NCT05718557进行中（未招募）1 期
A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PYX-106 in Subjects With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 47
- 试验地点
- 20
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.
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
- •Participants with histologically or cytologically confirmed solid tumors who have relapsed, been non-responsive, or have developed disease progression through standard therapy.
- •Histologically or cytologically confirmed solid tumors (see details below):
- •For the dose escalation, the following solid tumors are allowed in participants who have relapsed, been non-responsive, or have developed disease progression through standard therapy and in participants for whom standard of care therapy that prolongs survival is unavailable or unsuitable (according to the Investigator and after informing the Medical Monitor): non small cell lung cancer (without driver mutations/translocations), breast cancer, endometrial cancer, thyroid cancer, kidney cancer, cholangiocarcinoma, bladder cancer, colorectal cancer, and head and neck squamous cell carcinoma.
- •Clinical sites must provide archived tissue or conduct fresh tumor biopsy (formalin-fixed paraffin-embedded [FFPE]; enough to create a minimum of 14 slides). Fresh biopsy pre-treatment is preferred, archival tissue (preferably obtained within 1 year prior to the first infusion of PYX-106) is acceptable if fresh biopsy is not medically feasible, per Investigator, at Screening. Both fresh and archival tissue samples must be collected by core needle biopsy or surgical resection. Fine needle aspirates are not permitted.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or
- •Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 criteria (by local Investigator). Participant must have radiographic evidence of disease progression per Investigator following the most recent line of treatment.
- •Life expectancy of >3 months, in the opinion of the Investigator.
排除标准
- •History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma, adequately treated; other adequately treated Stage 1 or 2 cancers currently in complete remission; any other cancer that has been in complete remission for >2 years or cancer of low risk of recurrence; or any treated or monitored indolent cancer that is unlikely to cause mortality in 5 years.
- •Known symptomatic brain metastases requiring >10 mg/day of prednisolone (or its equivalent) at the time of signing informed consent.
- •Continuance of toxicities due to prior anti-cancer agents that do not recover to Grade 1 prior to start of PYX-106 treatment, except for alopecia or endocrine deficiencies treated with stable hormone replacement therapy.
- •Presence of Grade ≥2 peripheral neuropathy.
- •Major surgery within 4 weeks prior to the start of PYX-106 treatment, as defined by the Investigator.
- •Received palliative radiation therapy within 14 days prior to the start of PYX-106 treatment.
- •Received a live vaccine within 28 days prior to the first dose of study treatment and while participating in the study.
研究组 & 干预措施
PYX-106 Dose Escalation
Experimental
Participants will receive escalating doses of PYX-106 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PYX-106, and to determine the recommended dose(s).
干预措施: PYX-106 (Drug)
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Day 1 up to approximately 19 months
Type, incidence, seriousness and causality of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
时间窗: Day 1 to Day 28
次要结局
- Area Under the Time Concentration Curve from Time 0 to the End of the Dosing Interval (AUCtau) of PYX-106(Day 1 up to approximately 2 years)
- Duration of Response (DOR)(Day 1 up to approximately 2 years)
- Progression Free Survival (PFS)(Day 1 up to approximately 2 years)
- Disease Control Rate (DCR)(Day 1 up to approximately 2 years)
- Area Under the Time Concentration Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-106(Day 1 up to approximately 2 years)
- Time to Response(Day 1 up to approximately 2 years)
- Area Under the Time Concentration Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-106(Day 1 up to approximately 2 years)
- Maximum Concentration (Cmax) of PYX-106(Day 1 up to approximately 2 years)
- Time to Maximum Concentration (Tmax) of PYX-106(Day 1 up to approximately 2 years)
- Half Life (t1/2) of PYX-106(Day 1 up to approximately 2 years)
- Objective Response Rate (ORR)(Day 1 up to approximately 2 years)
- Overall Survival (OS)(Day 1 up to approximately 2 years)
研究者
研究点 (20)
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