A Phase 1 Study of Bisaminoquinoline Derivative (TR-002) for Injection for Advanced Treatment-Refractory Solid Tumors
University of California, Davis
Summary
This phase I trial tests the safety, side effects and best dose of TR-002 for the treatment of solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable), that has spread from where it first started (primary site) to other places in the body (metastatic) and unresectable or metastatic pancreatic adenocarcinoma that does not respond to treatment (refractory). Chemotherapy drugs, such as TR-002, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. TR-002 may be safe and tolerable in treating patients with advanced, unresectable or metastatic solid tumors and unresectable or metastatic, refractory pancreatic adenocarcinoma.
Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD), which will also be the recommended phase 2 dose (RP2D) of Nadofaragene Firadenovec (TR-002) for the treatment of advanced treatment-refractory solid tumors. II. To evaluate the toxicities of TR-002 administered intravenous weekly. SECONDARY OBJECTIVES: I. To obtain preliminary assessment of anti-tumor activity of TR-002 administered intravenous weekly at the RP2D. II. To evaluate the pharmacokinetics of TR-002 administered intravenous weekly. EXPLORATORY OBJECTIVE: I. To assess the effects of TR-002 on pharmacodynamic…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Aged 18 or over at the time of consent * Pathology or histology-confirmed metastatic or unresectable solid tumor for which standard systemic treatments are no longer effective or not tolerated * For the expansion cohort, participants must have pathology or histology-confirmed metastatic or unresectable pancreatic adenocarcinoma that is refractory and/or intolerant to all standard-of-care systemic treatments (including gemcitabine, nab-paclitaxel, fluoropyrimidine, oxaliplatin, and irinotecan) * Participants in dose escalation may have measurable and/or non-measurable dis…
Interventions
- DrugTR-002
Weekly intravenous infusion
Location
- University of California Davis Comprehensive Cancer CenterSacramento, California