A Phase 1/2, Multicentre, Open-label Clinical Trial of DT-7012 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Selected Advanced Solid Tumors (DOMISOL, DOmain_therapeutics Monoclonal antIbody for SOLid Tumors)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 14
- 主要终点
- Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuation
研究概览
简要总结
This is a phase 1/2, dose-escalation, clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012 (an anti-CCR8 monoclonal antibody) as a single agent and in combination with an immune checkpoint inhibitor in adult participants with selected advanced solid tumors.
详细描述
This is a phase 1/2, first-in-human, multicenter, open-label clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012, administered as monotherapy and in combination with an immune checkpoint inhibitor (ICI), in participants with selected recurrent advanced/metastatic solid tumors.
This study includes:
- a phase 1 Monotherapy Dose Escalation
- a phase 1b Combination Dose Escalation (this part will be initiated upon recommendation from the Safety Review Committee based on Monotherapy Dose Escalation data and corresponds to a dose escalation of a combination of DT-7012 with an ICI)
- a subsequent phase 2 Indication-Specific Efficacy part
The phase 1 aims at determining the maximum tolerated dose or maximum administered dose of DT-7012 as single agent and in combination with an ICI, and the safety and tolerability of DT-7012 as single agent and in combination with an ICI in participants with selected recurrent advanced/metastatic solid tumors.
The phase 2 will assess the efficacy of DT-7012 as monotherapy and/or in combination with an ICI in indication-specific cohorts.
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
- •Histologically or cytologically confirmed solid tumor, among selected cancer types, that is recurrent, locally advanced (i.e., not eligible for curative surgery or radiotherapy) or metastatic, has progressed after at least one line of systemic therapy and has no established curative option.
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the local site investigator/radiologist.
- •At least 1 tumour lesion accessible to biopsy per treating physician judgement.
- •Eastern Cooperative Oncology Group (ECOG) PS of 0 or
- •Adequate organ function.
排除标准
- •Any unresolved AEs from previous anti-cancer therapies of grade ≥2, with the exception of alopecia.
- •Prior severe immune-related AEs (irAEs) leading to immunotherapy treatment discontinuation.
- •Major surgery or significant traumatic injury within 4 weeks prior to Cycle 1 Day 1 with unadequately recovered AEs and/or complications from the intervention prior to Cycle 1 Day
- •Prior radiotherapy within the 4 weeks prior to Cycle 1 Day 1 or limited field palliative radiotherapy within 2 weeks prior to Cycle 1 Day
- •Prior anti-CCR8 monoclonal antibody treatment received in an investigational trial
研究组 & 干预措施
Part 1A
Dose escalation of DT-7012 as a single agent
干预措施: DT-7012 (Drug)
Part 1B
Dose escalation of DT-7012 in combination with an ICI
干预措施: DT-7012 (Drug)
Part 1B
Dose escalation of DT-7012 in combination with an ICI
干预措施: Immune checkpoint inhibitor (Drug)
Phase 2
Evaluation of DT-7012 as a sinle agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts.
干预措施: DT-7012 (Drug)
Phase 2
Evaluation of DT-7012 as a sinle agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts.
干预措施: Immune checkpoint inhibitor (Drug)
结局指标
主要结局
Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuation
时间窗: Cycle 1 (21 days)
Proportion of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and adverse events (AEs) leading to treatment discontinuation
次要结局
- Objective response rate (ORR)(From the first dose of study drug until the date of disease progression/recurrence, assessed up to 12 months)
- Serum concentrations of DT-7012(From the first dose of study drug until the date of end of treatment, assessed up to 12 months)