 2 years)
- Percentage of Patients With Confirmed Prostate-specific Antigen Decline of ≥50% as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1(Day 1 up to approximately 2 years)
- Time to Confirmed Prostate-specific Antigen Progression as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1(Day 1 up to approximately 2 years)
- Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration(Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration)
- Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration(Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration)
- Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1(Cycle 4 Day 1, approximately 9 weeks)
研究者
研究点 (54)
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