Trials / Recruiting
RecruitingNCT06378138
ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)
A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ICP-248 | Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle |
| DRUG | Orelabrutinib | Eligible patients will receive Orelabrutinib orally as per the protocol，once daily for every 28 days as one treatment cycle |
Timeline
- Start date
- 2024-05-15
- Primary completion
- 2030-11-25
- Completion
- 2031-07-25
- First posted
- 2024-04-22
- Last updated
- 2025-11-21
Locations
53 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06378138. Inclusion in this directory is not an endorsement.