A Phase 1B/2A Study to Assess the Safety, Tolerability, Pharmacokinetic and Anti-tumoral Activity of EXS21546 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 5
- 主要终点
- Safety of EXS21546 in combination with nivolumab.
研究概览
简要总结
A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor in patients with advanced solid tumours.
详细描述
A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor, nivolumab, in patients with advanced solid tumours, non small cell lung cancer and renal cell carcinoma.
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
- •Aged ≥ 18 years at time of informed consent.
- •Previous histologically confirmed diagnosis of RCC or NSCLC having received previously checkpoint inhibitors as part of a SoC regimen.
- •Consent to mandatory paired tumour biopsies of at least one tumour site accessible for repeat biopsies. Planned sites for tumour biopsies must not have been previously irradiated and could be a target lesion of >2 cm diameter according to RECIST v1.1 and must be approved on a case-by-case basis by the Sponsor.
- •Measurable disease as per RECIST v1.1 and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).
排除标准
- •Any anti-tumour therapy, including investigational therapies, within 4 weeks prior to the first dose of EXS
- •Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per CTCAE v5.
- •Concurrent other malignancy that could interfere with response evaluation.
- •Symptomatic central nervous system (CNS) malignancy or metastases. Screening of symptomatic participants without history of CNS metastases is not required. Participants with asymptomatic CNS lesions should have completed standard therapy for their CNS lesions 60 days prior to study enrolment.
- •History of interstitial lung disease and/or prior immunotherapy-related pneumonitis.
- •Patients who have had or are scheduled to have major surgery < 28 days prior to the first dose of study drug.
研究组 & 干预措施
EXS21546
EXS21546 Granule in Capsule for oral administration
干预措施: EXS21546 (Drug)
结局指标
主要结局
Safety of EXS21546 in combination with nivolumab.
时间窗: Through study completion, an average of 6 months
Incidence of treatment-emergent adverse events (TEAEs) and SAEs characterised by type, incidence, severity (graded by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0), seriousness, timing and relationship to EXS21546 dosing.
Dose-limiting toxicities (DLTs) of EXS21546 in combination with nivolumab.
时间窗: Through dose escalation completion, an average of 6 months
Incidence of dose limiting toxicities (DLTs) during Cycle 1 (initial 28 days) of treatment with escalating doses of EXS21546 in combination with an approved dose of nivolumab.
Preliminary anti-tumoural activity of EXS21546 in combination with nivolumab.
时间窗: Through study completion, an average of 6 months
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Treatment adherence of EXS21546 in combination with nivolumab.
时间窗: Through study completion, an average of 6 months
Number of doses recorded in the treatment diary.
Tolerability of EXS21546 in combination with nivolumab.
时间窗: Through study completion, an average of 6 months
Frequency of dose interruptions, dose reductions and dose intensity achieved.
次要结局
未报告次要终点