Trials / Withdrawn
WithdrawnNCT04372641
Testing the Safety of CB-5339 in Patients With Cancer
A Phase I Trial of the P97 Inhibitor CB-5339 in Patients With Advanced Solid Tumors and Lymphomas
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies the side effects and best dose of CB-5339 in treating patients with solid tumors that has spread to other places in the body (advanced) or lymphomas. CB-5339 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVE: I. To establish the safety, tolerability, and recommended phase 2 dose (RP2D) of p97 inhibitor CB-5339 tosylate (CB-5339) administered orally on a schedule of once daily, 4 days on and 3 days off, in patients with advanced solid tumors and lymphomas. SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetic profiles of CB-5339. II. To assess the preliminary antitumor activity of CB-5339 in patients with advanced solid tumors and lymphomas. III. To determine the effects of CB-5339 on the ubiquitin proteasome system and on markers of cell death in pre- and post-treatment tumor biopsies and peripheral blood mononuclear cell (PBMC)s. EXPLORATORY OBJECTIVE: I. To evaluate potential associations between CB-5339 activity and genomic alterations assessed in circulating tumor deoxyribonucleic acid (DNA) (ctDNA). OUTLINE: This is a dose-escalation study. Patients receive p97 inhibitor CB-5339 tosylate orally (PO) once daily (QD) 4 days on and 3 days off. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Conditions
- Aggressive Non-Hodgkin Lymphoma
- Indolent Non-Hodgkin Lymphoma
- Locally Advanced Malignant Solid Neoplasm
- Metastatic Malignant Solid Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | p97 Inhibitor CB-5339 Tosylate | Given PO |
Timeline
- Start date
- 2020-06-18
- Primary completion
- 2021-07-12
- Completion
- 2021-07-12
- First posted
- 2020-05-04
- Last updated
- 2025-09-17
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04372641. Inclusion in this directory is not an endorsement.