EUCTR2021-006712-93-DK进行中（未招募）1 期
A Phase 1/Phase 2 Study to Evaluate the Safety and Tolerability of MK-1088 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.The participant must have a histologically- or cytologically-confirmed diagnosis of advanced/metastatic solid tumor by pathology report and have received, have been intolerant to, or have been ineligible for treatment known to confer clinical benefit
- •For metastatic castrate-resistant prostate cancer only:
- •Must have previously received docetaxel, prior treatment with one other chemotherapy is allowed as well as up to 2 second-generation hormonal manipulations
- •Have prostate cancer progression within 6 months before to screening, as determined by the investigator:
- •a.PSA progression using local laboratory values as defined by a minimum of 2 rising PSA levels with an interval of =1 week between each assessment where the PSA value at screening should be =2 ng/mL
- •b.Radiographic disease progression in soft tissue based on PCWG-modified RECIST 1.1 or RECIST 1.1 criteria with or without PSA progression
- •c.Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression
- •2.Disease per PCWG-modified RECIST 1.1 for mCRPC or measurable disease per 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
- •For participants with metastatic castrate-resistant prostate cancer:
- •a.Have PCWG-modified RECIST 1.1 measurable prostate cancer on CT or MRI scans as assessed by the local site/investigator/radiology
- •b.Detectable bone metastases by whole body bone scintigraphy as per PCWG guidance
- •3.Is male or female, from minimum of 18 years of age inclusive, at the time of providing informed consent
- •4.If male, agrees to the following during the intervention period and for at least 7 days after the last dose of MK-1088:
- •Abstains from heterosexual intercourse as their preferred and usual lifestyle and agrees to remain abstinent
- •Uses contraception unless confirmed to be azoospermic as detailed below:
- •-Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant
- •-Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •5.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 low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle,during the intervention period and for at least 7 days after the last dose of MK-1088 and for at least 120 days after the last dose of pembrolizumab, whichever occurs last after the last dose of study intervention
- •-Has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative, 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 7 days after study intervention with MK-1088 or 120 days from the last dose of pembrolizumab
- •-Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator
- •6.The participant has provid
排除标准
- •1.Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks 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
- •2.Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- •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, 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 had a severe hypersensitivity reaction to treatment with a monoclonal antibody/components of the study intervention
- •5.Has an active infection requiring therapy
- •6.Has a history of interstitial lung disease
- •7.Has a history of pneumonitis that required steroids or current pneumonitis
- •8.Has an active autoimmune disease that has required systemic treatment in the past 2 years
- •9.Has concurrent active Hepatitis B and Hepatitis C virus infection
- •10.HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •11.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
- •12.Has known psychiatric or substance abuse disorders that would interfere with the participant’s ability to cooperate with the requirements of the study
- •13.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through the duration of contraception after the last dose of study intervention
- •14.Has not fully recovered from any effects of major surgery without significant detectable infection. Surgeries that required general anesthesia must be completed at least 2 weeks before first study intervention administration. Surgery requiring regional/epidural anesthesia must be completed at least 72 hours before first study intervention administration and participants should be recovered
- •15.Has a history or current evidence of a GI condition or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications; any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, make administration of the study drugs hazardous, or make it difficult to monitor adverse effects such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •16. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhyt
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