First-In-Human, Open-Label, Dose Escalation and Expansion Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of GEN1106 in Participants With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Genmab
- 入组人数
- 103
- 试验地点
- 10
- 主要终点
- Part 3 Expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
研究概览
简要总结
The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with certain types of cancer.
The trial has multiple parts. The first part of the trial tests different doses of GEN1106 to find out if it is safe and determine what are the best doses to use. The second and third parts continues to test the safety of and how well GEN1106 works in additional participants with a specific cancer type and at doses chosen based on results from the first part of the trial.
For each participant, the trial will last approximately 17 months but will vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 5 months of treatment (the duration of treatment may vary for each participant), and approximately 11 months of follow up after trial treatment ends (the duration of follow up may vary for each participant).
Participation in the trial will require visits to the site, with more frequent visits during the first 6 weeks of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography [CT] scans) to monitor whether the treatment is safe and effective.
All participants will receive active drug; no one will be given placebo.
详细描述
This is a first-in-human (FIH), open-label, multicenter, dose escalation and expansion trial in participants with urothelial and other cancers who have metastatic disease to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of GEN1106.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomization will not be used for the Dose Escalation part. In the Dose Refinement and Expansion parts, randomization may be used.
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
- •Have received and progressed on, been intolerant to, or be ineligible for all available standard of care (SoC) therapies known to provide a survival and/or quality of life benefit for their tumor type. These therapies should include chemotherapy, anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapies, enfortumab vedotin (EV), and other therapies, where applicable.
- •Have measurable disease according to RECIST v1.
- •Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening.
- •Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol.
- •Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC).
排除标准
- •Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy.
- •Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.
- •Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade
- •Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
研究组 & 干预措施
Part 2: Dose Refinement
Groups of participants will receive up to 3 dose levels of GEN1106 based on the dose escalation data.
干预措施: GEN1106 (Biological)
Part 3: Dose Expansion
Participants will receive up to 2 dose levels of GEN1106 based on the dose escalation / dose refinement data.
干预措施: GEN1106 (Biological)
Part 1: Dose Escalation
Groups of participants will receive 1 of 4 escalating dose levels of GEN1106.
干预措施: GEN1106 (Biological)
结局指标
主要结局
Part 3 Expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Up to approximately 16 months
Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)
时间窗: 21 days
Part 1 Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to approximately 16 months
Part 2 Dose Refinement: Number of Participants with AEs and SAEs
时间窗: Up to approximately 16 months
次要结局
- Part 3 Expansion: Number of Participants with AEs and SAEs(Up to approximately 16 months)
- Part 1 Dose Escalation and Part 2 Dose Refinement: Number of Participants with Antidrug Antibodies (ADA) to GEN1106(Up to approximately 5 months)
- Part 3 Expansion: Number of Participants with ADA to GEN1106(Up to approximately 5 months)
- Part 1 Dose Escalation and Part 2 Dose Refinement: Plasma Concentrations of GEN1106-related Analytes(Up to approximately 5 months)
- Part 3 Expansion: Plasma Concentrations of GEN1106-related Analytes(Up to approximately 5 months)
- Part 1 Dose Escalation and Part 2 Dose Refinement: Disease Control Rate (DCR) per RECIST v1.1(Up to approximately 16 months)
- Part 3 Expansion: DCR per RECIST v1.1(Up to approximately 16 months)
- Part 1 Dose Escalation and Part 2 Dose Refinement: Duration of Response (DOR) per RECIST v1.1(Up to approximately 16 months)
- Part 3 Expansion: DOR per RECIST v1.1(Up to approximately 16 months)
- Part 1 Dose Escalation and Part 2 Dose Refinement: Time to Response (TTR) per RECIST v1.1(Up to approximately 16 months)
- Part 3 Expansion: TTR per RECIST v1.1(Up to approximately 16 months)
- Part 1 Dose Escalation and Part 2 Dose Refinement: ORR per RECIST v1.1(Up to approximately 16 months)