EUCTR2020-004129-22-DE进行中（未招募）1 期
A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 475
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
- •Dose Escalation:
- •Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are intolerant or ineligible to approved therapies.
- •Dose Expansion:
- •Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy.Treatment with a prior
- •KRAS G12C inhibitor is not allowed.
- •Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy,and one treatment line of a direct KRAS G12C inhibitor given as a single agent and discontinued within 6 months of the first day of study treatment.
- •Patients with advanced (metastatic or unresectable) KRAS G12C mutant NSCLC who have received a platinum-based chemotherapy regimen and an immune checkpoint inhibitor therapy either in
- •combination or in sequence, unless patient was ineligible to receive such therapy. The patient must have at least one untreated brain metastasis.Treatment with a prior KRAS G12C inhibitor is not allowed.
- •Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received standard-of-care therapy, including a fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy.Treatment
- •with a prior KRAS G12C inhibitor is not allowed.
- •Patients with advanced (metastatic or unresectable) KRAS G12C
- •mutant solid tumors other than NSCLC or CRC who have received standard of care therapy or are intolerant or ineligible to approved
- •therapies. Treatment with a prior KRAS G12C inhibitor is not allowed.
- •All Patients:
- •ECOG performance status of 0 or 1.
- •Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the institution’s own guidelines and requirements for such procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 285
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 190
排除标准
- •Tumors harboring driver mutations that have approved targeted
- •therapies, with the exception of KRAS G12C mutations.
- •Prior treatment with a KRAS G12C inhibitor is excluded for patients in the single agent dose escalation arm and a subset of groups in dose expansion.
- •Prior treatment with a SHP2 or SOS1 inhibitor is not allowed for NSCLC patients enrolled into the dose expansion parts of the JDQ443 single agent and JDQ443 plus TNO155 expansion arms.
- •Untreated brain metastases (applicable to all patients except the brain
- •metastasis group), symptomatic brain metastases (applicable to all
- •patients), or known leptomeningeal disease (applicable to all patients)
- •Clinically significant cardiac disease or risk factors at screening
- •Insufficient bone marrow, hepatic or renal function at screening
研究者
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