Trials / Not Yet Recruiting
Not Yet RecruitingNCT07480681
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (KAT6A/B Small Molecule Inhibitor) in Patients With Advanced/Metastatic Solid Tumor
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- Sponsor
- Shanghai Henlius Biotech · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary efficacy of HLX97 ( KAT6A/B inhibitor) in patients with advanced/metastatic solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HLX97 | HLX 97 will be taken as an oral medication. |
| DRUG | Fulvestrant | Fulvestrant will be taken as an intramuscular medication. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2028-03-01
- Completion
- 2028-06-01
- First posted
- 2026-03-18
- Last updated
- 2026-03-18
Source: ClinicalTrials.gov record NCT07480681. Inclusion in this directory is not an endorsement.