NCT06799533终止1 期
AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 11
- 试验地点
- 21
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
This study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current approved treatment or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. The study will have 3 parts. Part A and B of the study will find out how much PF-08046031 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046031 is safe and if it works to treat solid tumor cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (Open Label)
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
- •Participants in Part 1 (dose escalation) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti programmed death-1 (PD 1)/programmed death-ligand 1 (PD L1) immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
- •Participants in Part 2 (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti PD 1/PD L1 immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) but not more than 2 total prior lines of systemic therapy and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
- •For Part 3 (dose expansion): Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from 1 of the following tumor types: cutaneous melanoma, NSCLC, HNSCC, esophageal cancer.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Measurable disease per RECIST v1.1 at baseline
- •Participants who have refused available standard of care therapies are not eligible.
排除标准
- •Active cerebral/meningeal disease related to the underlying malignancy. Previous exposure to CD228-targeted therapy, vedotin or an MMAE-containing agent, or any taxane containing regimen for advanced disease.
- •Melanoma subtypes including uveal, and mucosal are excluded. Chemotherapy, definitive radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study intervention, or within 2 weeks prior to first dose of study intervention if the underlying disease has progressed on treatment
- •Grade 3 or higher pulmonary disease unrelated to underlying malignancy. Previous history of non-infectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening.
- •Other protocol specific criteria might apply.
研究组 & 干预措施
PF-08046031 monotherapy
Experimental
PF-08046031
干预措施: PF-08046031 (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: through 30 days after the last study treatment; approximately 6 months
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities
时间窗: through 30days after the last study treatment; approximately 6 months
Number of participants with dose limiting toxicities
时间窗: up to 28 days
次要结局
- number of participants with antidrug antibodies(through 30 days after the last study treatment; approximately 6 months)
- Pharmacokinetic (PK) parameter - Area under the curve (AUC)(Through 30 days after the last study treatment; approximately 6 months)
- PK parameter - Maximum Concentration (Cmax)(Through 30 days after the last study treatment; approximately 6 months)
- PK parameter - Time to maximum concentration (Tmax)(Through 30 days after the last study treatment; approximately 6 months)
- PK parameter - Apparent terminal half-life (t1/2)(Through 30 days after the last study treatment; approximately 6 months)
- PK parameter - Trough concentration (Ctrough)(Through 30 days after the last study treatment; approximately 6 months)
- Overall survival (OS)(Approximately 2 years)
- Objective response rate (ORR)(Up to approximately 1 year)
- Duration of response (DOR)(Up to approximately 1 year)
- Progression-free survival (PFS)(Up to approximately 1 year)
研究者
研究点 (21)
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