A Phase 1, Open-Label, Multicenter Study of ADA-011 as Monotherapy and in Combination With a Checkpoint Inhibitor for Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Adanate, Inc
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- Number of Participants Who Experienced an Adverse Event (AE)
研究概览
简要总结
This study consists of dose escalation evaluation to determine the safety and tolerability of ADA-011 as a monotherapy and in combination with a checkpoint inhibitor. Following dose escalation, one or more dose expansion cohorts in selected indications will be explored to further evaluate the safety, tolerability, and preliminary efficacy of ADA-011.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (nonresectable) or recurrent and progressing since the last antitumor therapy and for which no recognized standard therapy exists
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Measurable disease per RECIST v1.1 or per other criteria best suited for the specific tumor type being evaluated
- •Adequate organ function
排除标准
- •Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 2 weeks prior to the first dose of ADA-011
- •Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to the first dose of ADA-011
- •Major trauma or major surgery within 4 weeks prior to the first dose of ADA-011
- •AEs from prior anticancer therapy that have not resolved to Grade ≤1 except for alopecia
- •Known, central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
- •Evidence of active uncontrolled viral, bacterial, or systemic fungal infection
- •Active SARS-CoV-2 infection, irrespective of symptoms.
- •History or risk of severe, chronic, untreated, or currently active autoimmune disease
- •Prior solid organ transplant or has had an allogenic hematopoietic stem cell transplant within the past 20 years
- •Pregnant, lactating, or breastfeeding
研究组 & 干预措施
ADA-011 Monotherapy Dose Escalation
ADA-011 monotherapy will be administered intravenously (IV), every 3 weeks (Q3W) at escalating doses starting with Cycle 1, Day 1, until participant withdrawal. Participants enroll with histologically or cytologically confirmed solid tumors.
干预措施: ADA-011 (Drug)
ADA-011 Monotherapy Dose Expansion
ADA-011 monotherapy with the preliminary recommended phase 2 dose (RP2D) of ADA-011, in participants with histologically or cytologically confirmed solid tumors.
干预措施: ADA-011 (Drug)
Combination Therapy Dose Escalation
Combination therapy with ADA-011 and PD(L)-1 inhibitor (at escalating ADA-011 doses) will be administered IV Q3W, starting with Cycle 1, Day 1 in participants with histologically or cytologically confirmed solid tumors.
干预措施: ADA-011 (Drug)
Combination Therapy Dose Escalation
Combination therapy with ADA-011 and PD(L)-1 inhibitor (at escalating ADA-011 doses) will be administered IV Q3W, starting with Cycle 1, Day 1 in participants with histologically or cytologically confirmed solid tumors.
干预措施: PD(L)-1 inhibitor (Drug)
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event (AE)
时间窗: 36 months
An AE is any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. The number of participants who discontinued study treatment due to an AE will be presented.
Number of Dose-Limiting Toxicities (DLTs)
时间窗: 21 days (cycle 1)
DLTs will be evaluated according to NCI CTCAE v5.0 and are generally defined as grade 3 or higher toxicities which are deemed to be medically significant.
次要结局
- Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (Cmax)(36 months)
- Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (AUC)(36 months)