NCT07123415招募中1 期
A Phase 1 Trial of APX-343A as Monotherapy or in Combination With Pembrolizumab to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Subjects With Advanced Solid Tumors
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
- 110
- 试验地点
- 3
- 主要终点
- To assess the safety and tolerability and to determine the MTD and/or RP2D of APX-343A monotherapy and in combination with pembrolizumab
研究概览
简要总结
This is a Phase 1, open-label, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APX-343A monotherapy (Part A) and in combination with pembrolizumab (Part B) in subjects with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥19 years, inclusive, at the time of informed consent.
- •Willing and able to give informed consent and to comply with the requirements of the study.
- •Histologically or cytologically confirmed advanced solid tumor.
- •Life expectancy of at least 3 months in the judgment of the investigator.
- •ECOG performance status of 0 to 1 during the screening period.
- •Measurable disease per RECIST v1.1 as assessed by the site investigator/radiology.
- •Archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
- •Subjects who have AEs due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline.
- •Adequate organ function as defined in the following table.
- •Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to the first dose of study drug.
- •Subjects with history of HCV infection are eligible if HCV viral load is undetectable at screening.
- •Male subjects must agree to use an adequate method of contraception.
- •Female subjects of childbearing potential must agree to use highly effective contraceptive methods, and to abstain from breastfeeding.
排除标准
- •Received any prior immunotherapy.
- •Received prior systemic anticancer therapy including investigational agents.
- •Received prior radiotherapy.
- •Received a live or live-attenuated vaccine .
- •Has received an investigational agent.
- •Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- •Known additional malignancy.
- •Known active CNS metastases and/or carcinomatous meningitis.
- •Active autoimmune disease.
- •History of (noninfectious) pneumonitis/interstitial lung disease.
- •Active, uncontrolled infection requiring systemic therapy.
- •Unable to swallow study drug or disease that interfere with proper absorption of study drug.
- •Significant cardiovascular disease.
- •Cerebrovascular accident.
- •History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the subject's ability to cooperate with the requirements of the study.
- •History of severe hypersensitivity to pembrolizumab and/or any of its excipients.
- •History of hypersensitivity to APX-343A and/or any of its excipients.
- •History of allogeneic tissue/solid organ transplant.
- •History of HIV infection or HIV positive at screening.
- •Subjects who have not adequately recovered from major surgery or have ongoing surgical complications.
研究组 & 干预措施
Part A : APX-343A
Experimental
Part A is a dose-escalation study of APX-343A monotherapy in subjects with advanced solid tumors.
干预措施: APX-343A (Drug)
Part B
Experimental
Part B is a dose-escalation study of APX-343A in combination with pembrolizumab, targeting subjects with advanced solid tumors.
干预措施: APX-343A (Drug)
Part B
Experimental
Part B is a dose-escalation study of APX-343A in combination with pembrolizumab, targeting subjects with advanced solid tumors.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
To assess the safety and tolerability and to determine the MTD and/or RP2D of APX-343A monotherapy and in combination with pembrolizumab
时间窗: From enrollment to 90 days after End Of Treatment
Number and severity of TEAEs according to NCI-CTCAE v5.0
次要结局
- Cmax of APX-343A(From enrollment to 3 weeks)
- AUC of APX-343A(From enrollment to 3 weeks)
- t1/2 of APX-343A(From enrollment to 3 weeks)
- Tmax of APX-343A(From enrollment to 3 weeks)
- CL of APX-343A(From enrollment to 3 weeks)
- Response rate according to RECIST v1.1 and iRECIST(Through study completion, an average of 1 year)
研究者
研究点 (3)
Loading locations...
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