A Phase 2, Open-Label, Master Protocol Study to Evaluate Safety and Efficacy of Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Pancreatobiliary Cancers (AndroMETa-118)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 6
- 主要终点
- Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
研究概览
简要总结
Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The pancreas is a gland behind the stomach that produces a digestive fluid that is emptied into the intestines through tube shaped ducts. Pancreatic cancer often starts in these ducts. The goal of this study is to evaluate the safety and efficacy of telisotuzumab adizutecan in combination with gemcitabine and nab-paclitaxel in adult participants with pancreatobiliary cancers.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatobiliary cancers. In Substudy 1, participants will be randomized into two groups. One group will receive different doses of telisotuzumab adizutecan with gemcitabine. The other group will receive standard of care (SOC) - gemcitabine and nab-paclitaxel. Approximately 168 participants will be enrolled in this study in approximately 50 sites worldwide.
Substudy 1 includes a dose escalation stage and a dose optimization stage. In the dose escalation stage, participants will receive escalating doses of Intravenous (IV) telisotuzumab adizutecan + Gemcitabine. In the dose optimization stage, participants will receive 1 of 2 doses of IV telisotuzumab adizutecan with Gemcitabine or SOC. The study will run for a duration of approximately 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or
- •Resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade <= 1 prior to study entry (except for alopecia of any grade).
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
排除标准
- •Prior cellular-Mesenchymal Epithelial Transition (c-MET) protein targeting therapy
- •History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan, including a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug induced pneumonitis, or idiopathic pneumonitis.
- •Has had major surgery or significant traumatic injury within 28 days prior to randomization/enrollment, or anticipation of the need for major surgery during the course of study intervention. Placement of biliary stent/tube is permitted.
研究组 & 干预措施
SS1: Dose Optimization: Standard of Care (SOC)
Participants will receive gemcitabine and nab-paclitaxel as part of the approximately 3 year study duration.
干预措施: Gemcitabine (Drug)
SS1: Dose Optimization: Standard of Care (SOC)
Participants will receive gemcitabine and nab-paclitaxel as part of the approximately 3 year study duration.
干预措施: Nab-Paclitaxel (Drug)
SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine
Participants will receive Telisotuzumab Adizutecan + Gemcitabine until doses for optimization are determined. as part of an approximately 3 year study period.
干预措施: Telisotuzumab Adizutecan (Drug)
SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB
Participants will receive Telisotuzumab Adizutecan Dose B + Gemcitabine as part of the approximately 3 year study duration.
干预措施: Telisotuzumab Adizutecan (Drug)
SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine
Participants will receive Telisotuzumab Adizutecan + Gemcitabine until doses for optimization are determined. as part of an approximately 3 year study period.
干预措施: Gemcitabine (Drug)
SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA
Participants will receive Telisotuzumab Adizutecan Dose A + Gemcitabine as part of the approximately 3 year study duration.
干预措施: Telisotuzumab Adizutecan (Drug)
SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA
Participants will receive Telisotuzumab Adizutecan Dose A + Gemcitabine as part of the approximately 3 year study duration.
干预措施: Gemcitabine (Drug)
SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB
Participants will receive Telisotuzumab Adizutecan Dose B + Gemcitabine as part of the approximately 3 year study duration.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Up to approximately 3 years
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1.
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 3 years
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
- Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1(Up to approximately 3 years)
- Duration Of Response (DoR) assessed by BICR per RECIST v1.1(Up to approximately 3 years)
- Clinical Benefit (CB) assessed by BICR per RECIST v1.1(Up to approximately 3 years)
- Overall Survival (OS)(Up to approximately 3 years)