A Phase 1 Dose Finding and Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option in Subjects With Metastatic Solid Tumors
概览
- 阶段
- 1 期
- 干预措施
- GEN1042
- 疾病 / 适应症
- Non-CNS Tumor
- 发起方
- Genmab
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
- 状态
- 终止
- 最后更新
- 2个月前
概览
简要总结
The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.
详细描述
The study will be conducted in two parts: Part 1 (dose-finding) and Part 2 (randomization). Part 1 will evaluate the safety of immunoradiotherapy combinations and establish the dose(s) to be evaluated in Part 2. Part 2 will evaluate the anti-tumor activity of immunoradiotherapy combinations at the established dose(s) from Part 1. Participants in both parts are treated with one of the following combinations: * Radiotherapy + GEN1042 * Radiotherapy + GEN1042 + Pembrolizumab While participants in Part 1 are assigned sequentially (GEN1042 without pembrolizumab is investigated first), participants in Part 2 are randomized 1:1 in the two treatment arms.
研究者
入排标准
入选标准
- •Participants with histologically confirmed non-central nervous system (CNS) solid tumor that is metastatic and for whom there is no available standard therapy.
- •At least 18 years of age.
- •Signed informed consent prior to any screening procedures.
- •Measurable disease according to RECIST v1.
- •Life expectancy of \>3 months.
- •Qualify for palliative radiotherapy as an available option for disease management.
- •Eastern Cooperative Oncology Group (ECOG) 0-
- •Normal or adequate liver, renal, cardiac and bone marrow function.
排除标准
- •Prior malignancy except for non-melanoma skin cancers and in situ cancers.
- •Condition contraindicating radiotherapy.
- •Rapidly progressing disease.
- •Active, known or suspected autoimmune disease.
- •History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
- •Contraindications to the use of pembrolizumab.
- •Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment.
- •Received an allogeneic tissue/solid organ transplant.
- •Active infection requiring systemic therapy.
- •Note: Other protocol defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Radiotherapy + GEN1042
干预措施: GEN1042
Radiotherapy + GEN1042
干预措施: Radiotherapy
Radiotherapy + GEN1042 + Pembrolizumab
干预措施: GEN1042
Radiotherapy + GEN1042 + Pembrolizumab
干预措施: Pembrolizumab
Radiotherapy + GEN1042 + Pembrolizumab
干预措施: Radiotherapy
结局指标
主要结局
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
时间窗: During the first cycle (Cycle length = 21 days)
Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
Part 2: Number of Participants with Abscopal Response in Non-irradiated Target Lesions
时间窗: Up to 12 months after the last radiation treatment
Assessed by investigator.
次要结局
- Parts 1 and 2: Objective Response Rate (ORR)(Up to 2 years)
- Parts 1 and 2: Duration of Response (DOR)(Up to 2 years)
- Parts 1 and 2: Disease Control Rate (DCR)(Up to 2 years)
- Parts 1 and 2: Progression Free Survival (PFS)(Up to 2 years)
- Parts 1 and 2: One- year Overall Survival (OS)(Up to 2 years)
- Part 1: Number of Participants With Abscopal Response in Non-irradiated Target Lesions(Up to 12 months after the last radiation treatment)
- Parts 1 and 2: Number of Participants with Adverse Events (AEs)(From screening until the end of the safety follow-up period (30 days or 90 days after last dose))
- Parts 1 and 2: Number of Participants with Anti-drug Antibodies (ADAs)(Predose at multiple timepoints up to 30 days after last dose)
- Parts 1 and 2: Plasma Concentration of GEN1042(Predose and postdose at multiple timepoints up to 30 days after last dose)