A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Tubulis GmbH
- 入组人数
- 250
- 试验地点
- 25
- 主要终点
- Determination of MTD
研究概览
简要总结
The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:
To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.
Participants will:
Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms
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
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
- •Male or non-pregnant, non-breastfeeding female aged 18 years or older
- •Adequate organ function
- •Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1
- •AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade
- •For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.
- •For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D
- •For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D
- •Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.
- •Eastern Cooperative Oncology Group (ECOG) 0-
- •Have a life expectancy of >12 weeks for disease-related mortality, as evaluated by the INV.
- •In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent
- •Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.
- •Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.
排除标准
- 未提供
研究组 & 干预措施
Phase 2: dose optimization in NSCLC and HNSCC
Drug TUB-030, administered by intravenous (IV) infusion NSCLC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion HNSCC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion
干预措施: TUB-030 (Drug)
Phase 1: dose escalation
Drug TUB-030, administered by intravenous (IV) infusion
干预措施: TUB-030 (Drug)
结局指标
主要结局
Determination of MTD
时间窗: From enrollment until 30 days after last study drug
The highest dose is defined at which no more than 1 of 3 patients have had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria
次要结局
- Number of patients with Adverse Events (AE)(From enrollment until 30 days after last study drug)
- Maximum concentration (Cmax)(From enrollment until 30 days after last study drug)
- Trough concentration (Cmin)(From enrollment until 30 days after last study drug)
- The time taken to reach the maximum concentration (Tmax)(From enrollment until 30 days after last study drug)
- Area Under Curve (AUC)(From enrollment until 30 days after last study drug)
- Half life (T1/2)(From enrollment until 30 days after last study drug)
- Determination of immunogenicity(From enrollment until 30 days after last study drug)
- Determination of efficacy(From enrolment until 30 days after last study drug.)