# ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)

Source: https://onco.cc/trials/apex-03/  
OnCo record `apex-03` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2/3 trial testing ICP-248 in chronic lymphocytic leukaemia, now recruiting.

## Summary

ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (APEX-03) is a phase 2/3 interventional study registered as NCT06378138, led by Beijing InnoCare Pharma Tech, and recruiting on the registry. Official title: A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma. Planned enrolment is 226 participants (estimated). The study started in 2024-05-15 and primary completion is expected in 2030-11-25. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Also known as: APEX-03
- Tags: ctgov-ingest
- Registry id: NCT06378138
- Phase: 2/3
- Setting: A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Sponsor: Beijing InnoCare Pharma Tech
- Enrolled: 226

## Sources

- ClinicalTrials.gov NCT06378138: https://clinicaltrials.gov/study/NCT06378138

## Connected records

- cancers: [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/), [Chronic lymphocytic leukaemia, first treatment](https://onco.cc/cancers/cll-treatment-naive/)
- drugs: [ICP-248](https://onco.cc/drugs/icp-248/)
- companies: [InnoCare Pharma](https://onco.cc/companies/innocare/)

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JSON: https://onco.cc/api/v1/entities/apex-03.json