NCT05275374尚未招募1 期
A Dose-escalation and Expansion Phase I/IIa Study of XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation (ENHANCE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 221
- 主要终点
- Characterize the safety of XP-102.
研究概览
简要总结
This is a first-in-human multi-center study which will be conducted in advanced malignant solid tumors patients. The solid tumor type is limited to melanoma, colorectal, non-small-cell lung, and thyroid cancer with positive BRAF V600 mutation. This study is divided into three stages: Phase Ia: a dose-escalation phase of XP-102; Phase Ib: a dose-escalation and sample size expansion phase of XP-102 plus trametinib; Phase IIa: an expansion phase of XP-102 plus trametinib.
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
- •≥18 years of age
- •Advanced malignant solid tumor patients with a BRAF V600 mutation (limited to melanoma, colorectal cancer, non-small cell lung cancer, or thyroid cancer).
- •Must have failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Prior treatment with BRAF inhibitors and/or MEK inhibitors is permitted；
- •At least one measurable lesion (brain metastasis must not be the only measurable lesion) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1);
- •ECOG performance status of 0 or 1;
- •Expected survival ≥ 3 months;
- •Adequate liver, renal, coagulation, cardiac, and hematologic function.
- •A negative pregnancy test if female patient is of reproductive potential.
- •For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study.
- •Patients must agree to, and be capable of, adhering to the study visit schedule and all other protocol requirements;
- •Patients must understand and voluntarily sign the written informed consent form, before the initiation of any study-specific procedures in the trial.
排除标准
- •Active central nervous system (CNS) lesions. However, patients with asymptomatic and brain metastases who received treatment (including targeted brain radiotherapy, surgical treatment, glucocorticoid or other treatments) without disease progression for ≥ 3 months are eligible.
- •Patients who received radiotherapy, immunotherapy, hormone therapy, targeted therapy, biotherapy, traditional Chinese medicine therapy, chemotherapy or any clinical trial treatment within 14 days before the first dose.
- •Patients who have persistent toxicity caused by previous chemotherapeutic drugs or radiotherapy has not recovered to lower than grade 2 (except hair loss) according to CTCAE version 5.0;
- •Patients who are allergic to active substances or excipients of XP-102 or trametinib.
- •Significant traumatic injury within 28 days before the first dose of the investigational drug, or if major surgery is anticipated during the course of study treatment;
- •According to the judgment of the investigator, patients with dysphagia, or any gastrointestinal diseases that may affect drug absorption or activity;
- •Administration of strong inhibitors or inducers of CYP3A4 liver metabolic enzymes within 14 days before the first dose of the investigational drug;
- •Patients who are receiving drugs that may prolong QT interval and unable or unwilling to stop treatment or switch to other alternative treatment before study enrollment;
- •Symptomatic active fungal, bacterial and/or viral infections; including known HIV, active hepatitis B, active hepatitis C or active syphilis infection.
- •Any poorly controlled disorders (such as serious mental, neurological, cardiovascular, respiratory, digestive, urinary, bleeding and coagulation, or other system diseases) that may significantly affect the clinical trial;
- •Other situations not suitable for participation in the study as judged by the investigator.
研究组 & 干预措施
Part 1 - XP-102 Dose Escalation
Experimental
XP-102
干预措施: XP-102 (Drug)
Part 2 - XP-102 + Trametinib Dose Escalation
Experimental
XP-102 plus Trametinib
干预措施: XP-102 (Drug)
Part 2 - XP-102 + Trametinib Dose Escalation
Experimental
XP-102 plus Trametinib
干预措施: Trametinib (Drug)
Part 3 - XP-102 + Trametinib Dose Expansion
Experimental
XP-102 plus Trametinib
干预措施: XP-102 (Drug)
Part 3 - XP-102 + Trametinib Dose Expansion
Experimental
XP-102 plus Trametinib
干预措施: Trametinib (Drug)
结局指标
主要结局
Characterize the safety of XP-102.
时间窗: 28 days
Number of participants with treatment related adverse events.
Evaluate the pharmacokinetics of XP-102.
时间窗: 28 days
Blood plasma concentration.
Establish maximum tolerated dose of XP-102.
时间窗: 28 days
Number of participants with dose limiting toxicity
次要结局
- Evaluate clinical activity/efficacy of XP-102.(Approximately every 8 weeks (up to 2 years))
- Evaluate the pharmacokinetics of XP-102 + trametinib.(28 days)
- Characterize tolerability of XP-102 in combination with trametinib.(28 days)
- Evaluate the pharmacokinetics of XP-102 administered with food(4 days)
研究者
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