AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 132
- 试验地点
- 165
- 主要终点
- Confirmed Objective Response Rate (ORR) by investigator
研究概览
简要总结
This study is being done to learn more about a new medicine called PF-08634404. It is for adults with a type of bladder cancer called locally advanced or metastatic urothelial cancer (LA/mUC), meaning the cancer has spread to nearby tissues or other parts of the body.
The purpose of the study is to see if PF-08634404 is safe, how well it works, how it moves through the body, and how it affects the cancer. The study will also look at how the medicine may change certain markers in the body that are linked to cancer.
To join the study, participants must:
- Be adults (18 years or older) and
- Have locally advanced or metastatic urothelial cancer,
The study has two groups:
- Cohort A: People who have already received treatment for their cancer will get the study medicine ( PF-08634404) alone.
- Cohort B: People who have not had treatment before will get the study medicine along with another cancer medicine called enfortumab vedotin.
Everyone in the study will get the study medicine through a vein (IV infusion) with or without enfortumab vedotin. Treatment will continue as long as it helps and side effects are manageable.
Before starting, participants will go through a screening period to check if they are eligible. During the study, they will have regular visits for treatment, health checks, and tests to see how the cancer is responding. Scans will be done regularly to monitor the cancer.
If the cancer gets worse but the treatment is still helping and side effects are manageable, participants may be allowed to continue treatment with their doctor's and the sponsor's agreement.
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
- •Age ≥18 years at the time of screening.
- •Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA/mUC).
- •Measurable disease per RECIST v1.1 criteria.
- •ECOG performance status of 0 or
- •Adequate organ function, including hematologic, hepatic, and renal parameters.
- •Willingness to comply with study procedures and provide informed consent.
- •For participants of childbearing potential: agreement to use effective contraception during the study and for a defined period after the last dose.
排除标准
- •Participants will be excluded if they meet any of the following:
- •History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
- •Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
- •Active autoimmune diseases requiring systemic treatment within the past 2 years
- •Participation in another investigational study within 30 days or 5 half-lives of the investigational product.
- •Pregnant or breastfeeding individuals.
- •Inability or unwillingness to comply with study requirements.
- •Study staff or their immediate family members directly involved in the conduct of the study.
研究组 & 干预措施
Cohort A
Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy.
干预措施: PF-08634404 (Biological)
Cohort B
Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin
干预措施: PF-08634404 (Biological)
Cohort B
Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin
干预措施: Enfortumab Vedotin (Biological)
结局指标
主要结局
Confirmed Objective Response Rate (ORR) by investigator
时间窗: Up to approximately 3 years
ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by investigator.
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Through 90 days after the last study intervention; Up to approximately 3 years
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention.
Number of participants with dose limiting toxicity (DLT) in Part 1 of Cohort B
时间窗: Through 90 days after the last study intervention; Up to approximately 3 years
The number of participants who experienced DLTs in participants receiving PF-08634404 in combination with EV.
次要结局
- Duration of Response (DOR) per RECIST v1.1 by investigator(Up to approximately 3 years)
- Progression Free Survival (PFS) per RECIST v1.1 by investigator(Up to approximately 3 years)
- Overall Survival (OS)(Up to approximately 3 years)
- Number of Participants With Clinical Laboratory Abnormalities(Through 90 days after the last study intervention; Up to approximately 3 years)
- Pharmacokinetics (PK): Serum concentration of PF-08634404(Up to 37 days after the last dose of treatment)
- Incidence of Anti-Drug Antibody (ADA) against PF-08634404(Up to 37 days after the last dose of treatment)