NCT04977167

Clinical Trial of HG146 Administered to Subjects with Advanced Solid Tumors or Lymphoma

A Phase I Open Label Study of HG146 Alone /in Combination with PD-(L)1 Inhibitor Administered with and Without Anticancer Agents in Participants with Advanced Solid Tumors or Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: HitGen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, open-label, repeat-dose, non-randomized, multicenter study to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of HG146 administered orally (PO) alone (Part 1) or co-administered (Part 2) with PD-（L）1 inhibitor in subjects with refractory/relapsed solid tumors or Lymphoma. Part 1 consists of a dose escalation phae,Part2 consists of a dose escalation phase and a cohort expansion phase. In Part 1, escalating doses of HG146 will be evaluated as guided by the "3+3" approach. In Part 2A, escalating doses of HG146 in combination with PD-(L)1 inhibitor will be evaluated as guided by the "3+3" approach. In Part 2B, subjects will receive a single dose level of HG146 as identified based on data from Part 2, in combination with PD-(L)1 inhibitor . A total of approximately 96 subjects will be enrolled in this study, approximately 36 for dose escalation cohorts, and approximately 60 in the expansion cohorts.

Conditions

• Solid Tumor
• Lymphoma

Interventions

Type	Name	Description
DRUG	HG146	HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
DRUG	PD-(L)1 antibody	PD-(L)1 Antibody is available as solution for infusion or lyophilized powder for reconstitution to be administered Q3W. It will be administered as an IV infusion for 30 minutes.

Timeline

• Start date: 2023-07-28
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-07-26
• Last updated: 2024-10-10

Locations

1 site across 1 country: China