First-in-human Phase 1/2 Trial of EGL-001 in Adult Patients with Selected Advanced and/or Metastatic Solid Tumors (Protocol Number : EGL-121)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Dose-limiting toxicities (DLTs) when patients are receiving weekly administration of EGL-001 and proportion of patients with adverse events (AEs), treatment-emergent AEs (TEAEs), and serious AEs (SAEs) between the first dose of study drug and up to 90 days after the last dose of study drug.
研究概览
简要总结
The Primary Objectives for the Part 1 (dose escalation) are to evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) during weekly administration of EGL-001 leading to the recommended selected doses of EGL-001 monotherapy or in combination with pembrolizumab in adult patients with selected advanced/metastatic solid tumors and to evaluate the safety and tolerability of EGL-001 monotherapy administration in a 3-weekly (Q3W) schedule.
The Primary Objective for the Part 2 (dose expansion) is to evaluate preliminary efficacy as defined by objective response rate (ORR) for the selected doses of EGL-001 monotherapy and/or in combination with pembrolizumab in adult patients with selected advanced/metastatic solid tumors.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Multicenter, open-label, first-in-human, Phase 1/2 study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent.
- •Negative blood pregnancy test at screening for women of childbearing potential.
- •Highly effective contraception during the study period and for 6 months after the last study treatment administration for WOCBP, and for male patients who are sexually active with WOCBP. Highly effective contraception methods are defined as: • Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectable, implants, intrauterine devices such as Mirena and nonhormonal intrauterine devices such as ParaGard for WOCBP patients or male patients’ WOCBP partners • Tubal ligation • Vasectomy; In addition to highly effective contraception, participating male patients: • Must use a condom during the study period and for 3 months after the last study treatment administration when engaging in any activity that allows for exposure to ejaculate • Must refrain from donating sperm.
- •Must agree to abstain from donating blood while taking study drug and for 3 months following discontinuation of study treatment.
- •Able to understand the character and individual consequences of clinical trial.
- •Female or male patients, aged at least 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Life expectancy of at least 3 months as assessed by the investigator.
- •Patients with confirmed locally advanced, unresectable, or metastatic solid tumors who have been previously treated with SoC and are no longer eligible for other therapies.
- •Patients who have been treated with an ICI treatment as monotherapy or in combination as SoC.
- •Have recovered from previous treatment.
- •At least 1 measurable lesion according to RECIST Version 1.
- •Adequate hematological, hepatic, and renal functions.
排除标准
- •Patients with central nervous system metastases and/or leptomeningeal carcinomatosis with some exceptions.
- •Any known allergy or severe reaction to any component of anti-CTLA-4 or anti-PD(L)-1 drug product.
- •Significant chronic or acute infections requiring systemic therapy including SARS-CoV-2 (COVID-19) PCR positive testing.
- •Clinically significant active cardiovascular disease.
- •Any other medical conditions or psychological disorders that would increase the safety risk to the patient or interfere with participation of the patient or the evaluation of the clinical study in the opinion of the investigator.
- •Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
- •Patients with active or documented history of autoimmune disease, immune deficiency or syndrome that required systemic corticoids (except the allowed dose) or immunosuppressive medications.
- •Patients who received a previous ICI (like anti-PD(L)-1 or an agent directed to another stimulatory or co-inhibitory T-cell receptor) and were discontinued from that treatment due to toxicity.
- •Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to the first study treatment, with exceptions. Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
- •Patients with history of or current interstitial lung disease or fibrosis, and patients with pneumonitis.
- •Other active malignancy requiring active intervention.
- •Patients with previous malignancies other than the target malignancy to be investigated in this trial, unless a complete remission was achieved and no additional therapy is required during the study period.
- •Patient with any organ transplantation, including allogeneic stem cell transplantation.
- •Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma.
结局指标
主要结局
Dose-limiting toxicities (DLTs) when patients are receiving weekly administration of EGL-001 and proportion of patients with adverse events (AEs), treatment-emergent AEs (TEAEs), and serious AEs (SAEs) between the first dose of study drug and up to 90 days after the last dose of study drug.
Dose-limiting toxicities (DLTs) when patients are receiving weekly administration of EGL-001 and proportion of patients with adverse events (AEs), treatment-emergent AEs (TEAEs), and serious AEs (SAEs) between the first dose of study drug and up to 90 days after the last dose of study drug.
Proportion of patients with complete response (CR) or partial response (PR).
Proportion of patients with complete response (CR) or partial response (PR).
次要结局
- Efficacy assessment based on Overall response rate (ORR), Disease control rate (DCR), Duration of overall response (DoR), Progression-free survival (PFS), Overall survival (OS).
- The proportion of patients with adverse events (AEs), treatment-emergent adverse events (TEAEs), and Serious adverse Events (SAEs) between the first dose of study drug and up to 90 days after the last dose of study drug.
研究者
Pejvack Motlagh
Scientific
Egle Therapeutics