PACTR202203779032822尚未招募1 期
A PHASE Ia/Ib DOSE-ESCALATION AND DOSE- EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-6036 AS A SINGLE AGENT AND IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS WITH A KRAS G12C MUTATIO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •? Signed Informed Consent Form
- •? Age =18 years at time of signing Informed Consent Form
- •? Ability to comply with the study protocol, in the investigator’s judgment
- •? Evaluable or measurable disease per RECIST v1.1
- •? Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •? Life expectancy of =12 weeks
- •? Adequate hematologic and organ function within 14 days prior to initiation of study
- •treatment, defined by the following:
- •? Absolute neutrophil count =1200/µL
- •? Hemoglobin =9 g/dL
- •? Platelet count =100,000/µL
- •? Total bilirubin =1.5 x ULN
- •? Serum albumin =2.5 g/dL
- •? AST and ALT=2.5 x ULN with the following exception:
- •Patients with documented liver metastases may have AST and/or
- •ALT =5.0 x ULN.
- •? For women of childbearing potential: Agreement to remain abstinent (refrain from
- •heterosexual intercourse) or use contraception, and agreement to refrain from
- •donating eggs, as defined below:
- •Women must remain abstinent or use contraceptive methods with a failure rate
- •of < 1% per year and must refrain from donating eggs during the treatment
- •period and after the final dose of study treatment for at least:
- •? 6 months for GDC-6036
- •? 5 months for atezolizumab (Arm B)
- •? 2 months for cetuximab (Arm C)
- •? 6 months for bevacizumab (Arm D)
- •? 2 weeks for erlotinib (Arm E)
- •? 6 months for GDC-1971 (Arm F)
排除标准
- •? Inability or unwillingness to swallow pills
- •? Inability to comply with study and follow-up procedures
- •? Malabsorption syndrome or other condition that would interfere with enteral
- •? Known and untreated, or active central nervous system (CNS) metastases
- •(progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- •Patients with a history of treated CNS metastases are eligible, provided they
- •meet all of the following criteria:
- •- Measurable or evaluable disease outside the CNS
- •- No history of intracranial hemorrhage or spinal cord hemorrhage
- •- No ongoing requirement for corticosteroids as therapy for CNS
- •metastases, with corticosteroids discontinued for ? 2 weeks prior to
- •enrollment and no ongoing symptoms attributed to CNS metastases
- •- No stereotactic radiation within 7 days or whole-brain radiation within
- •14 days prior to Day 1 of Cycle 1
- •- No evidence of interim progression between the completion of
- •CNS-directed therapy and the screening radiographic study
- •- Note: Patients with new asymptomatic CNS metastases detected at
- •screening are eligible for the study after receiving radiotherapy and/or
- •surgery. Following treatment, these patients may be eligible without the
- •need to repeat the additional brain scan, if all other criteria are met.
- •? Leptomeningeal disease or carcinomatous meningitis
- •? Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
- •drainage procedures biweekly or more frequently
- •Indwelling pleural or abdominal catheters may be allowed, provided the patient
- •has adequately recovered from the procedure, is hemodynamically stable and
- •symptomatically improved, and after discussion with the Medical Monitor.
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