Study on the Tolerability and Pharmacokinetics of HX009 in Patients With Advanced Solid Tumors

Summary

This is an open, multiple-dose administration dose exploratory clinical phase I study to evaluate the safety, tolerability, and PK profile of HX009 Injection in patients with advanced solid tumors and to provide a preliminary measure of its antitumor efficacy. It includes Phase Ia and Phase Ib. phase Ia is a dose exploratory study to evaluate safety, tolerability, and to determine the MTD and/or RP2D.The sponsor and investigator will adjust the magnitude of the dose escalation and the dosing cycle based on the safety and tolerability of HX009 Injection and the PK data that have been obtained, as well as decide whether to add an unplanned dose or dosing cycle to the trial, and recommend the RP2D.The Ia phase dose escalation design model is shown below. The planned dosing cycle for this study is once every 2 weeks (14 days) (Q2W) with IV HX009. Based on the result of phase 1a,10 mg/kg Q2W was the recommended dose for phase 1b. The aimed population for 1b is patients diagnosed with advanced melanoma, and divided into two cohorts:: cohort A ,untreated patients with unresectable or metastatic advanced melanoma;and Cohort B, patients with unresectable or metastatic malignant melanoma that had been treated with immune checkpoint inhibitor therapy. The enrollment of Cohort B will start first.,and whether the cohort A will be initiated depends on the results of the cohort B .The up to 80 patients will be enrolled in Phase Ib.

Timeline

Start

2020-05-28

Primary completion

2024-12-30

Completion

2024-12-30

Drugs

Indications