NCT04679038Unknown1 期
SHR-1701 Plus Famitinib Malate in Advanced Solid Tumors: An Open-label, Multi-center, Phase I/II Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 222
- 试验地点
- 16
- 主要终点
- RP2D
研究概览
简要总结
This is an open-label, multi-center study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with metastatic or locally advanced solid tumor. There are two parts of the study: combinational therapy part and monotherapy part. Phase I of combinational therapy part is to determine the recommended dose for Phase II (RP2D) for famitinib in the combined regimen, then efficacy and safety of SHR-1701 plus famitinib (RP2D) will be further evaluated in the following Phase II in cohorts 1/2/3, with simon's two-stage design. Meanwhile, efficacy and safety of famitinib will also be assessed in cohorts 4/5 in the monotherapy part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Phase I of combinational therapy part: Histologically proven metastatic or locally advanced solid tumors, for which no effective standard treatment exists or standard therapy has failed.
- •Phase II of combinational therapy part and monotherapy part: Histologically confirmed metastatic or locally advanced selected solid tumor types with 0-2 prior lines of systemic therapy.
- •For cohorts 1 or 4, patients with biliary tract carcinoma failed to one prior systemic treatment. Patients with previous adjuvant/neo-adjuvant therapy completed within 6 months can be enrolled.
- •For cohort 2, patients with clear-cell renal cell carcinoma (or predominantly clear-cell subtype with primary tumor resected) after failure of no more than first-line standard therapy; For cohorts 3 or 5, patients with hepatocellular carcinoma must have progressed on prior first- or second-line standard therapy; Child-Pugh Class A; BCLC stage B or C, and not suitable for surgical or local therapy.
- •Subjects are 18 years old or older when signing the informed consent and gender is not limited.
- •Life expectancy of at least 12 weeks.
- •Eastern Cooperative Group (ECOG) performance status of 0 to
- •At least one measurable lesion according to RECIST version 1.
- •Tumor tissue must be available for biomarker analysis prior to the first dose of treatment, If not available, subjects can consult the investigator for enrollment agreement.
- •Adequate hematological, hepatic and renal function as defined in the protocol.
- •Subjects with HBV infection: HBV DNA<500 IU/mL or < 2500 copy/mL, must receive anti-HBV therapy.
- •Subjects with HCV-RNA(+) must receive antiviral therapy.
- •Able and willing to provide signed informed consent form, and able to comply with all procedures.
- •Other protocol defined inclusion criteria could apply.
排除标准
- •For cohorts 1 or 4: known ampullary cancer or mixed cancer (HCC-ICC).
- •For cohorts 3 or 5: known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; history of hepatic encephalopathy.
- •For subjects in combinational therapy part: prior treatment with any anti-PD-1/PD-L1, or anti-CTLA-4 agents (specifically targeting T-cell co-stimulation or checkpoint pathways), or TGF-β inhibitors.
- •For cohort 4: prior treatment with VEGFR directed therapies including famitinib.
- •Factors to affect oral administration.
- •Major surgery procedure within 28 days prior to the first dose of trial treatment (excluding prior diagnostic biopsy or PICC); anticancer treatment within 28 days before the first dose of trial treatment; subjects in combinational therapy part who have received systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment should also be excluded.
- •Moderate-to-severe ascites with clinical symptoms.
- •Active or history of central nervous system metastases.
- •Known genetic or acquired hemorrhage or thrombotic tendency.
- •History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage.
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
combinational therapy part
Experimental
SHR-1701 + famitinib
干预措施: SHR-1701 (Biological)
combinational therapy part
Experimental
SHR-1701 + famitinib
干预措施: Famitinib (Drug)
monotherapy part
Experimental
famitinib
干预措施: Famitinib (Drug)
结局指标
主要结局
RP2D
时间窗: First cycle (21 days)
Recommended phase-2 dosage
Objective response rate (ORR)
时间窗: up to approximately 3 years (anticipated)
Defined as complete or partial response per RECIST 1.1
次要结局
- DCR(up to approximately 3 years (anticipated))
- 6-month OS rate(From the start of treatment to 6 months)
- OS(up to approximately 3 years (anticipated))
- Clinically Significant Toxicity(First cycle (21 days))
- Cmax of SHR-1701(up to approximately 3 years (anticipated))
- C6h of Famitinib(up to approximately 6 months (anticipated))
- AUC0-24h,ss(up to approximately 3 years (anticipated)])
- AEs+SAEs(up to approximately 3 years (anticipated))
- DoR(up to approximately 3 years (anticipated))
- PFS(up to approximately 3 years (anticipated))
- Cmax,ss(up to approximately 3 years (anticipated))
- 12-month-OS rate(From the start of treatment to 12 months)
研究者
研究点 (16)
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