NCT04648202进行中（未招募）1 期
A Phase 1/1b Open-Label Study to Evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination With Pembrolizumab, in Subjects With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 82
- 试验地点
- 9
- 主要终点
- Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
研究概览
简要总结
This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Measurable disease
- •Eastern Cooperative Oncology Group Performance Status 0-
- •Highly effective contraception if risk of conception exists
- •A female subject is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception
- •Subjects with HIV who are healthy and how a low risk of acquired immunodeficiency syndrome related outcomes
- •For combination part: Subjects must have histologically confirmed locally advanced, unresectable or metastatic solid tumours where there is regulatory approval for use of pembrolizumab as a monotherapy agent
排除标准
- •Prior systemic anticancer therapy within 28 days or 5- half-lives, whichever is shorter, before the first dose of study drug.
- •Prior therapy with any OX40 agonist, CD137 (4-1BB) agonist, CD40 agonist, GITR, or CD27 targeting therapy (single agent or combination).
- •Prior radiotherapy within 2 weeks of start of study treatment.
- •HIV infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- •Uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis, primary CNS tumours, or solid tumours with CNS metastases as the only measurable disease.
- •Prior history of any grade ≥3 immune-related AE (irAE) that has not improved to grade ≤1; any grade ≥3 irAE that resulted in discontinuation of treatment, significant (grade ≥3 NCI CTCAE Version 5.0) treatment-related cytokine release syndrome.
- •Use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal antibodies or their excipients, persistent grade ≥1 NCI CTCAE Version 5 toxicity related to prior therapy or any condition that would significantly impair and/or prohibit the participant's participation in the study, as per the investigator's judgement.
- •Vaccination with a live vaccine within 30 days before first dose of study drug.
- •Participants with a known additional malignancy that is progressing or has required active treatment in the past 3 years.
- •Participants with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
研究组 & 干预措施
FS120
Experimental
Open-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts
干预措施: FS120 (Drug)
结局指标
主要结局
Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
时间窗: 24 months
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)
时间窗: 24 months
Safety and tolerability will be evaluated by collection of AEs, SAEs and DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
次要结局
未报告次要终点
研究者
研究点 (9)
Loading locations...
相似试验
终止
1 期
Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing CancersSquamous Cell Carcinoma of Head and NeckCarcinoma, Non-Small-Cell LungAdvanced Solid TumorRefractory TumorMetastatic TumorColorectal NeoplasmsNCT05099549NKGen Biotech, Inc.11
招募中
1 期
A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC PatientsMetastatic Castration-resistant Prostate CancerNCT06155084Hinova Pharmaceuticals Inc.84
已完成
1 期
A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate CancerMetastatic Castration-resistant Prostate CancerNCT05252364Hinova Pharmaceuticals Aus Pty Ltd22
招募中
1 期
IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian CancerPlatinum-resistant Ovarian CancerNCT05551507InxMed (Shanghai) Co., Ltd.150
已完成
1 期
IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ AdenocarcinomaGastric CancerNCT05327231InxMed (Shanghai) Co., Ltd.33