A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M24D1 for Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
概览
- 阶段
- 1 期
- 干预措施
- BL-M24D1
- 疾病 / 适应症
- 未指定
- 发起方
- Sichuan Baili Pharmaceutical Co., Ltd.
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Phase Ia: Maximum tolerated dose (MTD)
- 状态
- 尚未招募
- 最后更新
- 4个月前
概览
简要总结
This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M24D1 for Injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.
详细描述
The study is divided into two phases: a dose escalation phase (Phase Ia) and a cohort expansion phase (Phase Ib).
研究者
入排标准
入选标准
- •Voluntarily sign the informed consent form and comply with the protocol requirements;
- •No gender restrictions;
- •Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
- •Expected survival time ≥3 months;
- •Locally advanced or metastatic digestive tract tumors and other solid tumors;
- •Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 3 years;
- •Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
- •ECOG performance status score of 0 or 1;
- •Toxicities from prior antitumor treatments have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
排除标准
- •Use of chemotherapy, biological therapy, or immunotherapy within 4 weeks prior to the first dose or within 5 half-lives;
- •History of severe heart disease;
- •QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
- •Active autoimmune or inflammatory diseases;
- •Diagnosis of other malignancies within 5 years prior to the first dose;
- •Hypertension poorly controlled by two antihypertensive medications;
- •Patients with poorly controlled blood glucose;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
- •Lung diseases graded ≥3 according to CTCAE v5.0;
- •Symptoms of active central nervous system metastases;
研究组 & 干预措施
BL-M24D1
Participants receive BL-M24D1 as intravenous infusion for the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: BL-M24D1
结局指标
主要结局
Phase Ia: Maximum tolerated dose (MTD)
时间窗: Up to 28 days after the first dose
MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.
Phase Ia: Dose limiting toxicity (DLT)
时间窗: Up to 28 days after the first dose
DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.
Phase Ib: Recommended Phase II Dose (RP2D)
时间窗: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M24D1.
次要结局
- ADA (anti-drug antibody)(Up to approximately 24 months)
- Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Cmax(Up to approximately 24 months)
- Tmax(Up to approximately 24 months)
- T1/2(Up to approximately 24 months)
- AUC0-t(Up to approximately 24 months)
- CL (Clearance)(Up to approximately 24 months)
- Ctrough(Up to approximately 24 months)
- Phase Ib: Objective Response Rate (ORR)(Up to approximately 24 months)
- Phase Ib: Disease Control Rate (DCR)(Up to approximately 24 months)
- Phase Ib: Duration of Response (DOR)(Up to approximately 24 months)