NCT06708663

HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours

Phase IIa Study of HX009+IN10018 in Patients With Advanced Solid Tumours, Including Biliary Tract Malignancies and Malignant Melanoma, Treated With or Without Standard Chemotherapy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Hangzhou Hanx Biopharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase IIa study of HX009+ IN10018 in combination with or without standard chemotherapy in patients with advanced solid tumours including biliary tract malignancies and malignant melanoma

Detailed description

The Part1 safety run-in stage: About 6\~24 patients are expected to be enrolled in the safety run-in stage, 3\~6 cases will be enrolled first in the 7.5mg/kg dose group, and if the 7.5mg/kg dose level is tolerable, then 3\~6 cases will continue to be enrolled up to the 10mg/kg dose group; if the 7.5mg/kg dose group can not be tolerated, it will be decided whether to add a new lower dose level after discussion between the sponsor and the investigators, based on the '3+3' rule, which determines the actual number of cases enrolled, the number of replacement subjects, and the number of dose groups to be explored for each cohort based on observed safety data. Part I Phase IIa stage: Based on data from safety run-in stage , a target ORR of 20% for HX009 in combination with IN10018 in patients with treated advanced biliary cancers was pre-set, and a total of 20-30 subjects were planned to be enrolled at the appropriate recommended dose level, and HX009 in combination with IN10018 for the treatment of patients with advanced biliary malignancies was considered to be a treatment option for HX009 in combination with IN10018 if the best efficacy was observed as a CR or a PR in at least 5 subjects. patients with advanced biliary malignancies, supporting further exploratory studies.

Conditions

• Biliary Tract Cancer
• Melanoma

Interventions

Type	Name	Description
DRUG	HX009+IN10018	The 7.5 mg/kg dose group will first enroll 3 to 6 subjects, and if the 7.5 mg/kg dose group is tolerable, then 3 to 6 subjects will continue to be enrolled into the 10 mg/kg dose group; if the 7.5 mg/kg dose group is not tolerable, a decision will be made to add a new, lower dose group after discussion between the sponsor and the investigator; in addition, based on the available study data, the sponsor and the investigator will discuss and decide whether to add an unplanned dose group or an exploratory group and decide on the appropriate recommended dose (RP2D) for the Phase IIa study. IN10018 is fixed dose at 100mg daily.

Timeline

• Start date: 2025-01-17
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2024-11-27
• Last updated: 2026-04-16

Locations

1 site across 1 country: China