NCT05983133终止1 期
A Phase 1 Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 48
- 主要终点
- Number of participants with dose limiting toxicities (DLTs)
研究概览
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.
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
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
- •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.
- •Participants must have unresectable locally advanced or metastatic NSCLC.
- •Prior therapy: Participants must have received platinum-based therapy and at least 1 PD-1/PD-L1 inhibitor. These agents may have been administered either as single agents or in combination. Participants with an activating mutation or rearrangement (eg, EGFR, anaplastic lymphoma kinase [ALK], etc.) must have received available targeted agents if eligible by biomarker status and local standard of care.
- •Participants must have unresectable locally advanced or metastatic HNSCC - non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible.
- •Prior therapy: Participants must have received platinum-based therapy and a PD-1/PD-L1 inhibitor, if eligible by biomarker status and local standard of care. These agents may have been administered either as single agents or in combination.
- •Pancreatic ductal adenocarcinoma (PDAC)
- •Participants must have unresectable locally advanced or metastatic PDAC.
- •Prior therapy: Participants must have received gemcitabine- or FOLFIRINOX-based therapy.
- •Participants should provide archival tumor tissue if available and also agree to biopsies, if medically feasible
- •An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Measurable disease at baseline per RECIST 1.1 criteria.
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
Experimental
PF-08046052/SGN-EGFRd2 monotherapy
干预措施: PF-08046052 (Drug)
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)
研究者
研究点 (48)
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