A Phase 1 Study of HMBD-002-V4C26 (HMBD-002), a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Dose-limiting Toxicity
研究概览
简要总结
This is a phase 1/2, open-label, multi-center, first-in-human, two-stage (Part 1: dose escalation and Part 2: dose expansion) study evaluating multiple doses and schedules of intravenously (IV) administered HMBD-002, with or without pembrolizumab KEYTRUDA®, in patients with advanced solid tumors (i.e., locally advanced and unresectable, or metastatic).
详细描述
This is a phase 1/2, open-label, multi-center study whose principal phase 1 stage objective is to determine the recommended phase 2 dose (RP2D) of the anti-VISTA monoclonal antibody (mAb) as a single agent and combined with the anti-PD-1 mAb pembrolizumab KEYTRUDA® in subjects with advanced solid malignancies.
In the phase 2 stage, the antitumor activity of HMBD-002 alone or combined with pembrolizumab KEYTRUDA® will be evaluated in patients with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC) and a wide range of other malignancies known or documented to express VISTA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 2 - Dose Expansion (Combination Therapy)
HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion in combination with pembrolizumab KEYTRUDA® at the standard labeled dose in patients with TNBC or NSCLC.
干预措施: HMBD-002 (Drug)
Part 1 - Dose Escalation Phase (Monotherapy)
HMBD-002 administered as a 60-minute IV infusion as a monotherapy. HMBD-002 will be administered on Days 1, 8, and 15 of a 21-day cycle.
干预措施: HMBD-002 (Drug)
Part 1 - Dose Escalation Phase (Combination Therapy)
HMBD-002 administered as a 60-minute IV infusion at escalating doses in combination with pembrolizumab KEYTRUDA®. HMBD-002 will be administered on Days 1, 8, and 15 of a 21-day cycle.
The treatment pembrolizumab KEYTRUDA® will be administered as a 30-minute IV infusion at a dose of 200 mg on Day 1 of every 21-day cycle.
干预措施: HMBD-002 (Drug)
Part 1 - Dose Escalation Phase (Combination Therapy)
HMBD-002 administered as a 60-minute IV infusion at escalating doses in combination with pembrolizumab KEYTRUDA®. HMBD-002 will be administered on Days 1, 8, and 15 of a 21-day cycle.
The treatment pembrolizumab KEYTRUDA® will be administered as a 30-minute IV infusion at a dose of 200 mg on Day 1 of every 21-day cycle.
干预措施: Pembrolizumab (Drug)
Part 2 - Dose Expansion (Monotherapy)
HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion as a monotherapy in patients with TNBC or NSCLC.
干预措施: HMBD-002 (Drug)
Part 2 - Dose Expansion (Combination Therapy)
HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion in combination with pembrolizumab KEYTRUDA® at the standard labeled dose in patients with TNBC or NSCLC.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Dose-limiting Toxicity
时间窗: First 21 days of treatment.
The incidence of DLTs during the DLT assessment period.
Frequency and Severity of Adverse Events (AE)
时间窗: Screening to 90 days from last dose.
The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.
Dose-Finding
时间窗: Screening to 90 days from last dose.
Determination of the MTD or maximum tested dose, and the RP2D.
次要结局
- Pharmacokinetics of HMBD-002(Day 1 of dosing through 21 days post last dose.)
- Progression Free Survival (PFS)(Day 1 of dosing through every 90 after the last dose.)
- Duration of Response (DoR)(Day 1 of dosing through every 90 after the last dose.)
- Overall Survival (OS)(Day 1 of dosing through every 90 after the last dose.)
- Objective Response Rate (ORR)(Day 1 of dosing through every 90 after the last dose.)