NCT07363967
招募中
1 期
A Phase I First-in-Human Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of SWA1211 Tablets in Subjects With Advanced Solid Tumors
Beijing StoneWise Technology Co., Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月13日最近更新:
干预措施SWA1211
概览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Beijing StoneWise Technology Co., Ltd
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
概览
简要总结
The goal of this phase I, first-in-human, open-label study is to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SWA1211 in subjects with advanced solid tumors. It includes a Phase Ia dose escalation study and a Phase Ib dose expansion study. The main questions it aims to answer are:
- Assess the safety and tolerability of SWA1211 in subjects with advanced solid tumors.
- Identify the dose-limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase II dose (RP2D) of SWA1211.
- Assess the PK characteristics of SWA1211.
- Evaluate the preliminary anti-tumor activity of SWA1211.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are fully informed of the purpose, nature, method, and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document before any study procedure.
- •Subjects aged between 18 to 75 years old, male or female when signing the informed consent form (ICF).
- •Study population:
- •Phase Ia (Dose Escalation Study): Subjects with histologically or cytologically confirmed advanced solid tumors, who have failed standard treatments, have no available standard treatment, or are not suitable for standard treatment at present.
- •Phase Ib (Dose Expansion Study): Subjects with histologically or cytologically confirmed advanced solid tumors, who have failed standard treatments, have no available standard treatment, or are not suitable for standard treatment at present. The specific tumor types will be adjusted based on the results of Phase Ⅰa (dose escalation study).
- •Tumor tissue samples (preferable but not mandatory; fresh or archived) from patients will be collected during the screening period to assay the expression of HPK
- •However, patient enrollment is not based on HPK1 expression levels.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy of at least 3 months.
- •The function of bone marrow reserve and organs must meet the following requirements (without ongoing continuous supportive treatment):
排除标准
- •Known to be allergic to SWA1211 tablets or any of their excipients (Polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer; Vitamin E polyethylene glycol succinate, VE-TPGS 1000; Hypromellose; Propyl gallate; Methanol; Dichloromethane; Sodium lauryl sulfate; Microcrystalline cellulose; Manitol; Crospovidon; Silicon dioxide; Sodium stearyl fumarate; Film coating premix (Gastric dissolve type)).
- •Prior treatment with hematopoietic progenitor cell kinase 1 (HPK1) inhibitors.
- •Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immune checkpoint inhibitor therapy, or other anti-tumor therapies within 4 weeks or 5 times the half-life of the drugs (whichever is longer) before the first dose of IP, except for the following items:
- •Have used nitrosourea or Mitomycin C within 6 weeks before the first dose of IP.
- •Have used oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 times the half-life of the drugs before the first dose of IP (whichever is longer).
- •Have used herbal therapies with anti-tumor indications within 2 weeks before the first dose of IP.
- •4.Have received other clinical study drugs or treatments within 4 weeks before the first dose of IP, or still being within the safe follow-up period of other clinical study drugs or treatments.
- •5.Have received systemic glucocorticoids (\> 10 mg/day of prednisone or equivalent), or other immunosuppressants within 14 days before the first dose of IP, with the following exceptions:
- •Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent).
- •Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption.
研究组 & 干预措施
Phase 1a: Dose Escalation Study
Experimental
An accelerated titration design (ATD) combined with a traditional 3+3 dose escalation design of SWA1211 will be used. Six dose-escalation cohorts are planned.
干预措施: SWA1211 (Drug)
Phase 1b: Dose Expansion Study
Experimental
The trial will proceed to the dose expansion study after completion of dose escalation (Phase 1a) for SWA1211, with 1 to 2 cohorts, each with 20 ~ 30 subjects.
干预措施: SWA1211 (Drug)
结局指标
主要结局
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
1\. Safety profile: adverse events (AEs, including irAEs), clinical laboratory tests (hematology, urinalysis, blood biochemistry, coagulation tests, cardiac enzymes, and cardiac troponin I (cTnI)), physical examination, vital signs, 12-lead electrocardiograms (12-lead ECG), ECOG, etc.
次要结局
未报告次要终点
研究者
研究点 (1)
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