Actively Recruiting
TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma
Led by University of California, Davis · Updated on 2026-03-05
52
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 or over at the time of consent
- Confirmed metastatic or unresectable solid tumor that no longer responds to or cannot tolerate standard treatments
- For expansion phase: confirmed metastatic or unresectable pancreatic adenocarcinoma refractory or intolerant to all standard treatments
- Measurable or non-measurable disease with imaging within 28 days prior to registration (dose escalation); measurable disease per RECIST 1.1 for expansion
- Adequate heart function with left ventricular ejection fraction greater than 50%
- ECOG performance status of 2 or less
- Absolute neutrophil count of at least 1,000/mcL
- Platelet count of at least 75,000/mcL
- Hemoglobin level of at least 8 g/dL
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal (less than 3 times ULN in Gilbert's syndrome)
- AST and ALT less than or equal to 3 times institutional ULN (less than 5 times ULN if liver metastases present)
- Creatinine less than or equal to 1.5 times institutional ULN or GFR of at least 60 mL/min/1.73 m2
- Use of highly effective contraception at least 1 month before enrollment and agreement to continue through 3 months after last dose (for those of reproductive potential)
- Signed informed consent
- Willingness and availability to comply with all study procedures and duration
You will not qualify if you...
- Pregnant or breastfeeding individuals, or those of reproductive potential unwilling to use contraception
- Significant unresolved toxicities from recent therapy except alopecia and mild sensory neuropathy
- History of myocardial infarction or unstable angina within 6 months prior to day 1
- NYHA Class II or greater congestive heart failure
- History of stroke or transient ischemic attack within 6 months prior to treatment
- Cardiac arrhythmia, complete left bundle branch block, pacemaker use, long QT syndrome, or bifascicular block
- History of congenital long QT syndrome or prolonged QTc interval beyond specified limits
- Uncorrectable electrolyte abnormalities
- Active bacterial, fungal, or viral infection
- Known allergy to 4-aminoquinolone compounds
- Retinal or visual field changes from any cause
- History of psoriasis or porphyria
- Known glucose-6-phosphate dehydrogenase deficiency
- History of seizure disorder
- Any other condition that could compromise safety or study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
O
OCR Referral Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here