A Phase 1, Open-label Study to Evaluate PF-08046044/SGN-35C in Adults With Advanced Malignancies.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 58
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infection. There are several types of lymphoma. This study will enroll people who have classical Hodgkin lymphoma (cHL), peripheral T cell lymphoma (PTCL), or diffuse large B cell lymphoma (DLBCL).
This clinical trial uses a drug called PF-08046044/SGN-35C . The study drug is in testing and has not been approved for sale. This is the first time SGN -35C will be used in people.
This study will test the safety of SGN-35C in participants with lymphoma. 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 three parts. Parts A and B of the study will find out the best dose and dosing schedule for SGN-35C. Part C will use the dose found in parts A and B to find out how safe SGN-35C is and if it works to treat select lymphomas.
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 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor type
- •For dose escalation and back fill and dose optimization (Parts A and B):
- •Participants with a histologically confirmed lymphoid neoplasm who in the judgement of the investigator have no appropriate standard therapy available at the time of enrollment and are a candidate for PF-08046044/SGN- 35C treatment. Eligible subtypes and treatment status are as follows:
- •Participants with relapsed/refractory (R/R) cHL: should have received at least 3 prior systemic therapies including autologous stem cell transplant [ASCT] (ASCT and the associated high-dose chemotherapy prior to ASCT are considered to be 1 prior line, along with post-transplant consolidation if progression has not occurred between transplant and start of consolidation) or an anti-PD-1 agent (or refused/were ineligible); or 2 prior systemic therapies if, according to the investigator, no other appropriate standard treatment is available.
- •Participants with R/R PTCL (excluding systematic anaplastic large cell lymphoma [sALCL]): should have received at least 2 prior systemic therapies, or 1 prior systemic therapy if, according to the investigator, no other appropriate standard treatment is available.
- •Participants with R/R sALCL: should have received at least 2 prior systemic therapies, including 1 brentuximab vedotin-containing regimen, or 1 prior line of systemic therapy including brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone.
- •Participants with R/R DLBCL: should have received at least 2 prior systemic therapies, including ASCT and chimeric antigen receptor (CAR) T-cell therapy, or were ineligible, or refused.
- •Participants with PTCL and DLBCL must have a detectable cluster of differentiation 30 (CD30) expression level (≥1%) in tumor tissue from the most recent biopsy obtained at or after relapse by local testing.
- •For dose expansion (Part C):
- •Participants are eligible irrespective of CD30 expression on tumor tissue; however, participants must provide tumor tissue for evaluation of CD30 expression from the most recent biopsy obtained at or after relapse.
- •Participants with cHL, PTCL, sALCL, and DLBCL: Eligible subtypes are the same as defined in Parts A and B
- •If activated, the biology cohort may enroll the populations included in Parts A, B, and C.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1
- •Fluorodeoxyglucose positron emission tomography (FDG-PET) avid and bidimensional measurable disease as documented by radiographic technique (spiral computed tomography [CT] preferred)
排除标准
- •Previous exposure to any antibody-drug conjugates (ADCs) with camptothecin-based payload.
- •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 (CNS) disease related to the underlying malignancy. Participants with a history of CNS disease related to the underlying malignancy are allowed if prior CNS disease has been treated and the participant is clinically stable (defined as not currently receiving steroid treatment for symptoms related to cerebral/meningeal disease and with no ongoing related AE).
- •Received previous ASCT infusion <12 weeks prior to the first dose of SGN-35C.
- •Previous allogeneic stem cell transplant (SCT) if they meet any of the following criteria:
- •<100 days from allogeneic SCT. Participants ≥100 days from allogeneic SCT who are stable without immunosuppressive therapy for at least 12 weeks are permitted.
- •Active acute or chronic graft-versus-host disease (GVHD) or receiving immunosuppressive therapy as treatment for or prophylaxis against GVHD.
- •History of clinically significant GI bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of trial treatment.
研究组 & 干预措施
PF-08046044/SGN-35C
PF-08046044/SGN-35C Monotherapy
干预措施: PF-08046044/SGN-35C (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Through 30-37 days after last study treatment, approximately 1 year
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 laboratory abnormalities
时间窗: Through 30-37 days after last study treatment, approximately 1 year
Number of participants with dose modifications due to AEs
时间窗: Up to approximately 1 year
Number of participants with dose-limiting toxicities (DLTs)
时间窗: Up to 21 days
Number of participants with DLTs by dose level
时间窗: Up to 21 days
次要结局
- Number of participants with antidrug antibodies (ADA)(Through 30-37 days after last study treatment, approximately 1 year)
- Maximum concentration (Cmax)(Through 30-37 days after last study treatment, approximately 1 year)
- CR rate as assessed by the investigator(Up to approximately 1 year)
- Area under the concentration time curve (AUC)(Through 30-37 days after last study treatment, approximately 1 year)
- Time at which the maximum concentration occurs (Tmax)(Through 30-37 days after last study treatment, approximately 1 year)
- Apparent terminal half-life (t1/2)(Through 30-37 days after last study treatment, approximately 1 year)
- Trough concentration (Ctrough)(Through 30-37 days after last study treatment, approximately 1 year)
- Objective response rate (ORR) as assessed by the investigator(Up to approximately 1 year)
- Duration of response (DOR)(Up to approximately 1 year)
研究者
Seagen Trial Information Support
Scientific
Seagen Inc.