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

NCT04977167 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-10-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • HitGen Inc.

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi · National Cancer Center/Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-28
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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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 NCT04977167 on ClinicalTrials.gov