CTIS2023-505627-30-00招募中1 期
An Open-label, Dose Escalation, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors - TAK-676-1002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 368
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 65+（—）
- 性别
- All
入选标准
- •Adult male or female patients aged 18 years or older. For Japan safety lead-in: Japanese who are living in Japan., Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per NCI CTCAE Version 5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and/or autoimmune endocrinopathies with stable endocrine replacement therapy., In dose escalation Part 1 (not applicable for the Japan safety lead-in), once peripheral evidence of TAK-676 pharmacodynamic stimulation of the innate and/or adaptive immune system is observed in the blood and/or an imaging response (complete response [CR]/partial response [PR]) is observed in at least 1 patient, subsequent patients must: • Have at least 1 lesion amenable for biopsy. • Agree to have 2 tumor biopsies: 1 during the screening period and 1 while on TAK-676 treatment (See Section 9.4.16.2 for timing). In dose expansion Parts 2 and 3 (with the exception of the safety lead-in in Part 2B), patients must be willing to consent to mandatory pretreatment and on-treatment tumor biopsy, if deemed safely accessible. In Parts 1, 2 and 3 once the target number of paired biopsies have been collected and analyzed to evaluate intra-tumor pharmacodynamics, according to Appendix L, additional paired pretreatment and on treatment biopsies will be optional, but not required., Patients must have at least 1 RECIST v.1.1–evaluable measurable lesion. For the dose escalation phase (Part 1) only, nonmeasurable only disease is acceptable., PK/pharmacodynamic blood must be drawn on a peripherally-inserted catheter. TAK-676 is preferentially administered through a central line, but peripheral infusion is acceptable. If a peripheral line is used for TAK-676 and/or pembrolizumab infusion, it must be separate than the one1 used for PK/pharmacodynamic collection., Female patients must be: • Postmenopausal (natural amenorrhea and not due to other medical reasons) for at least 1 year before the screening visit, OR • Surgically sterile, OR • If they are of childbearing potential, agree to practice 2 effective methods of contraception (see Section 8.9) at the same time, from the time of signing the informed consent through 180 days after the last dose of study drug(s), OR • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. – Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception., Male patients, even if surgically sterilized (ie, status postvasectomy), must: • Agree to practice effective barrier contraception (see Section 8.9) during the entire study treatment period and through 180 days after the last dose of study drug, OR • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. – Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception., Written consent must be obtained., Capacity to give informed consent. Proxy consenting will only be allowed where permitted by local regulations or laws., Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1., Patients to have a life expectancy of >12 weeks., TAK-676 SA (dose escalation Part 1A): • Patients with histologically confirmed (cytological diagnosis
排除标准
- •History of any of the following =6 months before first dose of study drug(s): congestive heart failure New York Heart Association Grade III or IV , unstable angina, myocardial infarction, persistent hypertension =160/100 mm Hg despite optimal medical therapy, ongoing cardiac arrhythmias of Grade >2 (including atrial flutter/fibrillation or intermittent ventricular tachycardia), other ongoing serious cardiac conditions (eg, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy), or symptomatic cerebrovascular events. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular weight heparin, is allowed., Chronic, active hepatitis (eg, patients with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus [HCV]-RNA). •Note: Patients who have positive hepatitis B core antibody can be enrolled but must have an undetectable serum hepatitis B virus-DNA. Patients who have positive hepatitis C virus antibody must have an undetectable HCV-RNA serum level., For patients in the dose escalation SA Part 1A only: refusal of standard therapeutic options., For patients receiving pembrolizumab only: contraindication and/or intolerance to the administration of pembrolizumab. For patients receiving chemotherapy in Part 2B: contraindication and/or intolerance to the administration of both platinum agents (cisplatin and carboplatin) and/or 5-FU., Any illness, metabolic dysfunction, physical examination finding, or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug or that would limit compliance with study requirements or compromise ability to provide written informed consent., Patient has had any other prior or concurrent malignancy within 2 years prior to enrollment with the following exceptions: adequately treated localized basal cell or squamous cell carcinoma, or curatively treated in situ carcinoma of the cervix or breast. Other exceptions may be considered upon sponsor consultation., Treatment with any investigational products and systemic anticancer drugs (including vascular endothelial growth factor inhibitors), within 28 days or 5 half lives, whichever is shorter, before C1D1 of study drug(s)., Concurrent chemotherapy (except for Part 2B), immunotherapy (except for pembrolizumab in Part 1B, Part 2, and Part 3), biologic, or hormonal therapy (except for adjuvant endocrine therapy for a history of breast cancer). Concurrent use of hormones for noncancer-related conditions is acceptable (except for corticosteroid hormones, unless allowed per exclusion criterion 19)., Radiation therapy within 14 days (42 days for radiation to the lungs) and/or systemic treatment with radionuclides within 42 days before C1D1 of study drug(s). Patients with clinically relevant ongoing pulmonary complications from prior radiation therapy are not eligible., Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 7 days of C1D1 of study drug(s), with the following exceptions: • Topical, intranasal, inhaled, ocular, intra-articular, and/or other nonsystemic corticosteroids. • Premedications required for CT or MRI scans • Physiological doses of replacement steroid therapy (eg, for adrenal insufficiency). Refer to Section 8.7 for a list of allowed steroid therapy and doses. • For patients enrolled in Part 2B, chemotherapy premedication with steroids can be administered acco
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