NCT06399757进行中（未招募）1 期
A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors
Apollo Therapeutics Ltd19 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 19
- 主要终点
- Incidence of Treatment Emergent Adverse Events [Safety]
研究概览
简要总结
This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 for the treatment of selected locally advanced or metastatic solid tumors with particular focus on Colorectal carcinoma (CRC).
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
- •18 years or older
- •Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic tumor; Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma.
- •For Phase 1 sub-studies: Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial Adenocarcinoma, Triple Negative Breast Cancer, Ovarian Cancer, Prostate Cancer
- •Phase 2: Colorectal carcinoma
- •No available standard of care therapy or participant is ineligible for standard of care therapy, except in CRC tumor type in which participant must have previously received all the following therapeutic agents:
- •fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
- •an anti-VEGF therapy
- •if wt-RAS (wt-KRAS and wt-NRAS), an anti-EGFR therapy
- •Eastern Cooperative Oncology Group (ECOG) ≤1
- •Body Weight ≥40 kg.
- •Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse
- •Male participants must be willing to use specific contraception and not plan to impregnate a female partner or donate sperm while on study
- •Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial
排除标准
- •Certain medical conditions such as: active brain metastases, carcinomatous meningitis, unstable angina pectoris, myocardial infarction or clinically significant ventricular arrhythmias, symptomatic congestive heart failure, uncontrolled active infection, history of significant hemorrhage within 4 weeks of the first dose date, intestinal disease or major gastric surgery, arterial thrombosis within 6 months of screening
- •Certain prior therapies such as: anti-cancer treatment within 2 weeks of Cycle 1 Day 1, prior radiotherapy within 14 days before screening, active anti-coagulation therapy, over the counter or prescription medications within 14 days or 5 half-lives prior to cycle 1 day 1, herbal medicines and supplements within 14 days
- •Major surgery within 1 month of screening
- •Hemoglobin < 9.0 g/dL
- •Absolute neutrophil count < 1.5 x 10^9/L
- •Platelet count < 100 x 10^9/L
- •Hepatic function:
- •Aspartate aminotransferase and/or alanine aminotransferase (ALT) >3 × upper limit of normal (ULN) (>5 x ULN for subjects with liver metastases)
- •Total bilirubin >1.5 × ULN (except participants with Gilbert's syndrome).
- •Albumin < 3 g/dL
- •Calculated or measured creatinine clearance of <60 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] × Mass [kg] / [72 × serum creatinine mg/dL]). Multiply result by 0.85 if female.
- •Fridericia's corrected QT interval (QTcF) >470 msec or a family history of Long QT Syndrome.
- •Cardiac function: Echocardiogram (or MUGA) showing Left Ventricular Ejection Fraction (LVEF) <45% at rest
- •Infectious diseases: positive for HIV (unless controlled with active retroviral therapy), hepatitis B and hepatitis C
研究组 & 干预措施
Phase 1: Dose Escalation
Experimental
Dose escalation with increasing dose levels of APL-5125 to identify Recommended Phase 2 Dose.
Possibility to expand into select populations
干预措施: APL-5125 (Drug)
Phase 2: Dose Expansion/Optimization
Experimental
At least 2 dose levels of APL-5125 in a selected population
干预措施: APL-5125 (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events [Safety]
时间窗: Through study completion, approximately one year
Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, electrocardiogram results.
Incidence of dose limiting toxicities [Tolerability] (Phase 1)
时间窗: Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days)
Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs and electrocardiogram results
Determine Recommended Phase 2 Dose (RP2D) levels of APL-5125 in participants with selected advanced solid tumors (Phase 1)
时间窗: Approximately one year
Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)
时间窗: Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)
Response is assessed per RECIST version 1.1 criteria
次要结局
- Incidence of treatment emergent adverse events [Further Safety] (Phase 2)(Through study completion (approximately 2 years))
- Further assess the PK of APL-5125 (Phase 2)(On days 1 and 8 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).)
- Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1)(Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.))
- Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)(On days 1, 2 ,4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).)
- Further assess the anti-tumor activity of APL-5125 (Phase 2)(Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.))
- Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1)(Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.))
- Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)(On days 1, 2 ,4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).)
- Evaluate biomarker(s) in the tumor(Through study completion, approximately one year)
- Further assess the anti-tumor activity of APL-5125 (Phase 2)(Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.))
- Further assess the PK of APL-5125 (Phase 2)(On days 1 and 8 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).)
- Incidence of treatment emergent adverse events [Further Safety] (Phase 2)(Through study completion (approximately 2 years))
- Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)(On days 1, 2, 4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).)
研究者
研究点 (19)
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