NCT06287463终止1 期
A Master Protocol for the Multi-Cohort, Open-Label, Phase 1/2 Study of DCC-3084 as Monotherapy and in Combination With Other Antitumor Agents in Participants With Advanced Malignancies Driven by the MAPK Pathway
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 18
- 主要终点
- Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)
研究概览
简要总结
This is a multicenter clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with advanced/metastatic solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion).
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
- •General Inclusion Criteria ModA Part 1 and 2:
- •Able to take oral medication
- •If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements
- •Adequate organ function and electrolytes
- •Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 to 1 at Screening
- •Has a life expectancy of more than 6 months
- •In addition to these general inclusion criteria, participants must meet all the module cohort-specific inclusion criteria
- •Inclusion Criteria ModA Part 1 Cohort Specific:
- •Pathologically confirmed diagnosis of solid cancer and documentation of Kirsten rat sarcoma (KRAS), Harvey rat sarcoma virus (HRAS), neuroblastoma ras viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), v-raf murine sarcoma viral oncogene homolog C1(CRAF), and/or neurofibromatosis 1 (NF1) mutation
- •Have exhausted all available standard of care therapies that are known to provide benefit for the participant's condition, as judged by the Investigator
- •Inclusion Criteria ModA Part 2 Cohort Specific:
- •Documented BRAF gene mutation
- •Pathologically confirmed diagnosis with PD after at least one prior line of therapy in the advanced or metastatic setting
排除标准
- •General Exclusion Criteria ModA Part 1 and 2:
- •Prior treatment with certain BRAF dimer inhibitors
- •Female participant is pregnant or lactating
- •Received any prior or concurrent medications or therapies known to be prohibited with DCC-3084 within 14 days
- •Received any prior antitumor therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-3084
- •Known allergy or hypersensitivity to any component of the study drug
- •Invasive malignancy within 2 years prior to the first dose of study drug other than the study indication or specific types of cancer treated with curative intent
- •Have not recovered from all clinically relevant toxicities from prior therapy
- •Impaired cardiac function
- •History of recent thrombotic or embolic events
- •Malabsorption syndrome or other illness that could affect oral absorption
- •Major surgery within 28 days of the first dose of study drug
- •In addition to the general exclusion criteria, participants will also be excluded based on the cohort-specific exclusion criteria
- •Exclusion Criteria: Module A Part 2 Cohort Specific:
- •Has known co-occurring mutation of KRAS, HRAS, NRAS, NF1, epidermal growth factor receptor, Phosphoinositide-3-kinase, catalytic, alpha polypeptide (PI3KCA), or Phosphatase and TENsin homolog deleted on chromosome 10 (PTEN)
研究组 & 干预措施
DCC-3084 Module A Escalation Phase (ModA Part 1)
Experimental
Participants will receive DCC-3084 in ModA Part 1, Escalation Phase.
干预措施: DCC-3084 (Drug)
DCC-3084 Module A Expansion Phase (ModA Part 2)
Experimental
Participants will receive DCC-3084 in ModA Part 2, Expansion Phase. Trial terminated prior to start of ModA Part 2.
干预措施: DCC-3084 (Drug)
结局指标
主要结局
Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)
时间窗: Cycle 1 (28 days)
DLTs reported during ModA Part 1.
Objective Response Rate (ORR) (ModA Part 2)
时间窗: Start of Therapy to Progressive Disease (PD), Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol.
次要结局
- ORR (ModA Part 1)(Start of Therapy to PD, Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months))
- Overall Survival (OS) (ModA Part 1 and 2)(Start of Therapy to Death Due to Any Cause (Estimated up to 36 months))
- Progression-Free Survival (PFS) (ModA Part 1 and 2)(Start of Therapy to PD or Death Due to Any Cause (Estimated up to 24 months))
- Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2)(Predose up to 12 hours postdose)
研究者
研究点 (18)
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