NCT06963502尚未招募1 期
A Phase Ib Study Evaluating the Safety, Tolerability , Pharmacokinetics，Activity and Immunogenicity of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
Jiangsu Hansoh Pharmaceutical Co., Ltd.2 个研究点 分布在 1 个国家目标入组 762 人开始时间: 2025年5月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 762
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Event(s) (AEs)
研究概览
简要总结
This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics, Activity and Immunogenicity of HS-10370 in Combination With Other Anti-cancer Therapies in Chinese patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in and Colorectal cancer(CRC) and non-Small cell lung cancer (NSCLC).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women greater than or equal to 18 years
- •At least one measurable lesion in accordance with RECIST 1.1
- •Must have an ECOG performance status of 0 or
- •Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.
- •Documentation of the presence of a KRAS G12C mutation
- •Estimated life expectancy ≥12 weeks.
- •Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit.
- •The subjects are able to comply with the process of the protocol.
排除标准
- •Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.
- •Active brain metastases.
- •Patients with uncontrolled pleural, ascites or pericardial effusion
- •Spinal cord compression
- •Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- •Subjects with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.
- •History of other primary malignancies.
- •Inadequate bone marrow reserve or organ functions.
- •Abnormal cardiac examination results.
- •Severe, uncontrolled or active cardiovascular disorders.
- •Diabetes ketoacidosis or hyperglycemia hyperosmolality
- •Uncontrolled hypertension.
- •Severe bleeding symptoms or bleeding tendencies.
- •Severe arteriovenous thrombosis occurred
- •Serious infection.
- •Continuous use of glucocorticoids
- •Active infectious diseases.
- •Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
- •Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child Pugh B-grade cirrhosis.
- •Interstitial lung disease (ILD).
- •Serious neurological or mental disorders.
- •Active autoimmune diseases
研究组 & 干预措施
Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab
Experimental
干预措施: HS-20117 (Drug)
Arm 1:HS-10370 dose 1+ HS-20117 dose 3
Experimental
干预措施: HS-10370 (Drug)
Arm 1:HS-10370 dose 1+ HS-20117 dose 3
Experimental
干预措施: HS-20117 (Drug)
Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab
Experimental
干预措施: HS-10370 (Drug)
Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab
Experimental
干预措施: Adebrelimab (Drug)
Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy
Experimental
干预措施: HS-10370 (Drug)
Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy
Experimental
干预措施: HS-20117 (Drug)
Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy
Experimental
干预措施: Capecitabine (Drug)
Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy
Experimental
干预措施: Oxaliplatin (Drug)
Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy
Experimental
干预措施: HS-10370 (Drug)
Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy
Experimental
干预措施: HS-20117 (Drug)
Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy
Experimental
干预措施: Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan (Drug)
Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5
Experimental
干预措施: HS-10370 (Drug)
Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5
Experimental
干预措施: HS-20117 (Drug)
Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5
Experimental
干预措施: HS-20093 (Drug)
Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab
Experimental
干预措施: HS-10370 (Drug)
Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab
Experimental
干预措施: Adebrelimab (Drug)
Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab
Experimental
干预措施: HS-20093 (Drug)
Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy
Experimental
干预措施: HS-10370 (Drug)
Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy
Experimental
干预措施: Adebrelimab (Drug)
Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy
Experimental
干预措施: HS-20093 (Drug)
Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy
Experimental
干预措施: platinum (cisplatin or carboplatin) (Drug)
结局指标
主要结局
Number of Participants with Adverse Event(s) (AEs)
时间窗: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).
An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment. Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
次要结局
- Overall Response Rate (ORR)(From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).)
- Disease Control Rate (DCR)(From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).)
- Time to Response (TTR)(Time from Cycle 1 Day 1 until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, up to 2 years (each cycle is 14 days).)
- Duration of Response (DOR)(Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years)
- Progression-Free Survival (PFS)(Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years)
- Overall survival (OS)(Cycle 1 Day 1 to date of death from any cause, up to 5 years (each cycle is 14 days))
- Plasma Concentrations of HS-10370(Cycle 1 Day 1 to date of death from any cause. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation, up to 2 years. (each cycle is 14 days))
- Maximum plasma concentration (Cmax)(Cycle 1 Day 1 to date of death from any cause, up to 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (each cycle is 14 days))
- Time of maximum concentration (Tmax)(Cycle 1 Day 1 to date of death from any cause, up to 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (each cycle is 14 days))
研究者
研究点 (2)
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