NCT07189195 TR-002 for the Treatment of Advanced Unresectable Metastatic Solid Tumors Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma
| NCT ID | NCT07189195 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, Davis |
| Condition | Advanced Malignant Solid Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2029-11-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2025-11-07 with a primary completion date of 2029-11-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 disease. Imaging for disease assessment of measurable and non-measurable disease must be completed within 28 days prior to registration. Participants in dose expansion must have measurable disease per Response Evaluation Criteira in Solid Tumors (RECIST) 1.1 * Adequate cardiac function, assessed by multiple-gated acquisition (MUGA) scan or echocardiography (left ventricular ejection fraction of \> 50%) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Absolute neutrophil count ≥ 1,000/mcL * Platelets ≥ 75,000/mcL * Hemoglobin ≥ 8g/dL * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (\< 3 x ULN in patients with known Gilberts) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN (\< 5 x ULN in patients with known liver metastases) * Creatinine ≤ 1.5 x institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 * For people of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method through 3 months following the last dose of study treatment * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Lactating or pregnant patients or patients of reproductive potential not willing to use effective methods of contraception * Clinically significant toxicities from most recent therapy or intervention prior to study enrollment that have not resolved to baseline or grade 1 (exceptions include alopecia and grade 2 sensory neuropathy) * Participant with a history of the following significant cardiovascular disease will be excluded: * Participant has a history of myocardial infarction or unstable angina within 6 months prior to day 1. * Participant has New York Heart Association (NYHA) Class II or greater congetive heart failure (CHF). * History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to study treatment. * Participant has cardiac arrhythmia, complete left bundle branch block, obligate use of a cardiac pacemaker, long QT syndrome or right bundle branch block with left anterior hemiblock (bifascicular block). * History of congenital long QT syndrome or prolonged corrected QT interval (QTc) \> 470 msec for females and males using Fridericia's formula (unless a pacemaker is in place or additional clinically non-significant condition such as bundle-branch block necessitating use of an alternate formula per cardiologist calculation) or uncorrectable abnormalities in serum electrolytes (i.e., sodium, potassium, calcium, magnesium, phosphorus). An average of triplicate readings for assessing QTc interval may be used * Active bacterial, fungal, and viral infection, as documented by positive culture, radiological imaging techniques, septic fever, or septic shock symptoms * Known hypersensitivity to 4-aminoquinolone compounds * Retinal or visual field changes of any etiology * History of psoriasis * History of porphyria * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency * History of seizure disorder * Any other condition that could compromise the subject's safety or put the study outcomes at undue risk
Contact & Investigator
Edward J Kim, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT07189195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Malignant Solid Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07189195 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07189195 currently recruiting?
Yes, NCT07189195 is actively recruiting participants. Contact the research team at OCRReferral@health.ucdavis.edu for enrollment information.
Where is the NCT07189195 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT07189195 clinical trial?
NCT07189195 is sponsored by University of California, Davis. The principal investigator is Edward J Kim, MD, PhD at University of California, Davis. The trial plans to enroll 52 participants.