Trials / Active Not Recruiting
Active Not RecruitingNCT05024045
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
A Phase 1 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients With Advanced Hematologic Malignancies
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 316 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find out whether the study drug, LOXO-338, is safe and effective in patients with advanced blood cancer. Patients must have already received standard therapy. The study may last up to approximately 3 years.
Detailed description
This study will be conducted in 2 parts. Part 1 will evaluate LOXO-338 as monotherapy. If safety and initial evidence of efficacy of LOXO-338 monotherapy are confirmed, part 2 will evaluate the combination of LOXO-338 with the highly selective, noncovalent Bruton's tyrosine kinase (BTK) inhibitor, pirtobrutinib (LOXO-305).
Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoma, B-cell Marginal Zone
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- B-cell Lymphoma
- Waldenstrom Macroglobulinemia
- Lymphoma, Mantle-Cell
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LOXO-338 | Oral |
| DRUG | Pirtobrutinib | Oral |
Timeline
- Start date
- 2021-09-30
- Primary completion
- 2023-06-14
- Completion
- 2026-06-01
- First posted
- 2021-08-27
- Last updated
- 2026-03-03
Locations
23 sites across 4 countries: United States, France, Italy, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05024045. Inclusion in this directory is not an endorsement.