A Phase 1 Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors

Seagen, a wholly owned subsidiary of Pfizer24 个研究点分布在 2 个国家目标入组 65 人2023年11月14日

适应症Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung Squamous Cell Carcinoma of the Head and Neck Pancreatic Ductal Adenocarcinoma

干预措施PF-08046052

概览

阶段: 1 期
干预措施: PF-08046052
疾病 / 适应症: Colorectal Neoplasms
发起方: Seagen, a wholly owned subsidiary of Pfizer
入组人数: 65
试验地点: 24
主要终点: Number of participants with dose limiting toxicities (DLTs)
状态: 进行中（未招募）
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

概览

简要总结

This study will test the safety of a drug called PF-08046052/SGN-EGFRd2 in participants with advanced solid tumors. 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.

Participants will have cancer that cannot be removed (unresectable) or has spread through the body (metastatic).

This study will have three parts. Parts A and B of the study will find out how much PF-08046052/SGN-EGFRd2 should be given to participants. Part C will use the dose found in parts A and B to find out how safe PF-08046052/SGN-EGFRd2 is and if it works to treat solid tumor cancers.

注册库

clinicaltrials.gov

开始日期

2023年11月14日

结束日期

2026年8月14日

最后更新

3个月前

研究类型

Interventional

研究设计

Sequential

性别

All

研究者

发起方

Seagen, a wholly owned subsidiary of Pfizer

责任方

Sponsor

入排标准

入选标准

•Tumor types:
•For Part A: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment. Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from one of the following tumor types:
•Colorectal cancer (CRC)
•Non-small cell lung cancer (NSCLC)
•Head and neck squamous cell cancer (HNSCC)-non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible.
•For Part B: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment.
•The tumor type(s) to be enrolled in dose optimization will be identified by the sponsor from among those specified in Part A.
•For Part C: Participants must have disease that is relapsed or refractory or be intolerant to standard of care therapies as specified below, unless contraindicated:
•Participants must have unresectable locally advanced or metastatic CRC.
•Prior therapy: Participants must have received prior fluoropyrimidine, oxaliplatin and irinotecan. Participants with defective mismatch repair and microsatellite instability high (dMMR/MSI-H) should have received prior treatment with pembrolizumab, a nivolumab-containing regimen, or other available anti-PD-1 (programmed cell death protein 1) or anti PD L1 (programmed cell death 1 ligand) agents.

排除标准

•History of another malignancy within 3 years before the first dose of study treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
•Known active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are
•clinically stable for at least 4 weeks prior to study entry after brain metastases treatment,
•they have no new or enlarging brain metastases,
•and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug.
•Treatment with an aminobisphosphonate IV (eg ibandronate, pamidronate, zoledronate, etc.) within 4 weeks of the first dose of study treatment.
•Participants with history of thromboembolic phenomena within 6 months prior to the first dose of study intervention, or with contraindication to thromboembolism prophylaxis (if clinically indicated) for a previous history of thrombus.

研究组 & 干预措施

PF-08046052/SGN-EGFRd2

PF-08046052/SGN-EGFRd2 monotherapy

干预措施: PF-08046052

结局指标

主要结局

Number of participants with dose limiting toxicities (DLTs)

时间窗: Up to 35 days

Number of participants with laboratory abnormalities

时间窗: Through 30-37 days after last study treatment, up to approximately 1 year

Number of participants with adverse events (AEs)

时间窗: Through 90 days after last study treatment, up to approximately 1 year

An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention

Number of participants with DLTs by dose level

时间窗: Up to 35 days

次要结局

PK parameter - Time to maximum concentration (Tmax)(Through 30-37 days after last study treatment, up to approximately 1 year)
Number of participants with antidrug antibodies (ADAs)(Through 30-37 days after last study treatment, up to approximately 1 year)
PK parameter - Apparent terminal half-life (t1/2)(Through 30-37 days after last study treatment, up to approximately 1 year)
Pharmacokinetic (PK) parameter - Area under the curve (AUC)(Through 30-37 days after last study treatment, up to approximately 1 year)
PK parameter - Trough concentration (Ctrough)(Through 30-37 days after last study treatment, up to approximately 1 year)
Progression-free survival (PFS)(Up to approximately 2 years)
PK parameter - Maximum concentration (Cmax)(Through 30-37 days after last study treatment, up to approximately 1 year)
Objective response rate (ORR)(Up to approximately 2 years)
Duration of response (DOR)(Up to approximately 2 years)
Overall survival (OS)(Up to approximately 3 years)