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Phase 1/2a study to evaluate the safety, activity, and pharmacokinetics of escalating doses of GNS561 in patients with primary or secondary liver cancer

ABSTRACT: Primary objectives: Phase 1:• To characterize the safety and tolerability of GNS561• To identify the recommended Phase 2 dose (RD) • To characterize the PK of GNS561 Phase 2a:• To characterize the safety and tolerability of GNS561 • To identify evidence of antitumor activity (tumor control rate : overall response rate + SD by RECIST 1.1) Primary endpoints: Safety:• Incidence and nature of DLTs by dose level during the 4 week dose escalation phase• Incidence, nature, and severity of adverse events• Change in vital signs, clinical laboratory (chemistry and hematology) values, urinalysis, electrocardiogram (ECGs) Efficacy:• Response rate (CR+ PR) • Disease control rate (CR+PR+SD)• Progression free survival Pharmacokinetics:• GNS561 PK over first 48 hours following first and repeated dose in Cycle 1 and Cycle 2

DISEASE(S): Hepatocellular Carcinomaintrahepatic Cholangiocarcinomapancreatic Adenocarcinoma With Liver Metastasiscolorectal Cancer With Liver Metastasis,Metastatic Colorectal Cancer,Pancreatic Adenocarcinoma Metastatic,Intrahepatic Cholangiocarcinoma,Hepatocellular Carcinoma Non-resectable,Hepatocellular Carcinoma Metastatic

PROVIDER: 2537358 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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