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

NCT06708663 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-04-16

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hangzhou Hanx Biopharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Lin Shen · Peking University Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-17
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06708663 on ClinicalTrials.gov