A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-303, as Monotherapy and in Combination With Budigalimab (ABBV-181), in Adult Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 18
- 主要终点
- Percentage of Participants With Adverse Events (AE)
研究概览
简要总结
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with budigalimab, (ABBV-181).
ABBV-303 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-303 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 181 adult participants will be enrolled in the study across sites worldwide.
In Part A, ABBV-303 will be intravenously (IV) infused in escalating doses as a monotherapy in participants with relapsed (R)/refractory (R) solid tumors, R/R non-small cell lung cancer (NSCLC), R/R renal cell carcinoma (RCC), R/R head and neck squamous cell carcinoma (HNSCC), or R/R tissue agnostic participants with mesenchymal epithelial transition. In Part B, ABBV-303 in combination with budigalimab will be IV infused in participants with R/R solid tumors or NSCLC. The estimated duration of the study is up to 3 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
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
- •Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Laboratory values meeting the protocol's criteria within the screening period (-28 days) prior to the first dose of study drug.
- •Participants with a diagnosis of a malignant solid tumor by histology (World Health Organization [WHO] criteria).
- •Participants with measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
排除标准
- •Unresolved Grade > 1 adverse events (AEs) from prior anti-cancer therapy except for alopecia.
- •Active systemic or uncontrolled local bacterial, fungal, or viral infection requiring antimicrobial therapy.
- •History of hypersensitivity to the active ingredients or any excipients of ABBV-303 and budigalimab (ABBV-181).
- •Body weight < 35 kg.
研究组 & 干预措施
ABBV-303 Dose Escalation: Part 1A Monotherapy
Participants with (R)/refractory (R) solid tumors will receive ABBV-303 in escalating doses as a monotherapy until the maximum tolerable dose (MTD) is determined as part of the 3 year study duration.
干预措施: ABBV-303 (Drug)
ABBV-303 Dose Expansion: Part 2A Monotherapy
Participants with R/R NSCLC will receive ABBV-303 at the recommended phase 1 expansion dose (RP1ED) as a monotherapy as part of the 3 year study duration.
干预措施: ABBV-303 (Drug)
ABBV-303 Dose Expansion: Part 3A Monotherapy
Participants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
干预措施: ABBV-303 (Drug)
ABBV-303 Dose Expansion: Part 4A Monotherapy
Participants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
干预措施: ABBV-303 (Drug)
ABBV-303 Dose Expansion: Part 5A Monotherapy
Tissue agnostic with R/R participants with MET amplification by any commercially available test will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
干预措施: ABBV-303 (Drug)
ABBV-303 Dose Escalation: Part 1B Combination
Participants with R/R solid tumors will receive ABBV-303 in combination with budigalimab at or below the MTD as part of the 3 year study duration.
干预措施: ABBV-303 (Drug)
ABBV-303 Dose Escalation: Part 1B Combination
Participants with R/R solid tumors will receive ABBV-303 in combination with budigalimab at or below the MTD as part of the 3 year study duration.
干预措施: Budigalimab (Drug)
ABBV-303 Dose Expansion: Part 2B Combination
Participants with R/R NSCLC will receive ABBV-303 at or below the MTD in combination with budigalimab as part of the 3 year study duration.
干预措施: ABBV-303 (Drug)
ABBV-303 Dose Expansion: Part 2B Combination
Participants with R/R NSCLC will receive ABBV-303 at or below the MTD in combination with budigalimab as part of the 3 year study duration.
干预措施: Budigalimab (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AE)
时间窗: Up to 3 Years
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
次要结局
- ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST)(Up to 3 Years)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1(Up to 3 Years)
- Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1(Up to 3 Years)
- Progression-free survival (PFS)(Up to 3 Years)
- Overall survival (OS)(Up to 3 Years)