NCT07755436招募中1 期
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Antitumor Activity of ARR-002 in Adults With Locally Advanced or Metastatic Ovarian or Endometrial Cancer.
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
- 180
- 试验地点
- 6
- 主要终点
- Treatment-Emergent Adverse Event (TEAE)
研究概览
简要总结
This is a Phase 1 study to assess safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ARR-002 in advanced or metastatic ovarian or endometrial cancer.
详细描述
This is an open-label, multicenter Phase 1a/1b dose-escalation/expansion, consecutive-cohort, to assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of ARR-002 in adults with locally advanced or metastatic ovarian or endometrial cancer.
The study will consist of 2 main parts:
- Phase 1a will enroll participants with platinum-resistant ovarian cancer (PROC). This dose-escalation portion will assess the safety and tolerability of ARR-002.
- Phase 1b will enroll cohorts of participants by cancer type; platinum-resistant ovarian cancer (PROC) and endometrial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically and cytologically confirmed advanced or metastatic ovarian, primary peritoneal, or fallopian tube cancer, and platinum resistant who have failed or intolerant to standard therapy, or without alternative standard therapy.
- •Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •Tumor specimen available for testing, or agree to biopsy at baseline.
- •The score of Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy ≥ 12 weeks.
- •Organ functions and coagulation function must meet the basic requirements.
- •Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
排除标准
- •Prior treatment with auristatin-derived drugs s (eg, MMAE and monomethyl auristatin F [MMAF]).
- •Received antitumor therapy within 4 weeks prior to the first dose or 5 half-lives, whichever is shorter.
- •Infection of active hepatitis B, active hepatitis C, or HIV.
- •Symptomatic Central nervous system and/or meninges metastasis.
- •History of uncontrolled diabetes mellitus or diabetic neuropathy within 3 months before the first dose of study treatment.
- •Previous drug-induced interstitial lung disease (ILD) or active ILD.
- •Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion.
- •History of recurrent gastrointestinal (GI) obstruction.
- •Patients with more than one cancer.
- •Any other diseases, pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding
- •Grade ≥ 2 peripheral neuropathy
- •History of severe cardiovascular diseases.
- •Current use of anticoagulants or thrombolytic agents for therapeutic purposes.
- •Known allergic reactions to any component of ARR-
- •Prior treatment with MUC16- or NaPi2b-targeting agents.
- •Ocular conditions such as keratitis or corneal ulceration, monocularity, corneal transplantation, uncontrolled retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disorder.
- •Other situations that are not suitable to participate a clinical trial per investigator's judgement.
研究组 & 干预措施
ARR-002
Experimental
干预措施: ARR-002 (Drug)
结局指标
主要结局
Treatment-Emergent Adverse Event (TEAE)
时间窗: Baseline to 30 days after the last dose of study treatment
AEs that occur or worsen on or after the first dose of study treatment
Maximum Tolerated Dose (MTD)
时间窗: Baseline to Day 21 of the first treatment cycle
Incidence of dose-limiting toxicities (DLTs) and serious adverse events (SAEs)
次要结局
- Incidence of anti-drug antibody (ADA)(Baseline to 30 days after the last dose.)
- Objective Response Rate (ORR) - Phase Ia(Baseline to study completion (up to 24 months))
- Duration of Response (DOR)(Baseline to study completion (up to 24 months))
- Disease Control Rate (DCR)(Baseline to study completion (up to 24 months))
- Progression Free Survival (PFS) as assessed by investigator(Baseline to study completion (up to 24 months))
- Overall Survival (OS)(Baseline to study completion (up to 24 months))
研究者
研究点 (6)
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