A Phase 1 Study to Evaluate the Efficacy and Safety of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- • Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
研究概览
简要总结
This is a Phase 1, open-label study evaluating the efficacy and safety of HRXG-K-1939 in combination with Adebrelimab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in patients with advanced solid tumors. HRXG-K-1939 will be administered to patients in a dose escalation regimen to determine a recommended dose for expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed the informed consent form and complied with protocols requirements;
- •Patients with advanced solid tumors that are suitable for immunotherapy;
- •ECOG Performance Status of 0 or 1;
- •Life expectancy ≥ 12 weeks;
- •At least one measurable disease per RECIST v1.1;
- •Tumor specimen availability;
- •Adequate marrow and organ function;
- •Have resolution of toxic effects from prior therapy to Grade 1 or less (except for Grade ≤2 alopecia or neuropathy) per CTCAE v5.0;
- •Patients with fertility are willing to use an adequate method of contraception.
排除标准
- •Previously detected positive driver genes (EGFR, ALK, ROS1, etc.);
- •Have leptomeningeal, or actively progressing CNS metastases (patients with stable brain metastases can be enrolled);
- •Uncontrolled pleural effusion, pericardial effusion, or ascites;
- •Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study;
- •Prior anti-cancer therapy (e.g., chemotherapy, radiotherapy, hormonal therapy, targeted therapy, immunotherapy, any other investigational or immunomodulatory drugs) within 21 days prior to initiation of study treatment;
- •Live-attenuated vaccination within 28 days prior to initiation of study treatment through 60 days after the end of study;
- •Systemic steroid therapy or other form of immunosuppressive therapy within 14 days prior to initiation of study treatment;
- •Any history of an immune-mediated Grade 4 adverse event or Grade 3 adverse event that resulted in permanent discontinuation;
- •Active or history of autoimmune disease;
- •Active tuberculosis or infection requiring treatment;
- •History of interstitial lung disease;
- •Allergic to research drug ingredients;
- •Prior malignancy within 5 years prior to study entry;
- •Solid organ or allogeneic bone marrow transplant;
- •HIV positive, HCV positive, HBV DNA copies ≥ 10^3;
- •Significant cardiovascular disease;
- •Other situations that are not suitable for inclusion in this study judged by investigator
研究组 & 干预措施
HRXG-K-1939 Combined with Adebrelimab
Dose Escalation:
HRXG-K-1939 at escalated dosages with Adebrelimab Experimental: Dose Expansion HRXG-K-1939 at recommended dose with Adebrelimab
干预措施: HRXG-K-1939 (Drug)
HRXG-K-1939 Combined with Adebrelimab
Dose Escalation:
HRXG-K-1939 at escalated dosages with Adebrelimab Experimental: Dose Expansion HRXG-K-1939 at recommended dose with Adebrelimab
干预措施: Adebrelimab (Drug)
结局指标
主要结局
• Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
时间窗: Baseline through 12 months after last HRXG-K-1939 dose
• Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
Dose Escalation Phase:RP2D
时间窗: 9 months
Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of HRXG-K-1939
次要结局
- Duration of Response (DoR)(12 months)
- Objective Response Rate(ORR)(12 months)
- Disease Control Rate (DCR)(12 months)
- Overall Survival (OS)(24 months)
- Adverse Events(AEs)(From consent to 90 days after the final dose of study drug)
- Progression Free Survival (PFS)(12 months)
- Biomarker analysis(Baseline through 12 months after last HRXG-K-1939 dose)