NL-OMON52379招募中不适用
Phase I/Ib study with the combination of RMC-4630 and LY3214996 in metastatic KRAS mutant CRC, PDAC and NSCLC - The SHERPA-trial - Phase I/Ib study with the combination of RMC-4630 and LY3214996
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 55 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. PART A: Histological or cytological proof of advanced KRASm NSCLC, CRC or
- •PART B: Histological or cytological proof of advanced PDAC.
- •2. Age: 18 years and older;
- •3. Able and willing to give written informed consent;
- •4. WHO performance status of 0, 1
- •5. Able and willing to undergo blood sampling for PK and PD analysis;
- •6. Able and willing to undergo tumor biopsies prior to start (or have undergone
- •a biopsy within 2 months of
- •inclusion), while on study treatment and upon progression of disease;
- •7. Life expectancy > 3 months, allowing adequate follow up of toxicity
- •evaluation and
- •antitumor activity;
- •8. Evaluable disease (PART A and PART B)
- •9. Women of childbearing potential must have an negative serum pregnancy test
- •days prior to registration and agree to use effective contraceptive
- •thoughout the
- •treatment period, and for 4 months after the first of study treatment
- •10. Adequate organ system function
排除标准
- •- Part A: No excluded genotypes
- •- Part B: Excluded genotypes (including co occurring mutations):
- •o NRAS (except G12A/C)
- •o BRAF Class 1, 2, or unclassified
- •- Any treatment with investigational drugs within 30 days prior to receiving
- •the first dose of investigational treatment;
- •- History of another malignancy
- •Exception PART A: Patients who have been disease-free for at least 3
- •years, or patients with a history of completely
- •resected non-melanoma skin cancer and/or patients with indolent completely
- •resected second malignancies are eligible.
- •Exception PART B: Adequately treated carcinoma in situ of the cervix and
- •adequately treated basal cell carcinoma of the
- •- Patients who have had previous treatment with any targeted drug
- •combination known to interfere RAS/MEK/MAPK
- •pathway components.
- •- Woman who are pregnant or breast feeding;
- •- Unreliable contraceptive methods.
- •- Patients who have undergone any major surgery within the last 4 weeks
- •prior to starting study drug or who would not
- •have fully recovered from previous surgery.
- •- Radio- or chemotherapy within the last 4 weeks prior to receiving the
- •first dose of investigational treatment; except a
- •palliative dose of radiation of 8 Gy, which is allowed up to one week
- •before study start and should not be applied to the
- •target lesion.
- •- Patients with cardiac comorbidities, uncontrolled hypertension, prolonged
- •QT interval or patients who have had a stroke
- •within 3 months prior to start study.
- •- Known hypersensitivity to one of the study drugs or excipients.
- •- Baseline diarrhea and/or any condition that would impair absorption of
- •oral agents
- •- Toxicities related to prior treatments > grade 1 (excluding alopecia)
研究者
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