A Phase 1 interventional study of p97 Inhibitor CB-5339 Tosylate in Aggressive Non-Hodgkin Lymphoma, Indolent Non-Hodgkin Lymphoma and Locally Advanced Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI). Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Patients with clinically significant illnesses which would compromise participation in the study, including but not limited to active or uncontrolled infection, immune deficiencies, hepatitis B, hepatitis C, active tuberculosis, uncontrolled asthma, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, myocardial infarction within the past 6 months, cerebral vascular accident/stroke within the past 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients receive p97 inhibitor CB-5339 tosylate PO QD 4 days on and 3 days off. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: p97 Inhibitor CB-5339 Tosylate
Given PO
Also known as: CB 5339 Tosylate, CB-5339 Tosylate, CB5339 Tosylate
Incidence of adverse events (Phase I)
Time frame: 30 days
Recommended phase II dose (Phase I)
Time frame: 30 days
Pharmacodynamic analysis (expansion phase)
Time frame: Up to 2 years
Response assessment
Time frame: Up to 2 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)