NCT05731752

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

Phase I Clinical Trial of Tolerability and Pharmacokinetics of HX009 in Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hangzhou Hanx Biopharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is divided into a screening, treatment, and follow-up period. The Treatment Period may continue to be administered until the investigator determines that the subject no longer benefits, or the subject develops intolerable toxicity, or the subject withdraws informed consent, or the disease progresses or is treated with an antineoplastic agent other than those specified in the protocol, or the subject dies, or is lost to follow-up, or a Phase Ib subject has been administered for 2 years (whichever occurs earliest). Subjects who withdraw from the study/terminate treatment for any reason are required to return for 1 follow-up visit after the last dose, to collect as many RO blood samples as possible after discontinuation (only partial subjects in Phase Ib), and to collect clinical data on safety as well as survival. During the subsequent follow-up period (for Phase Ib only), subjects or family members will receive a telephone visit to inquire about survival and antitumor therapy.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	HX009	The subjects will receive HX009 treatment via IV infusion once every 2 weeks at different dose escalation cohorts

Timeline

• Start date: 2020-05-28
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2023-02-16
• Last updated: 2024-07-22

Locations

1 site across 1 country: China