A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 15
- 主要终点
- Phase 1b: Percentage of participants experiencing Adverse Events
研究概览
简要总结
Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with Metastatic Pancreatic Cancer Disease treated with Intravenous (IV) infusion of modified FOLFIRINOX (mFFX) combined with IV infusions of ABBV-927 with or without Budigalimab.
ABBV-927 and Budigalimab are the investigational drugs being developed for treatment of Metastatic Pancreatic Cancer Disease. In this study, doctors will enroll participants between 18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed with Metastatic Pancreatic Cancer Disease in 4 different groups, called treatment arms. Each group will receive different treatments. Approximately 129 adult participants will be enrolled in the study across approximately 27 sites worldwide.
Participants will receive ABBV-927 and Budigalimab as Intravenous (IV) Infusion in Phase 1b on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b on Day1 and Day 15 of every 28 day cycle up to maximum of 2 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. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
详细描述
Study study was terminated before the Phase 2 portion of the study began.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight >= 35 kg.
- •Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
- •Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1).
- •Prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable.
排除标准
- •Participants with locally advanced disease.
- •Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
- •Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma.
- •Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months.
- •Prior radiotherapy to any measurable metastatic lesion at any time.
- •Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion).
- •Known metastases to the central nervous system (CNS).
研究组 & 干预措施
Phase 1b Dose Escalation
Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab.
干预措施: ABBV-927 (Drug)
Phase 1b Dose Escalation
Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab.
干预措施: Budiglimab (Drug)
Phase 1b Dose Escalation
Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab.
干预措施: modified FOLFIRINOX (Drug)
结局指标
主要结局
Phase 1b: Percentage of participants experiencing Adverse Events
时间窗: Up to 6 months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and 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 as either probably related, possibly related, probably not related or not related.
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values
时间窗: Up to 6 months
Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for laboratory data as applicable. If more than one measurement exists for a participant on a particular day and time, an arithmetic average will be calculated. This average will be that participant's measurement for that day. For participants that do not have any post-baseline measurements, only their baseline values will be summarized.
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs
时间窗: Up to 6 months
Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for vital signs data.
Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT)
时间窗: Up to 6 months
A DLT is defined as any serious AE for which a clear alternative cause cannot be established (e.g., attributed to the disease under study, another disease, or to a concomitant medication \[e.g., COVID-19 vaccine\] by the investigator or AbbVie Therapeutic Area (TA) MD\] that occurs during the DLT observation period, and is not listed as a predefined exception in the protocol.
次要结局
- Phase 1b: Maximum Plasma Concentration (Cmax)(Up to approximately 3 months)
- Phase 1b: Time to Maximum Observed Plasma Concentration (Tmax)(Up to approximately 3 months)
- Phase 1b: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma(Up to approximately 3 months.)
- Phase 1b: Objective Response Rate (ORR)(Up to approximately 27 months)
- Phase 1b: Clinical Benefit Rate (CBR)(Up to approximately 27 months)
- Phase 1b: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR(Up to approximately 27 months)
- Phase 1b: Progression Free Survival (PFS)(Up to approximately 24 months after study drug discontinuation)
- Phase 1b: Quality of Life(QoL)-Measure Participant Overall Perceptions of Their Change in Pancreatic Cancer Symptoms includes the Patient Global Impression of Severity (PGIS) and the the Patient Global Impression of Change (PGIC)(Up to approximately 25 months)