NCT06297525招募中1 期
An Open-Label, Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of the CTPS1 Inhibitor STP938 in Adult Subjects With Advanced Solid Tumors, With a Safety Expansion in Advanced CTPS2 Null Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 13
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy.
The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.
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
- •Main Inclusion Criteria:
- •Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.
- •Male or female aged ≥ 18 years.
- •Advanced disease not curable by available therapies and requires systemic therapy.
- •Histologically confirmed diagnosis of eligible cancer type.
- •Must have tumor tissue available for biomarker testing.
- •Measurable disease (Part 1) and measurable disease per RECIST (Part2)
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Life expectancy > 3 months as assessed by the Investigator.
- •Adequate organ function (bone marrow, hepatic, renal function and coagulation).
- •All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment.
排除标准
- •Pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with contraception requirements.
- •Known active or symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal cord compression
- •Active malignancy within 2 years of study enrollment
- •Prior radiation within 2 weeks of start of therapy.
- •Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or <5 half-lives since completion of previous investigational therapy, whichever is shorter.
- •Uncontrolled intercurrent illness.
- •Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months.
- •Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.
- •Subjects with corrected QT interval >470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF).
研究组 & 干预措施
Phase 1a (Part 1, Dose Escalation)
Experimental
Up to 5 dose levels with STP938 administered as oral monotherapy
干预措施: STP938 (Drug)
Phase 1b (Part 2, Safety Expansion)
Experimental
Further evaluation of STP938 administered as oral monotherapy at the RP2D
干预措施: STP938 (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Through study completion, an average of 6 months
Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)
次要结局
- Time to reach maximum concentration (TMax)(9 Days)
- Maximum plasma concentration (Cmax)(9 Days)
- Evaluation of preliminary clinical activity of STP938(Through study completion, an average of 6 months)
- Area under the curve (AUC) of STP938(9 days)
- Evaluation of Duration of Response(Through study completion, an average of 6 months)
- Evaluation of Progression Free Survival(Through study completion, an average of 6 months)
- Evaluation of best overall response of STP938(Through study completion, an average of 6 months)
- Change in serum CA125 (ovarian cancer only)(Through study completion, an average of 6 months)
研究者
研究点 (13)
Loading locations...
相似试验
招募中
1 期
A Phase 1/2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell LymphomasLymphoma, B-CellLymphoma, T-CellNCT05463263Step Pharma, SAS180
招募中
1 期
Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid TumorsSolid Tumor, AdultNCT06088004Suzhou Abogen Biosciences Co., Ltd.218
已完成
1 期
Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2Solid TumorNCT03916094Shanghai Henlius Biotech11
招募中
1 期
A Phase 1 Study of FD-001 in Recurrent /Refractory (R/R)AML/NHL/MM/MDSAMLNHLNCT06731699Chengdu FenDi Pharmaceutical Co., Ltd.72
招募中
1 期
To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG)Gastric CancerNCT05514158RemeGen Co., Ltd.24