An Open-Label, First-in-Human Phase 1/2, Dose-Escalation and Dose-Expansion/ Combination Therapy Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SB-4826 as a Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphomas and in Combination With Rituximab in Adult Participants With Non-Hodgkin Lymphomas
University of California, San Diego
Summary
The goal of this clinical trial is to learn what dose of the drug SB-4826 can be given safely in patients with solid tumors and non-Hodgkin lymphomas. This drug will be used alone in patients with solid tumors, and will be used alone or in combination with rituximab in patients with non-Hodgkin lymphomas. The main questions this clinical trial aims to answer are: What is the maximum dose of SB-4826 that can be used safely in patients with solid tumors and non-Hodgkin lymphomas, and will it work? How does SB-4826 work in people with cancer? How is SB-4826 absorbed, broken down, and excreted by the body? Participants will: Take drug SB-4826 twice weekly for up to 1 year; keep a diary of when they take SB-4826 at home; visit the clinic for checkups, tests, and fill out study questionnaires.
Description
This is a first-in-human, phase 1/2, dose-escalation and dose-expansion / combination therapy study designed to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of the first-in-class orally bioavailable small ubiquitin-like modifier (SUMO) E1 inhibitor SB-4826, alone and in combination with rituximab (or biosimilar). SUMO E1 inhibitors are a class of anticancer therapies that activate anti-tumor immunity and can directly inhibit the proliferation and survival of cancer cells. SB-4826 is the first SUMO E1 inhibitor that acts through a covalent, allosteric,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1 - Aged 18 and older. 2- Capable of giving signed informed consent. 3- Phase 1 (Dose-Escalation): Histologically or cytologically confirmed locally advanced or metastatic solid tumor or non-Hodgkin lymphomas. For indolent non-Hodgkin lymphomas, there must be an indication for systemic therapy such as: Local symptoms due to progressive or bulky nodal disease; Threat of or present compromise of normal organ function due to progressive or bulky disease; Presence of systemic B symptoms (ie, fevers, weight loss, night sweats); Presence of symptomatic extranodal disease, such…
Interventions
- DrugSB-4826
Small ubiquitin-like modifier E1 inhibitor
- DrugRituximab
Cluster of differentiation 20 blocker
Location
- University of California, San DiegoLa Jolla, California