Trials / Unknown
UnknownNCT06322095
A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors
An Open Exploratory Study to Evaluate The Preliminary Efficacy of GH21 Combined With Primary Targeting or Immunotherapy in Patients With Advanced Solid Tumors Which Targeted or Immunotherapy Has Progressed
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Suzhou Genhouse Bio Co., Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is aim to evaluate the preliminary efficacy of GH21 combined with previous target therapy or immunotherapy in patients with advanced solid tumors.
Detailed description
This study preset two dose groups, dose group 1 is GH21 15 mg (BIW, D1D2) combined with ALK inhibitor, or MET inhibitor, or BRAF inhibitor +MEK inhibitor, or PD-1 inhibitor, or EGFR monoantibody, or other drugs such as FGFR inhibitor, and it is planned to enroll up to 36 subjects. Dose group 2 was GH21 6 mg (QD) combined with ALK inhibitor, or MET inhibitor, or BRAF inhibitor +MEK inhibitor, or PD-1 inhibitor, or EGFR monoclonal antibody, or other drugs such as FGFR inhibitor, and was planned to enroll up to 36 subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PD-1 | Previous PD-1 |
| DRUG | MET inhibitor | Previous MET inhibitor |
| DRUG | ALK inhibitor | Previous ALK inhibitor |
| DRUG | BRAF Inhibito | Previous BRAF inhibitor |
| DRUG | EGFR Monoclonal antibody | Previous EGFR Monoclonal antibody |
| DRUG | GH21 | Oral, 15mg BIW or 6mg QD |
| DRUG | MEK Inhibitor | Previous MEK Inhibitor |
Timeline
- Start date
- 2024-03-22
- Primary completion
- 2025-09-30
- Completion
- 2025-12-31
- First posted
- 2024-03-20
- Last updated
- 2024-10-01
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06322095. Inclusion in this directory is not an endorsement.