drugset
drugset / Trial / NCT07347171

A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies

NCT07347171 ↗

Phase 1 Recruiting 45 enrolled Cullgen (Shanghai),Inc
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn about the safety of drug CG009301. It also learns if drug CG009301 works to treat in Participants with relapsed or refractory adult haematological malignancies. The main question\[s\] it aims to answer are: 1. To determine the maximum tolerated dose (MTD) and/or objective best dose (OBD) of CG009301 for injection in subjects with relapsed or refractory adult haematological malignancies. 2. To establish subsequent dosing regimens for CG009301 for injection. 3. To characterise the safety profile and tolerability of CG009301 for injection. Participants will Receive treatment with CG009301 until disease progression.

Timeline

Start
2025-04-17
Primary completion
2027-12-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject CG009301 Unknown 0.25 mg Intravenous
Subject CG009301 Unknown 0.5 mg Intravenous
Subject CG009301 Unknown 1 mg Intravenous
Subject CG009301 Unknown 1.6 mg Intravenous
Subject CG009301 Unknown 2.5 mg Intravenous
Subject CG009301 Unknown 3.5 mg Intravenous
Subject CG009301 Unknown 5 mg Intravenous
Subject CG009301 Unknown 6.5 mg Intravenous
Subject CG009301 Unknown 8.25 mg Intravenous
Subject CG009301 Unknown 10 mg Intravenous

Indications

acute myeloid leukemia myelodysplastic syndrome