NCT06470763已完成1 期
A First-in-human, Open-label, Multicenter Phase I/II Study to Evaluate the Safety and Anti-tumor Activity of ANV600 as Single Agent and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (EXPAND-1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Anaveon AG
- 入组人数
- 63
- 试验地点
- 25
- 主要终点
- Phase I dose escalation: Incidence of Dose Limiting Toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab combination with pembrolizumab
研究概览
简要总结
The purpose of study ANV600-001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity and antitumor activity of ANV600 administered as a single agent or in combination with pembrolizumab in adult participants with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant provides written informed consent for the trial;
- •Life-expectancy ≥ 3 months;
- •Able to comply with the Protocol as judged by the Investigator;
- •≥ 18 years of age on day of signing informed consent;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- •Measurable disease per RECIST v1.1;
- •Adequate organ function, defined as:
- •Absolute neutrophil count (ANC) ≥1200/µL;
- •Platelet count ≥100 000/µL;
- •Hemoglobin ≥9.0 g/dL;
- •Measured or calculated creatinine clearance ≥50 mL/min;
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases);
- •Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN;
- •Phase I: Advanced unresectable or metastatic solid tumors for which no standard of care treatments are available, or participants who cannot tolerate such treatment;
- •Phase II: Tumor-specific cohorts in adult participants with advanced solid tumors:
- •Cohort A: Unresectable Stage III or Stage IV cutaneous melanoma (excl. mucosal and uveal), which has progressed on/after treatment with a PD-1/L1 checkpoint inhibitor;
- •Cohort B: Unresectable or metastatic squamous or non-squamous non-small cell lung cancer (NSCLC) not eligible for an approved targeted therapy, which has progressed on/after treatment with a PD-1/L1 checkpoint inhibitor;
- •Cohort C: Recurrent and/or unresectable/metastatic head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal carcinoma), after platinum failure and a PD-1/L1 checkpoint inhibitor.
- •Additional inclusion criteria apply as per study protocol
排除标准
- •Pancreatic cancer (e.g. PDAC) (Phase I only);
- •Primary or secondary adrenal insufficiency (Phase I only);
- •History of allergic reactions attributed to any of the excipients of ANV600, such as sucrose, histidine or polysorbate
- •For combination only: severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients;
- •Investigational agent (including investigational device) within 4 weeks or an interval of five half-lives of the respective investigational agent prior to study Day 1, whichever is shorter;
- •Received IL-2 or IL-2 analogues as anti-cancer therapy within 18 months prior to study Day 1 (except IL-2 given in combination with cell therapy [e.g. TILs]);
- •Not recovered (i.e. ≤ Grade 1 at baseline) from AEs resulting from prior immunotherapies with the following exceptions:
- •Autoimmune AEs controlled by replacement therapy (e.g., hypothyroidism, adrenal insufficiency)
- •Vitiligo or alopecia
- •Received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to treatment; Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible. Participants with endocrine related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
- •For combination only: Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE;
- •Active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;
- •Additional malignancy that is progressing or has required active treatment within the past 3 years;
- •Active autoimmune disease that has required systemic treatment in the past 2 years;
- •Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug;
- •Allogeneic tissue/solid organ or stem cell transplant;
- •History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease;
- •Active infection requiring systemic therapy;
- •Additional exclusion criteria apply per study protocol
研究组 & 干预措施
ANV600 in combination with pembrolizumab (KEYTRUDA®)
Experimental
干预措施: ANV600 + pembrolizumab (KEYTRUDA®) (Drug)
ANV600 single agent
Experimental
干预措施: ANV600 (Drug)
结局指标
主要结局
Phase I dose escalation: Incidence of Dose Limiting Toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab combination with pembrolizumab
时间窗: Day 1 up to 24 months
Phase I dose escalation: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab
时间窗: Day 1 up to 24 months
Phase II: Objective Response Rate (ORR) using RECIST v1.1
时间窗: Day 1 up to 24 months
Phase II: Duration of Response (DOR) using RECIST v1.1
时间窗: Day 1 up to 24 months
Phase I: Incidence of dose limiting toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab.
Phase I: Incidence of dose limiting toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab.
Phase I: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab.
Phase I: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab.
Phase II: Objective response rate (ORR) using RECIST v1.1.
Phase II: Objective response rate (ORR) using RECIST v1.1.
Phase II: Duration of response (DOR) using RECIST v1.1.
Phase II: Duration of response (DOR) using RECIST v1.1.
次要结局
- Phase I Dose escalation: Serum concentration of ANV600 following a single dose and after repeated dosing(Day 1 up to 24 months)
- Phase I Dose escalation: Immunogenicity as indicated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (nAb)(Day 1 up to 24 months)
- Phase I Dose escalation: Objective response rate (ORR) using RECIST v1.1(Day 1 up to 24 months)
- Phase I Dose escalation: Duration of response (DOR) using RECIST v1.1(Day 1 up to 24 months)
- Phase II: Progression-free survival (PFS)(Day 1 up to 24 months)
- Phase II: Overall Survival (OS)(Day 1 up to 24 months)
- Phase II: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab(Day 1 up to 24 months)
- Phase II: PK parameters based on ANV600 serum levels following a single dose and after repeated dosing(Day 1 up to 24 months)
- Phase II: Immunogenicity as indicated by the incidence of antidrug antibodies (ADA) and neutralizing antibodies (nAb)(Day 1 up to 24 months)
- Phase I: PK parameters based on ANV600 serum levels following a single dose and after repeated dosing.
- Phase I: Immunogenicity as indicated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (nAb).
- Phase I: ORR using RECIST v1.1.
- Phase I: DOR using RECIST v1.1.
- Phase II: Progression-free Survival (PFS).
- Phase II: Overall survival (OS).
- Phase II: Frequency and severity of TEAEs with ANV600 and in combination with pembrolizumab.
- Phase II: PK parameters based on ANV600 serum levels following a single dose and after repeated dosing.
- Phase II: Immunogenicity as indicated by the incidence of ADA and nAb.
研究者
研究点 (25)
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