AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 162
- 试验地点
- 94
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments.
To join in the study, participants must:
- Be 18 years or older
- Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body
The study will look at:
- Whether PF-08634404 is safe to use with other cancer medicines.
- What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease.
- Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors.
The study has different parts, each testing PF-08634404 with a different cancer medicine:
- Part A will test PF-08634404 with a medicine called sigvotatug vedotin.
- Part B will test PF-08634404 with a medicine called PF-08046054/SGN-PDL1V
Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.
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
- •Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
- •PD-L1 status available
- •Part B only: PD-L1 ≥ TPS 1%
- •Measurable disease based on RECIST v1.1 per investigator.
- •Eastern Cooperative Oncology Group performance status of 0 or
- •Adequate organ function
排除标准
- •Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)
- •History of another malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
- •Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
- •Leptomeningeal disease
- •Active autoimmune diseases requiring systemic treatment within the past 2 years
- •Previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC
- •Previous treatment with immunotherapy (exception is (neo)adjuvant or consolidation anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy >30 Gy to the lung within 6 months of first dose of study intervention
研究组 & 干预措施
PF-08634404 + Sigvotatug Vedotin (Part A)
Participants will receive PF-08634404 in combination with Sigvotatug Vedotin.
干预措施: PF-08634404 (Biological)
PF-08634404 + PF-08046054/SGN-PDL1V (Part B)
Participants will receive PF-08634404 in combination with other anticancer agents as per protocol.
干预措施: PF-08634404 (Biological)
PF-08634404 + PF-08046054/SGN-PDL1V (Part B)
Participants will receive PF-08634404 in combination with other anticancer agents as per protocol.
干预措施: PF-08046054/SGN-PDL1V (Biological)
PF-08634404 + Sigvotatug Vedotin (Part A)
Participants will receive PF-08634404 in combination with Sigvotatug Vedotin.
干预措施: Sigvotatug Vedotin (Biological)
结局指标
主要结局
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 5 years
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Phase I: Number of participants with dose limiting toxicity (DLT)
时间窗: Through 90 days after the last study intervention; Up to approximately 5 years
Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.
Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator
时间窗: Up to approximately 5 Years
ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1.
次要结局
- Disease Control Rate (DCR) per RECIST v1.1 by investigator(Up to approximately 5 years)
- Phase I: Confirmed ORR per RECIST v1.1 by investigator(Up to approximately 5 Years)
- Duration of Response (DOR) per RECIST v1.1 by investigator(Up to approximately 5 years)
- Progression Free Survival (PFS) per RECIST v1.1 by investigator(Up to approximately 5 years)
- Number of Participants With Clinical Laboratory Abnormalities(Through 90 days after the last study intervention; Up to approximately 5 years)
- Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents(Up to 37 days after the last dose of treatment)
- Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents(Up to 37 days after the last dose of treatment)