A Phase 1 First-in-human, Open-label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-253 in Adult Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 主要终点
- Number of Participants With Adverse Events
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 adverse events, change in disease activity and pharmacokinetics of ABBV-253.
ABBV-253 is an investigational drug being developed for the treatment of advanced solid tumors. This open-label study consists of two parts. In Part 1 (ABBV-253 dose escalation), participants with any of the eligible cancer types will receive 1 of 4 (or more) doses of ABBV-253. Each cohort receives a higher dose, lower dose, or the same dose of ABBV-253 than the previous group. In Part 2 (ABBV-253 dose optimization), a new group of participants with NSCLC will be randomly put into pre-determined dose groups to receive 1 of 3 doses of ABBV-253. Approximately 130 participants will be enrolled in the study at approximately 11 sites worldwide.
Participants will receive intravenous (IV) infusion of ABBV-253, as part of the 4 year study.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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
- •Part 1 monotherapy dose escalation only: Participants with a diagnosis of a malignant solid tumor by histology (WHO criteria), including, but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), PDAC, gastroesophageal adenocarcinoma (GEA), ovarian cancer (OC), and biliary tract cancer (BTC)
- •ECOG performance status of 0 or 1
- •Participants with evaluable and measurable disease per RECIST Version 1.1.
排除标准
- •History of other malignancies, with the following exceptions:
- •No known active disease present within 3 years prior to first dose of study treatment and felt to be at low risk of recurrence by the treating investigator.
- •Adequately treated in situ carcinoma without evidence of disease.
- •Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin without evidence of disease.
- •Participants with ovarian cancer with histologies other than high grade serous ovarian cancer including endometrioid, low grade, clear cell, mucinous, or borderline ovarian tumor.
- •Untreated brain or meningeal metastases (i.e., subjects with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy).
- •History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids or any evidence of ILD or pneumonitis on Screening chest CT scan.
研究组 & 干预措施
Part 1: ABBV-253 Dose Escalation
Participants with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), pancreatic ductal adenocarcinoma cancer (PDAC), gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC) and ovarian cancer (OC) will receive escalating doses of ABBV-253 monotherapy.
干预措施: ABBV-253 (Drug)
Part 2: Dose Optimization - ABBV-253 Dose A
Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose A.
干预措施: ABBV-253 (Drug)
Part 2: Dose Optimization - ABBV-253 Dose B
Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose B.
干预措施: ABBV-253 (Drug)
Part 2: Dose Optimization - ABBV-253 Dose C
Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose C.
干预措施: ABBV-253 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Up to approximately 4 years
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Safety will be evaluated based upon the assessment of all-grade AEs, and SAEs reported during the treatment-emergent period, as well as clinical laboratory parameters (e.g., hematology, chemistry), vital sign measurements, and ECG results.
Number of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results
时间窗: Up to approximately 4 years
Number of participants with abnormal change in clinical laboratory test results like hematology and chemistry will be assessed.
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
时间窗: Up to approximately 4 years
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
时间窗: Up to approximately 4 years
12-lead resting ECG will be recorded.
Objective Response (OR)
时间窗: Up to approximately 4 years
Objective Response (OR) defined as achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigators.
次要结局
- Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-253, ADC, total antibody, and payload(Up to approximately 1 year)
- Time to Maximum Serum/Plasma Concentration (Tmax) of ABBV-253(Up to approximately 1 year)
- Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-253 ADC, total antibody, and payload(Up to approximately 1 year)
- Terminal Half-Life (t1/2) of ABBV-253 ADC, total antibody, and payload(Up to approximately 1 year)
- Incidence of Anti-Drug Antibodies (ADAs)(Up to approximately 1 year)
- Incidence of Neutralizing Antibodies (nAbs)(Up to approximately 1 year)
- Duration of Response (DOR) by Investigator(Up to approximately 4 years)
- Progression-Free Survival (PFS) by Investigator(Up to approximately 4 years)
- Overall Survival (OS)(Up to approximately 4 years)
- Disease Control (DC) by Investigator(Up to approximately 4 years)
- Objective Response (OR) by Blinded Independent Central Review (BICR)(Up to approximately 4 years)
- Duration of Response (DOR) by BICR(Up to approximately 4 years)
- Progression-Free Survival (PFS) by BICR(Up to approximately 4 years)
- Disease Control (DC) by BICR(Up to approximately 4 years)