NCT05607563招募中1 期
A Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumors
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
- 54
- 试验地点
- 1
- 主要终点
- Dose Limited Toxicity（DLT）
研究概览
简要总结
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1009 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1009.
PM1009 is a new novel fully human anti-TIGIT x PVRIG bispecific antibody, containing a wildtype IgG1 Fc and has high monovalent affinity to each target, it can binds to both TIGIT and PVRIG overexpressing target cells and binds to TIGIT and PVRIG simultaneously.
详细描述
This is a single-arm, open-label, Phase I study contains dose escalation stage and dose expansion stage.
The dose escalation stage will be following the accelerated titration design and the classic 3+3 design, with a planned enrollment of 10 to 24 patients with advanced tumors.
The dose expansion stage will be used safe and tolerable doses, with a planned enrollment of 30 patients with advanced tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients participate in the study voluntarily and sign informed consent；
- •Male or female, aged 18 to 75 years (including boundary value);
- •Subjects with advanced tumor confirmed by histology or cytology fail to receive standard treatment, or there is no standard treatment scheme, or standard treatment is not applicable at this stage;
- •Having adequate organ function；
- •ECOG score is 0-1；
- •Expected survival ≥ 12 weeks；
- •There is at least one assessable tumor focus.
排除标准
- •History of severe allergic;
- •Those who have received anti-TIGIT or anti-PVRIG therapy in the past;
- •Patients who have grade ≥3 immune-mediated adverse event that associated with a prior immunotherapy;
- •Adverse reactions to previous antitumor therapy have not recovered to NCI-CTCAE V5.0 rating ≤ 1;
- •Current definite interstitial lung disease or non-infectious pneumonitis, except for local radiotherapy;
- •Patients ever received the following treatments or drugs prior to the study treatment:
- •Major organ surgery within 28 days prior to initiation of trial treatment;
- •Received live attenuated vaccine within 28 days prior to the study treatment;
- •Received antitumor therapy within 4 weeks prior to the study treatment;
- •Received systemic glucocorticoid within 14 days prior to the study treatment;
- •Active infection was present within 14 days before starting study treatment;
- •Those with known uncontrolled parenchymal or leptomeningeal metastases;
- •Patients with active autoimmune disease or a history of autoimmune disease with potential for relapse;
- •Patients with other active malignancies within 5 years prior to initiation of study treatment, except for locally treatable and cured malignancies;
- •History of severe cardiovascular and cerebrovascular diseases;
- •Patients with uncontrolled tumor-related pain;
- •Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- •History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
- •History of alcohol, psychotropic substance or drug abuse;
- •History of psychiatric disorders or poor compliance;
- •History of immunodeficiency, including a positive HIV antibody test;
- •Patients with active syphilis infection;
- •Patients with active hepatitis B or C;
- •Pregnant or lactating women;
- •Other conditions considered unsuitable for this study by investigator.
研究组 & 干预措施
PM1009 120 mg monotherapy
Experimental
PM1009 120 mg
干预措施: PM1009 injection (Drug)
PM1009 300 mg monotherapy
Experimental
PM1009 300 mg
干预措施: PM1009 injection (Drug)
PM1009 600 mg monotherapy
Experimental
PM1009 600 mg
干预措施: PM1009 injection (Drug)
PM1009 1200 mg monotherapy
Experimental
PM1009 1200 mg
干预措施: PM1009 injection (Drug)
结局指标
主要结局
Dose Limited Toxicity（DLT）
时间窗: up to 21 days
Occurrence of DLT after receiving PM1009 injection
次要结局
- Recommended Phase II Dose (RP2D)(Up to 30 days after last treatment)
- Maximum observed concentration (Cmax)(Up to 30 days after last treatment)
- Minimum observed concentration (Cmin)(Up to 30 days after last treatment)
- Area under the concentration-time curve (AUC0-last)(Up to 30 days after last treatment)
- AUC to the end of the dosing period(AUC0-tau)(Up to 30 days after last treatment)
- Accumulation ratio calculated based on Cmax (Rac_Cmax)(Up to 30 days after last treatment)
- Disease control rate (DCR)(Up to 24 months)
- Trough concentrations (Ctrough)(Up to 30 days after last treatment)
- Accumulation ratio calculated based on AUC (Rac_AUC)(Up to 30 days after last treatment)
- Anti-drug antibody (ADA)(Up to 30 days after last treatment)
- Time to Cmax (Tmax)(Up to 30 days after last treatment)
- Objective response rate (ORR)(Up to 24 months)
- Overall survival (OS)(Up to 24 months)
- Apparent terminal elimination half-life (t1/2)(Up to 30 days after last treatment)
- Progression-free survival (PFS)(Up to 24 months)
- Adverse Events（AE）and Serious Adverse Events（SAE）(Up to 30 days after last treatment)
研究者
研究点 (1)
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