A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
概览
- 阶段
- 1 期
- 干预措施
- PF-08046049
- 疾病 / 适应症
- Cutaneous Melanoma
- 发起方
- Seagen, a wholly owned subsidiary of Pfizer
- 入组人数
- 41
- 试验地点
- 65
- 主要终点
- Number of participants with dose limiting toxicities
- 状态
- 进行中（未招募）
- 最后更新
- 12天前
概览
简要总结
This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat 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.
This study will have 3 parts. Parts A and B of the study will find out how much PF-08046049/SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046049/SGN-BB228 is safe and if it works to treat solid tumor cancers.
研究者
入排标准
入选标准
- •All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy.
- •Participants must have one of the following tumor types:
- •Parts A and B: Participants must have metastatic or unresectable cutaneous melanoma.
- •Part C: Participants must have one of the following tumor types:
- •Cutaneous Melanoma
- •Non-small Cell Lung Cancer (NSCLC)
- •Colorectal Cancer (CRC)
- •Pancreatic Cancer
- •Mesothelioma
- •A pre-treatment biopsy or submission of archival tissue is required
排除标准
- •History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- •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 metastasis 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.
- •Prior therapies cannot include any drugs targeting CD228 or 4-1BB
- •Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment
- •Melanoma subtypes including acral, uveal, and mucosal are excluded
研究组 & 干预措施
PF-08046049
PF-08046049 monotherapy
干预措施: PF-08046049
结局指标
主要结局
Number of participants with dose limiting toxicities
时间窗: Up to 28 days
Number of participants with laboratory abnormalities
时间窗: Through 30 days after the last study treatment; approximately 7 months
Number of participants with adverse events (AEs)
时间窗: Through 30 days after the last study treatment; approximately 7 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.
次要结局
- Objective response rate (ORR)(Up to approximately 1 year)
- Pharmacokinetic (PK) parameter - Area under the curve (AUC)(Through 30 days after the last study treatment; approximately 7 months)
- Number of participants with antidrug antibodies(Through 30 days after the last study treatment; approximately 7 months)
- Duration of response (DOR)(Up to approximately 1 year)
- PK parameter - Time to maximum concentration (Tmax)(Through 30 days after the last study treatment; approximately 7 months)
- PK parameter - Apparent terminal half-life (t1/2)(Through 30 days after the last study treatment; approximately 7 months)
- PK parameter - Trough concentration (Ctrough)(Through 30 days after the last study treatment; approximately 7 months)
- Overall survival (OS)(Approximately 2 years)
- Progression-free survival (PFS)(Up to approximately 1 year)
- PK parameter - Maximum Concentration (Cmax)(Through 30 days after the last study treatment; approximately 7 months)