A Phase 1b Trial of BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The incidence of dose limiting toxicities (DLTs)
研究概览
简要总结
A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of BOLD-100 in combination with doxorubicin in patients diagnosed with advanced soft tissue sarcomas. The trial is divided into two phases: an initial dose-escalation phase for BOLD-100, followed by a dose-expansion phase based on the recommended dose for Phase 2. In the dose-escalation phase, we plan to enroll 12-15 patients, with an additional 17 patients in the dose-expansion phase.
Participants will receive BOLD-100 intravenously on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin (75 mg/m², intravenous) administered on Day 1 of each 21-day cycle for up to six cycles. Participants will continue to receive BOLD-100 for as long as the cancer is not getting worse, The maximum cycles of doxorubicin are 6 cycles.
Participants will undergo a screening assessment prior to the start treatment to determine eligibility for enrollment. Treatment will commence on Day 1 and will continue until the protocol-defined criteria for treatment withdrawal are met. Disease response will be assessed using CT or MRI scans, starting at 12 weeks after the initiation of treatment and continuing every 12 weeks until withdrawal.
Upon treatment discontinuation or study withdrawal, a post-treatment assessment will be conducted at end of treatment and at 30 days of the last BOLD-100 dose, with follow-up visits scheduled every 3 months thereafter.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BOLD-100 and Doxorubicin Dose Level -1
Escalation phase DL-1 - BOLD-100 230mg/m^2 + Doxorubicin
干预措施: BOLD-100 (Drug)
BOLD-100 and Doxorubicin Dose Level -1
Escalation phase DL-1 - BOLD-100 230mg/m^2 + Doxorubicin
干预措施: Doxorubicin 75 mg/m^2 (Drug)
BOLD-100 and Doxorubicin Dose Level 1
Escalation phase DL1 - BOLD-100 420mg/m^2 + Doxorubicin
干预措施: BOLD-100 (Drug)
BOLD-100 and Doxorubicin Dose Level 1
Escalation phase DL1 - BOLD-100 420mg/m^2 + Doxorubicin
干预措施: Doxorubicin 75 mg/m^2 (Drug)
BOLD-100 and Doxorubicin Dose Level 2
Escalation phase DL2 - BOLD-100 500mg/m^2 + Doxorubicin
干预措施: BOLD-100 (Drug)
BOLD-100 and Doxorubicin Dose Level 2
Escalation phase DL2 - BOLD-100 500mg/m^2 + Doxorubicin
干预措施: Doxorubicin 75 mg/m^2 (Drug)
BOLD-100 and Doxorubicin Dose Level 3
Escalation phase DL3 - BOLD-100 625mg/m^2 + Doxorubicin
干预措施: BOLD-100 (Drug)
BOLD-100 and Doxorubicin Dose Level 3
Escalation phase DL3 - BOLD-100 625mg/m^2 + Doxorubicin
干预措施: Doxorubicin 75 mg/m^2 (Drug)
BOLD-100 and Doxorubicin
Exapsnion: BOLD-100 (RP2D) and Doxorubicin
干预措施: BOLD-100 (Drug)
BOLD-100 and Doxorubicin
Exapsnion: BOLD-100 (RP2D) and Doxorubicin
干预措施: Doxorubicin 75 mg/m^2 (Drug)
结局指标
主要结局
The incidence of dose limiting toxicities (DLTs)
时间窗: Entire duration of Cycle 1 (21 day cycle)
The rate of Adverse Events (AE)
时间窗: time the consent form is signed through 12 months following cessation of treatment
The rate of Adverse Events (AE) characterized by type, frequency, severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Rate of toxicities
时间窗: time the consent form is signed through 12 months following cessation of treatment.
Rate of toxicities as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0, adverse events (AEs), serious AEs (SAEs), dose interruptions and assessment.
Participant Quality of Life
时间窗: pre-dose, Cycle 2 Day1, Cycle 7 Day 1, Cycle 12 Day 1 (21 day cycles)
Assessed using EORTC QLQ-C30 (European Organization For Research And Treatment Of Cancer, Core Quality of Life Questionnaire). With scores from 0 to 100. A high scale score represents a higher response level.
次要结局
- Progression-free survival (PFS)(time the consent form is signed through treatment completion, up to 4-6 weeks after progression if applicable)
- Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100(During Cycle 1 pre-dose, 1hour, 2hours and 48hours post-dose, through Cycle 2 pre-dose (21 day cycles))