A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation -

OVARTIS PHARMA AG0 个研究点目标入组 325 人开始时间: 2021年6月7日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•Dose Escalation:
•Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received and failed standard of care therapy or are intolerant or ineligible to approved therapies.
•Dose Expansion:
•Advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer patients who are in the second or third line treatment setting who have received and failed a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient refused or was ineligible to receive such therapy
•Advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer patients who have received and failed standard-of-care therapy, including a fluropyrimidine-, oxaliplatin-, and / or irinotecan-based chemotherapy, unless patient refused or was ineligible to such therapy.
•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 195
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 130

•Tumors harboring driver mutations that have approved therapies or
•tumors with known activating KRAS, NRAS, HRAS, BRAF, or PTPN11
•(SHP2) mutations, with the exception of KRAS G12C mutations.
•Prior treatment with a KRAS G12C inhibitor will be exclusionary for patients in the single agent dose escalation arm and all patients in dose expansion.
•Prior treatment with a SHP2 inhibitor is not allowed for NSCLC patients enrolled into the dose expansion parts, in the JDQ443 single agent and JDQ443 plus TNO155 expansion groups.
•Active brain metastases, i.e. symptomatic brain metastases or known leptomeningeal disease
•Clinically significant cardiac disease or risk factors at screening
•Insufficient bone marrow, hepatic or renal function at screening

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