A Phase 1a/1b Open Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of DBC-664 in Adult Patients With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- Safety and Tolerability
研究概览
简要总结
DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian cancer, and other advanced solid tumors . This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2). In each part, patients who meet specific eligibility criteria will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Must be ≥18 years of age at the time consent is signed.
- •Has a histologically or cytologically confirmed unresectable recurrent locally advanced or metastatic solid tumor
- •Has measurable disease per RECIST v1.1 (or mRECIST 1.1 for patients with pleural mesothelioma), as assessed by the local site Investigator/radiology.
排除标准
- •Has a diagnosis of immunodeficiency.
- •Has had a prior stem cell, bone marrow, or organ transplant.
- •Has a known history of human immunodeficiency virus (HIV) infection.
- •Has active or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- •Has an active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- •Has a history of (noninfectious) pneumonitis that required steroids or current active pneumonitis/interstitial lung disease.
- •Has symptomatic visceral spread of disease that poses a risk of life-threatening complications in the short term, per Investigator's opinion (including massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated CNS metastases may participate provided they are radiologically stable (ie, without evidence of progression for at least 2 weeks by repeat imaging [note that the repeat imaging should be performed during study Screening]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- •Has a history of a previous secondary malignancy within 3 years of Screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy or other localized, low-grade tumors deemed cured, or whose natural history does not have the potential to interfere with the safety or efficacy assessments of the current study and not treated with systemic anticancer therapy [except hormonal therapy]).
- •Has a known psychiatric or substance abuse disorder that would interfere with the individuals' ability to cooperate with the requirements of the study.
研究组 & 干预措施
Part 1 (Dose Escalation)
Participants will receive DBC-664 to determine the recommended dose for expansion (RDE) regimen.
干预措施: DBC-664 (Biological)
Part 2 (Dose Expansion)
Participants will receive DBC-664 at the RDE as determined in Part 1 of the study to confirm the safety and anti-tumor activity.
干预措施: DBC-664 (Biological)
结局指标
主要结局
Safety and Tolerability
时间窗: 2 years
The safety and tolerability of DBC-664 in patients with solid tumor measured by frequency and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), adverse events of special interest (AESIs), adverse events (AEs) leading to dose interruption and of adverse events (AEs) leading to treatment discontinuation
Determine Recommended Dose for Expansion
时间窗: 1 year
To determine the maximum tolerated dose (MTD) and/or select the recommended dose(s) for expansion (RDE\[s\]) of DBC-664
Characterize Pharmacokinetics
时间窗: 2 years
To characterize the pharmacokinetics (PK) of DBC-664 with Cmax following administration
次要结局
未报告次要终点