NL-OMON56137已完成2 期
A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT)M erkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients Who Are Anti-PD-1 or Anti-PD-L1 Treatment Naïve - KRT-232-103 study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
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. For Cohorts 1, 3 and 4 subjects must have failed treatment with at least one
- •PD-1 inhibitor or PD-L1 inhibitor for metastatic MCC. Failure is defined as any
- •subject whose disease has progressed (by RECIST criteria) or those who are
- •intolerant to PD-1 inhibitor or PD-L1 inhibitor treatment. Any PD-1 inhibitor
- •or PD-L1 inhibitor may have been used at any time in the past, with no limit or
- •minimum duration required.
- •2. For Cohort 2, subjects must not have received any anti-PD-1 or
- •anti-PD-L1therapy.
- •3. For Cohort 3, subjects must not have received any prior chemotherapy.
- •4. For Cohort 4, subjects must have received at least 1 line of prior
- •chemotherapy
- •5. Adults >=18 years of age and willing to provide written informed consent.
- •6. ECOG performance status of 0 to 1
- •7. Histologically confirmed MCC. Disease must be measurable, with at least 1
- •measurable lesion by RECIST criteria, version 1.1 (Eisenhauer 2009, Appendix 4).
- •8. For Cohorts 1 and 2: MCC expressing p53WT based on any CLIA or FDA approved
- •sequencing test or by a test approved by the local health authority or, if not
- •available, by a validated test.. For Cohort 2, subjects may be enrolled and
- •treated with avelumab monotherapy before p53WT status is known
- •9. For Cohorts 3 and 4: MCC expressing p53WT based on Central Laboratory testing
- •10. Fresh or archival tumor tissue must be submitted for biomarker assessment.
- •11. Adequate hematological, hepatic, and renal function within 14 days prior to
- •the first dose of KRT-232 as defined in more detail in the protocol
- •12. Agree to comply with contraception requirements as defined in more detail
- •in the protocol
排除标准
- •1. For Cohort 2, subjects must not have autoimmune disease, medical conditions
- •requiring systemic immunosuppression, prior stem cell transplant, or active
- •infection with HBV or HCV.
- •2. Concurrent anticancer treatment such as chemotherapy, cytoreductive therapy,
- •immune therapy, or cytokine therapy within 28 days or approximately 5
- •half-lives, whichever is shorter, prior to the first dose of KRT-232
- •3. Radiation therapy within 2 weeks prior to the first dose of KRT-232
- •4. Toxicity from prior radiation therapy that has not resolved to National
- •Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
- •Grade 0 or Grade 1 (with the exception of Grade 2 alopecia)
- •5. Participation in another interventional clinical trial within the past 4
- •weeks of the first dose of KRT-232 (participation in observational studies is
- •6. Patients previously treated with MDM2 antagonist therapies or p53-directed
- •7. Women who are pregnant or breastfeeding
- •8. History of major organ transplant
- •9. Subjects with known central nervous system (CNS) metastases that are
- •previously untreated
- •10. Uncontrolled intercurrent illness including, but not limited to, acute
- •hepatitis A; known history of human immunodeficiency virus (HIV)-positive;
- •clinically significant cardiac disease (New York Heart Association Class III or
- •IV); symptomatic congestive heart failure; unstable angina pectoris;
- •ventricular arrhythmia; or psychiatric illness/social situations that would
- •limit compliance with study requirements
- •11. Subjects with clinically significant bacterial, fungal, parasitic, or viral
- •infection that requires therapy. Subjects with acute bacterial infections
- •requiring antibiotic use should delay
- •screening/enrollment until the course of antibiotic therapy has been completed.
- •12. Other malignancy within the last 3 years, other than chronic lymphocytic
- •leukemia (CLL), curatively treated basal cell or squamous cell skin cancer,
- •carcinoma in situ of the cervix, organconfined or treated nonmetastatic
- •prostate cancer with normal prostate-specific antigen, in situ breast carcinoma
- •after complete surgical resection, or superficial transitional cell bladder
- •carcinoma. Patients with CLL must not in the opinion of the investigator
- •require or be receiving any treatment for their CLL in order to be eligible.
- •13. Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE
- •criteria, version 5.0).
- •14. Known hypersensitivity or contraindications to any of the study drugs,
- •required prophylaxes or their excipients
研究者
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