Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in Gotistobart Trials
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- OncoC4, Inc.
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
This LTE study will examine the long-term overall survival and safety of gotistobart in patients with advanced solid tumors.
详细描述
This is a multi-center, open-label, long term extension study of gotistobart (ONC-392 / BNT316) in participants with advanced or metastatic tumors. The purpose of this trial is to roll over patients who previously enrolled in OncoC4-sponsored gotistobart trials, including those who received gotistobart or gotistobart-based combinations, into an extension trial to collect long-term overall survival and safety data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 yrs old patients who provide written informed consent for the study.
- •Patients must have a confirmed diagnosis of advanced unresectable or metastatic solid tumors treated on the parent gotistobart trials that Sponsor designated as PRESERVE-100 transition-ready.
- •Patients are currently enrolled/randomized and received gotistobart or gotistobart based combination therapy. Patients could be in active treatment or in survival follow up in parent trials.
排除标准
- •Meet any of the study treatment discontinuation criteria specified in the parent study at the time of roll-over in this extension study.
- •Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient.
- •Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this extension study.
- •Permanent discontinuation of gotistobart or combination therapy for any reason during the parent study, or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable). Exception: Participants who permanently discontinued gotistobart from parent studies remain eligible for enrollment in this study if the parent study permitted continued treatment with the combination agent(s) following discontinuation of gotistobart.
- •Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study.
- •Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications.
- •Concurrent participation in any therapeutic clinical trial (other than the parent study).
- •Pregnant, lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment in the parent trial.
研究组 & 干预措施
Cohort B: receive the study treatment specified in the parent trial
Participants enrolling in Cohort B are those who, upon rolling over into this LTE study, are determined to derive clinical benefit from continued study treatment. These participants will continue to receive the study treatment specified in the parent trial, with gotistobart or an gotistobart-based combination, until one of the following occurs.
干预措施: Gotistobart (Drug)
Cohort A: survival follow up period of the parent trial
Participants enrolling in Cohort A of the trial are those who, upon rolling over into this LTE study, are in the survival follow up period of the parent trial. Participants who discontinue study treatment in parent trial should be encouraged to roll over to this LTE for longer survival follow up through periodic clinical visits or telemedicine visits.