NCT07172802招募中1 期
An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Incidence of Dose-Limiting Toxicities (DLTs) (Dose escalation phase)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-108, as a single agent, in patients with advanced or metastatic solid tumors
详细描述
This is an open-label, multicenter, dose escalation and expansion, phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of GI-108 as a single agent in advanced or metastatic solid tumors. A control arm is not included.
The study is composed of two phases:
- Dose escalation phase
- Dose expansion phase The dose escalation phase will enroll up to 36 patients with advanced or metastatic solid tumors. At least 3 dose-limiting toxicity (DLT) evaluable patients will be enrolled in each cohort during the dose escalation to establish a maximum tolerated dose (MTD) or tentative recommended phase 2 dose (RP2D). Enrollment in each cohort may be extended to enroll additional 4~7 patients (aiming to recruit upto 10 patients including DLT evaluable patients per cohort), potentially enriched in certain tumor types and/or characteristics to confirm safety, PK and/or pharmacodynamics (PD) of GI-108. The Safety Monitoring Committee (SMC) will determine extension of each cohort based on the review of all available clinical data including efficacy, safety, PK and/or PD. Of the 4 planned cohorts in the dose escalation phase, up to 3 cohorts may be extended to include additional patients based on safety, efficacy PK and/or PD data. The evidence of enrollment extension should be documented for each cohort during dose escalation phase.
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
- •Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatoryguidelines) at the time of screening.
- •Has adequate organ and marrow function as defined in protocol.
- •Measurable disease as per RECIST v1.
- •ECOG performance status 0-
- •Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy,other prior systemic anti-cancer therapy, or surgery must have resolved to Grade≤1, except alopecia and Grade 2 peripheral neuropathy.
- •HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol.
排除标准
- •Has known active CNS metastases and/or carcinomatous meningitis. An active second malignancy.
- •Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.
- •Has active tuberculosis or has a known history of active tuberculosis. Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.
- •History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.
- •Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •Previous immunotherapies related to mode of action of GI-
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroidtherapy or any other form of immunosuppressive medications within 2 weeksprior to Cycle 1 Day 1.
研究组 & 干预措施
GI-108
Experimental
Dose escalation: GI-108 intravenous (IV), multiple ascending doses Dose optimization: GI-108 intravenous (IV), sRP2D
干预措施: GI-108 (Drug)
结局指标
主要结局
Incidence of Dose-Limiting Toxicities (DLTs) (Dose escalation phase)
时间窗: Study Day 1, assessed up to DLT period (3 weeks after treatment)
Number and proportion of subjects experiencing DLTs during dose escalation, used to determine MTD and/or RP2D.
Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose escalation phase)
时间窗: From Day 1 through study completion (up to ~24 months)
Number and proportion of subjects with immune-related AEs, graded per CTCAE v5.0.
Objective Response Rate (ORR) according to RECIST version 1.1 (Dose expansion phase)
时间窗: Study Day 1, assessed up to approximately 24 months
Based on Investigator review of radiographic imaging
次要结局
- Objective Response Rate (ORR) according to RECIST version 1.1 (Dose escalation phase)(Study Day 1, assessed up to approximately 24 months)
- Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose expansion phase)(Day 1 through study completion, up to ~24 months)
- Disease Control Rate (DCR)(Study Day 1, assessed up to approximately 24 months)
- Duration of objective response (DoR)(Study Day 1, assessed up to approximately 24 months)
- Progression-free survival (PFS)(6-month, 12-month, and 18-month)
- Overall survival (OS)(12-month and 18-month)
- Peak plasma concentration (Cmax) of GI-108(Study Day 1, assessed up to approximately 24 months)
- Half-life of GI-108 (T1/2)(Study Day 1, assessed up to approximately 24 months)
- Area under the plasma concentration versus time curve (AUC) of GI-108(Study Day 1, assessed up to approximately 24 months)
- Clearance of GI-108(Study Day 1, assessed up to approximately 24 months)
- Volume of distribution (Vd) of GI-108 after administration(Study Day 1, assessed up to approximately 24 months)
研究者
研究点 (3)
Loading locations...
相似试验
招募中
1 期
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)Advanced Solid TumorMetastatic Solid TumorSoft Tissue Sarcoma (STS)Platinum-resistant Ovarian Cancer (PROC)Hepatocellular Carcinoma (HCC)Colorectal Cancer (CRC)HER2 Negative Breast CancerRenal Cell Carcinoma (RCC)Cutaneous MelanomaNCT05824975GI Innovation, Inc.358
进行中（未招募）
1 期
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT05835986Hoffmann-La Roche70
已完成
1 期
Study of TAK-733 in Adult Patients With Advanced Nonhematologic MalignanciesAdvanced Non-hematologic MalignanciesAdvanced Metastatic MelanomaNCT00948467Millennium Pharmaceuticals, Inc.51
招募中
1 期
Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell MalignanciesNCT06980116Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.85
招募中
1 期
A Study on the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of CAN106 in Subjects With PNHPNHHemolysisNCT05539248CARE Pharma Shanghai Ltd.78