NCT06484816

TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies

A Dose Escalation and Expansion Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-1942 in Patients with Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shenzhen TargetRx Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TGRX-1942 in patients with advanced solid tumor and/or relapsed or refractory hematological malignancies

Detailed description

This study is designed as a three-part study, with dose escalation, dose expansion and indication expansion phases. Patients with advanced solid tumors will be initially enrolled to the study. Other indications including solid tumors with specific gene mutations, or other hematological malignancies with be considered for expansion phases, with appropriate doses as evaluated at the end of dose escalation phase.

Conditions

• Non Small Cell Lung Cancer
• Advanced Solid Tumor
• Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	TGRX-1942	At dose escalation phase, TGRX-1942 will be given orally to patient once a day under a 7-dose sequence of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, and 60mg. The dose level a particular patient will be assigned depends on the progression of the study and PI evaluation on the safety of previous dose group(s).

Timeline

• Start date: 2024-07-08
• Primary completion: 2027-02-01
• Completion: 2027-06-01
• First posted: 2024-07-03
• Last updated: 2025-02-24

Locations

1 site across 1 country: China