Study on SB-4826 for Adults with Advanced Solid Tumors or Non-Hodgkin Lymphomas

Sponsor: University of California, San Diego

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07222631

Provider View

This clinical trial is testing a new drug, SB-4826, to find the safest dose for treating adults with advanced solid tumors or non-Hodgkin lymphomas. The study will see how well the drug works alone or with another medication, rituximab, in these patients.

Patient Parameters

Program Overview

The purpose of this study is to determine the safest dose of the drug SB-4826 for adults with advanced solid tumors or non-Hodgkin lymphomas. The study will explore how the drug works in the body, how it is absorbed, and how it is broken down and removed. Participants will take SB-4826 every other day for up to a year, keep a diary of their doses, and visit the clinic for checkups and tests.

Description

This study is the first to test SB-4826, a new type of cancer treatment, in humans. It aims to find the best dose that can be safely given to patients with advanced solid tumors or non-Hodgkin lymphomas. The study is divided into two phases:

Phase 1:

  • Participants with solid tumors will receive SB-4826 alone, while those with non-Hodgkin lymphomas may receive it alone or with rituximab.
  • The study will start with low doses of SB-4826 and gradually increase to find the highest safe dose.
  • Participants will take SB-4826 twice a week, with doses ranging from 20 to 600 mg.
  • The study will monitor for any side effects and determine the best dose for further testing.

Phase 2:

  • This phase will focus on participants with non-Hodgkin lymphomas.
  • They will receive SB-4826 at the best dose found in Phase 1, along with rituximab.
  • Rituximab will be given weekly for the first cycle, then every 9 weeks for up to a year.

Participants will continue treatment for up to a year or until their cancer progresses or they experience unacceptable side effects.

Eligibility Criteria

Inclusion Criteria

  • Aged 18 and older.
  • Able to give informed consent.
  • Have advanced solid tumors or non-Hodgkin lymphomas that need treatment.
  • Cancer has returned, progressed, or is not suitable for standard treatments.
  • Have at least one measurable tumor.
  • Good blood and organ function.
  • Life expectancy of at least 3 months.
  • Women must not be pregnant or breastfeeding and must use effective birth control.
  • Men must agree to use birth control or remain abstinent during the study.

Exclusion Criteria

  • Cannot take oral medications.
  • Recent cancer treatments or major surgery.
  • History of organ transplant.
  • Significant heart disease or other serious health conditions.
  • Active infections or liver disease.
  • Recent use of certain medications or vaccines.
  • History of severe immune reactions to previous treatments.
  • Active brain metastases, unless previously treated and stable.

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