Clinical trial · Interventional
Safety and Activity of SNX-5422 Plus Ibrutinib in CLL
A Phase 1, Open-label Study of SNX-5422 and Ibrutinib in Chronic Lymphocytic Leukemia Subjects With a Mutation in Bruton's Tyrosine Kinase
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
SNX-5422 is a prodrug of SNX-2112, a potent, highly selective, small molecule inhibitor of the molecular chaperone heat shock protein 90 (HSP90). Hsp90 inhibitors may overcome ibrutinib resistance in Mantle cell lymphomas and this study will investigate whether the addition of SNX-5422 to an established dose of ibrutinib will result in the removal of mutated BTK from blood mononuclear cells and/or prevents or delays disease progression of subjects with CLL
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNX-5422 plus ibrutinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SNX-5422 plus ibrutinib
- description
- Open-label administration of SNX-5422 capsules dosed in the morning once every other day for 21 days (11 doses) followed by a 7 day drug free period and daily with the established ibrutinib dose for 28 days of a 28-days cycle. Subjects will repeat the 28-day schedule until the cancer progresses or the subject is unable to tolerate the therapy
- interventionNames
- Drug: SNX-5422 plus ibrutinib
Primary outcomes (1)
- measure
- Efficacy of the combination of SNX-5422 and ibrutinib
- timeFrame
- Every 12 weeks up to 52 weeks
- description
- Change in percent of mutated BTK in CLL cells
Secondary outcomes (4)
- measure
- Number of subjects reporting adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males or non-pregnant, non-breastfeeding females 18 years-of-age or older * A diagnosis of CLL as defined by IWCLL 2008 criteria and currently on treatment with ibrutinib without evidence of disease progression. * No more than 4 prior lines of anti leukemia therapy (not including ibrutinib) * Presence of mutated BTK in ≥ 4% of peripheral blood or bone marrow CLL cells, or ≥1% and rising on two separate measurements obtained at least 28 days apart. * Life expectancy of at least 9 months * Karnofsky performance score 70 * Adequate baseline laboratory assessments * Signed informed consent form * Recovered from toxicities of previous anticancer therapy to CTCAE Grade ≤ 1 with the exception of alopecia * Subjects with reproductive capability must agree to practice adequate contraception methods. Exclusion Criteria: * Subjects experiencing toxicity with ibrutinib * Prior treatment with any Hsp90 inhibitor. * Major surgery or significant traumatic injury within 4 weeks of starting study treatment. * Conventional chemotherapy or radiation within 4 weeks. * The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422 * Screening ECG QTc interval 470 msec for females, 450 msec for males. * At increased risk for developing prolonged QT interval unless corrected to within normal limits prior to first dose of SNX-5422 * Patients with chronic diarrhea or with Grade 2 or greater diarrhea despite appropriate medical management. * Gastrointestinal diseases or conditions that could affect drug absorption * Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis. * History of documented adrenal dysfunction not due to malignancy. * History of chronic liver disease. * Active hepatitis A or B. * Current alcohol dependence or drug abuse. * Use of an investigational treatment (except for ibrutinib) from 30 days prior to the first dose * Glaucoma, retinitis pigmentosa, macular degeneration, or any retinal changes detected by ophthalmological examination that are considered clinically important by examiner. * Psychological or social reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.
References
Publications (0)
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