C6461008 - AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Cohort A: Confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator
研究概览
简要总结
- Cohort A: To determine the antitumor activity of PF-08634404 as monotherapy.
- Cohort A: To characterize the overall safety profile and tolerability of PF-08634404 as monotherapy.
- To evaluate safety and tolerability of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C) (Part 1 only)
- To characterize the overall safety profile and tolerability of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C).
- To evaluate the antitumor activity of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C).
- To identify the optimal dose of PF-08634404 in combination with ipilimumab (Cohort B) and axitinib (Cohort C) (Part 2).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older at screening
- •Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology
- •At least one measurable (as defined by the investigator) and untreated lesion
- •Adequate hematologic, hepatic, cardiac and renal function
- •No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received >12 months prior)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories.
排除标准
- •Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
- •Acute, chronic or symptomatic infections
- •Participants with history of immunodeficiency
- •Clinically significant risk of haemorrhage or fistula
- •History of another malignancy within 3 years
- •History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Active autoimmune diseases requiring systemic treatment within the past 2 years
- •Uncontrolled cardiac and other comorbidities within 6 months prior to the first dose
- •Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study
- •History of severe bleeding tendency or coagulation dysfunction
- •History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose.
研究组 & 干预措施
IPILIMUMAB
干预措施: IPILIMUMAB (Drug)
PF-08634404
干预措施: PF-08634404 (Drug)
AXITINIB, AXITINIB
干预措施: AXITINIB (Drug)
结局指标
主要结局
Cohort A: Confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator
Cohort A: Confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator
Cohort A: Adverse events (AEs) as characterized by type, frequency, intensity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, timing, seriousness, and relationship to study intervention(s)
Cohort A: Adverse events (AEs) as characterized by type, frequency, intensity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, timing, seriousness, and relationship to study intervention(s)
Cohort B/C: Dose limiting toxicities (DLTs) in the first cycle (Part 1)
Cohort B/C: Dose limiting toxicities (DLTs) in the first cycle (Part 1)
Cohort B/C: AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).
Cohort B/C: AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).
Cohort B/C: Confirmed ORR using RECIST 1.1 as assessed by investigator
Cohort B/C: Confirmed ORR using RECIST 1.1 as assessed by investigator
次要结局
- Cohort B/C: Predose and post dose concentrations of PF-08634404
- Cohort B/C: Incidence of ADA against PF-08634404
- Cohort A: - Duration of response (DoR) using RECIST 1.1 as assessed by investigator - Progression-free survival (PFS) using RECIST 1.1 as assessed by investigator - Overall survival (OS)
- Cohort A: Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing
- Cohort A: Predose and post dose concentrations of PF-08634404.
- Cohort A: Incidence of antidrug antibodies (ADA) against PF-08634404
- Cohort B/C: - DoR using RECIST 1.1 as assessed by investigator - PFS using RECIST 1.1 as assessed by investigator - OS
- Cohort B/C: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.