A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SGN-MesoC2 in Subjects With Advanced Solid Tumors
概览
- 阶段
- 1 期
- 干预措施
- PF-08052666
- 疾病 / 适应症
- Carcinoma, Non-Small-Cell Lung
- 发起方
- Seagen, a wholly owned subsidiary of Pfizer
- 入组人数
- 19
- 试验地点
- 21
- 主要终点
- Number of participants with adverse events (AEs)
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.
Patients in this study must have cancer that has come back or did not get better with treatment. Patients must have a solid tumor cancer that can't be treated with standard of care drugs.
This clinical trial uses an experimental drug called PF-08052666/SGN-MesoC2. PF-08052666/SGN-MesoC2 is a type of antibody-drug conjugate (ADC). ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.
This study will have 3 parts. Part A and Part B of the study will find out how much PF-08052666/SGN-MesoC2 should be given to participants. Part C will use the information from Parts A and B to see if PF-08052666/SGN-MesoC2 is safe and if it works to treat solid tumor cancers.
研究者
入排标准
入选标准
- •Aged 18 years or older.
- •Histologically- or cytologically-confirmed metastatic or locally advanced unresectable platinum-resistant ovarian cancer, NSCLC, pancreatic ductal adenocarcinoma, endometrial cancer, colorectal cancer, or mesothelioma, who have relapsed or progressed following standard therapies, or for which no standard therapies are available.
- •An Eastern Cooperative Oncology Group performance status score of 0 or
- •At least 1 measurable lesion at baseline based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- •Archival tumor tissue or a fresh tumor biopsy during the screening period.
- •Adequate hepatic, renal and bone marrow function.
- •Participants must not have received more than 2 lines of cytotoxic systemic therapy in the metastatic setting (Parts B and C only).
排除标准
- •Previously received or currently receiving any systemic anticancer therapy or focal radiotherapy within 4 weeks prior to the first dose of MesoC2 or within 2 weeks prior to the first dose of MesoC2 if the underlying disease had progressed on treatment.
- •Prior anti-MSLN antibody or MSLN-directed ADC (Part C only).
- •Unresolved toxicities from prior therapy greater than NCI CTCAE v5.0 grade 1 at the time of study treatment (except alopecia).
- •Inadequate hepatic dysfunction, renal function, or hematologic abnormalities.
- •Previously untreated brain metastases. Participants who received radiation or surgery for brain metastases are eligible if therapy was completed at least 4 weeks prior to study treatment initiation, and there was no evidence of central nervous system progression nor requirements for chronic corticosteroid therapy
研究组 & 干预措施
PF-08052666
PF-08052666 monotherapy
干预措施: PF-08052666
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Through 30-37 days after the last dose of study treatment, 48 Months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants with dose modifications
时间窗: Up to 4 months
Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions and treatment discontinuations) due to AEs
Number of participants with laboratory abnormalities
时间窗: Through 30-37 days after the last dose of study treatment, 48 Months
Number of participants with dose-limiting toxicities (DLTs)
时间窗: Cycle 1 (21 days)
Incidence of dose-limiting toxicities (DLTs)
次要结局
- Disease control rate (DCR)(Approximately 1 year 4 months)
- Pharmacokinetic (PK) parameter - Area under the serum concentration (AUC)(Cycles 1, 2, and 3 (each cycle is up to 21 days))
- Objective response rate (ORR)(Approximately 1 year 4 months)
- Best response(Approximately 1 year 4 months)
- Overall survival (OS)(Approximately 1 year 4 months)
- Pharmacokinetic (PK) parameter - Maximum serum concentration (Cmax)(Cycles 1, 2, and 3 (each cycle is up to 21 days))
- Duration of response (DOR)(Approximately 1 year 4 months)
- Pharmacokinetic (PK) parameter - Time to reach maximum serum concentration (Tmax)(Cycles 1, 2, and 3 (each cycle is up to 21 days))
- Progression-free survival (PFS)(Approximately 1 year 4 months)
- Pharmacokinetic (PK) parameter - Half-life(Cycles 1, 2, and 3 (each cycle is up to 21 days))
- Number of participants with antidrug antibodies(Cycles 1, 2, and 3 (each cycle is up to 21 days))