NL-OMON53771尚未招募不适用
A Phase 1, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MK-4464 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced / Metastatic Solid Tumors - MK4464-001
Merck Sharp & Dohme (MSD)0 个研究点目标入组 30 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
- 30
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
- •A participant will be eligible for inclusion in the study if the participant
- •meets the following
- •1. Have a histologically or cytologically confirmed advanced/metastatic solid
- •tumor by pathology report and have received, or been intolerant to, all
- •treatment known to confer clinical benefit. Only solid tumors of the following
- •types may be included:
- •Gastric carcinoma
- •Esophageal carcinoma
- •Pancreatic cancer
- •2. Have measurable disease by RECIST 1.1 as assessed by the local site
- •investigator/radiology. Target lesions situated in a previously irradiated area
- •are considered measurable if progression has been shown in such lesions.
- •3. Must submit a baseline tumor sample for analysis (either a recent or
- •archival tumor sample). Details pertaining to tumor tissue submission can be
- •found in the Laboratory Manual.
- •4. Arm A (mTPI part): Have 1 or more discrete malignant lesions that are
- •amenable to biopsy.
- •5. Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •6. Have adequate organ function as defined in the protocol. Specimens must be
- •collected within 7 days before the start of study intervention.
- •7. Is male or female, >=18 years of age at the time of providing informed
- •8. No contraception measures are required for male participants.
- •9. A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and at least one of the following conditions applies:
- •Not a WOCBP
- •A WOCBP and:
- •- Uses a contraceptive method that is highly effective (with a failure rate of
- •<1% per year), or be abstinent from heterosexual intercourse as their preferred
- •and usual lifestyle (abstinent on a long-term and persistent basis) during the
- •intervention period and for at least 120 days after the last dose of study
- •intervention. The investigator should evaluate the potential for contraceptive
- •failure (ie, noncompliance, recently initiated) in relationship to the first
- •dose of study intervention. Contraceptive use by women should be consistent
- •with local regulations regarding the methods of contraception for those
- •participating in clinical studies.
- •- Has a negative highly sensitive pregnancy test ([urine or serum] as required
- •by local regulations) within [specify time frame eg, 72 hours] before the first
- •dose of study intervention. [If a urine test cannot be confirmed as negative
- •(eg, an ambiguous result), a serum pregnancy test is required. In such cases,
- •the participant must be excluded from participation if the serum pregnancy
- •result is positive.]
- •- Abstains from breastfeeding during the study intervention period and for at
- •least 120 days after study intervention.
- •- Medical history, menstrual history, and recent sexual activity has been
- •reviewed by the investigator to decrease the risk for inclusion of a woman with
- •an early undetected pregnancy.
- •10. The participant (or legally acceptable representative) has provided
- •documented informed
- •consent/assent for the study. The participant may also provide consent/assent
- •for FBR. However, the participant may participate in the study without
- 另有 4 项未显示
排除标准
- •The participant must be excluded from the study if the participant meets the
- •following criteria:
- •1. Has had chemotherapy, definitive radiation, or biological cancer therapy
- •within 4 weeks (2 weeks for palliative radiation) before the first dose of
- •study intervention or has not recovered to CTCAE Grade 1 or better from any AEs
- •that were due to cancer therapeutics administered more than 4 weeks earlier
- •(this includes participants with previous immunomodulatory therapy with
- •residual immune-related AEs). Participants receiving ongoing replacement
- •hormone therapy for endocrine immune-related AEs will not be excluded from
- •participation in this study.
- •2. Has a history of a second malignancy, unless potentially curative treatment
- •has been completed with no evidence of malignancy for 2 years. Note:
- •Participants with basal cell carcinoma of the skin, squamous cell carcinoma of
- •the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder,
- •that have undergone potentially curative therapy are not excluded.
- •3. Has clinically active CNS metastases and/or carcinomatous meningitis.
- •Participants with previously treated brain or meningeal metastases may
- •participate and be eligible for treatment provided they are stable and
- •asymptomatic (without evidence of progression by MRI scan of the brain
- •separated by at least 4 weeks after treatment), have no evidence of new or
- •enlarging brain metastases, are evaluated within 4 weeks before first study
- •intervention administration, and are off immunosuppressive doses of systemic
- •steroids at least 2 weeks before enrollment.
- •4. Has an active infection requiring therapy.
- •5. History of an allogenic stem cell transplant or a solid organ transplant.
- •6. Has a history of (noninfectious) pneumonitis/interstitial lung disease that
- •required steroids or has current pneumonitis/interstitial lung disease.
- •7. Has an active autoimmune disease that has required systemic treatment in the
- •past 2 years (ie, with use of disease modifying agents, corticosteroids, or
- •immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.
- •Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid
- •replacement therapy for adrenal or pituitary insufficiency, is not considered a
- •form of systemic treatment and is allowed. Use of nonsystemic steroids is
- •8. HIV-infected participants with a history of Kaposi*s sarcoma and/or
- •Multicentric Castleman*s Disease.
- •9. Has a history or current evidence of any condition, therapy, laboratory
- •abnormality, or other circumstance that might confound the results of the study
- •or interfere with the participant*s participation for the full duration of the
- •study, such that it is not in the best interest of the participant to
- •participate, in the opinion of the treating investigator.
- •10. Has known psychiatric or substance abuse disorders that would interfere
- •with the participant*s ability to cooperate with the requirements of the study.
- •11. Is pregnant or breastfeeding or expecting to conceive or father children
- •within the projected duration of the study, starting with the Screening Visit
- •through 120 days after the last dose of study intervention.
- •12. Has not fully recovered from any effects of major surgery without
- •significant detectable infection. Surgeries that required general anesthesia <br
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