NL-OMON37039尚未招募不适用
A Phase 1 Study to Evaluate the Safety, Tolerability and Efficacy of MK-8353 Combination Therapies in Subjects With Advanced Solid Tumors - MK8353-010
Merck Sharp & Dohme (MSD)0 个研究点目标入组 24 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
- 尚未招募
- 发起方
- 入组人数
- 24
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. Be willing and able to provide written informed consent for the trial.
- •2. Have one of the following pathologically/histologically confirmed cancer types to be
- •eligible for each study arm:;a. Arm A: metastatic CRC with a KRAS mutation in their tumor sample,
- •progressed during or within 6 months of the last dose of a prior chemotherapy,
- •and FOLFIRI treatment is indicated in the opinion of the investigator;;•* Subjects must agree to provide archival tumor tissue sample or newly
- •obtained tumor biopsy sample if archived tissue is unavailable for
- •analysis of KRAS mutation to determine eligibility.;b. Arms B & C: any advanced solid tumor (metastatic or locally advanced
- •disease) that has failed to respond to curative therapy, progressed despite
- •curative therapy, or for which curative therapy is not available.;•* For Arm C: a subset of subjects enrolled at the maximum tolerated
- •dose (MTD) must have either NRAS/BRAF mutant melanoma or
- •KRAS mutant NSCLC. In this subset, subjects must agree to provide
- •archival tumor tissue sample or newly obtained tumor biopsy sample if
- •archived tissue is unavailable for analysis of KRAS/NRAS/BRAF
- •mutation to determine eligibility.;3. Have at least one measurable lesion, as defined by Response Evaluation Criteria in
- •Solid Tumors (RECIST v1.1). If the subject has received radiation therapy, at least
- •one measurable lesion must be outside the area of radiation, or at least one
- •measurable lesion must be progressing inside the area of radiation.;4. Be able to swallow, retain, and absorb oral medications and oral nutrition.;5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.;6. Demonstrate adequate organ function as defined by the following table, all screening
- •labs should be performed within one-two weeks of treatment initiation. Be able to adhere to dose and visit schedules.;8. Each female subject of childbearing potential must have a negative urine or serum
- •pregnancy test. If the urine test is positive or cannot be confirmed as negative, a
- •serum pregnancy test will be required. The serum pregnancy test must be negative
- •for the subject to be eligible.;9. Each female subject who is not free from menses for >2 years, post hysterectomy /
- •oophorectomy, or surgically sterilized, must be willing to use either 2 adequate
- •barrier methods or a barrier method plus a hormonal method of contraception to
- •prevent pregnancy or to abstain from heterosexual activity throughout the study,
- •starting with Visit 1 through 90 days after the last dose of study therapy. Approved
- •contraceptive methods include, for example: intra uterine device, diaphragm with
- •spermicide, cervical cap with spermicide, male condoms, or female condom with
- •spermicide. Spermicides alone are not an acceptable method of contraception.
- •Each male subject must agree to use an adequate method of contraception or abstain
- •from heterosexual intercourse with a partner who could become pregnant starting
- •with the first dose of study drug through 90 days after the last dose of study therapy.
排除标准
- •Has unstable or progressing central nervous system (CNS) metastasis. Subjects with known CNS metastasis may be included if the subject is asymptomatic for 1 month with no requirement for steroids or antiseizure medications.
- •Has active gastrointestinal disease or a disorder or a history of surgery that significantly alters gastrointestinal motility or absorption in the opinion of the investigator.
- •Has received ERK inhibitors for the disease under study.
- •For Arm A: The subject has a known dihydropyrimindine dehydrogenase (DPD) deficiency or known UGT1A1*28 polymorphism.
- •For Arm C:
- •- The subject has received prior therapy with an anti-PD-1 or anti PD-L1 antibody.
- •- The subject has an active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy
- •- The subject is on chronic systemic steroid therapy or on any other form of immunosuppressive medication.
- •Has a known hypersensitivity to MK-8353, irinotecan (Arm A), leucovorin (Arm A), 5-FU (Arm A), MK-8669 (Arm B), MK-3475 or any other mAb (Arm C) or their components.
- •Has received any treatment more recently than the indicated washout period prior to the start of treatment with MK-8353 combinations, or must continue to receive any treatment listed in the exclusion medication list during the current trial.
- •Has clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic diseases that would make implementation of the protocol difficult.
研究者
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