Recruiting
Phase 1

TR-002

Sponsor:

UCLA

Code:

NCT07189195

Conditions

Advanced Malignant Solid Neoplasm

Metastatic Malignant Solid Neoplasm

Metastatic Pancreatic Adenocarcinoma

Refractory Pancreatic Adenocarcinoma

Stage III Pancreatic Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TR-002

Study Details

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.

Conditions

Advanced Malignant Solid Neoplasm

Metastatic Malignant Solid Neoplasm

Metastatic Pancreatic Adenocarcinoma

Refractory Pancreatic Adenocarcinoma

Stage III Pancreatic Cancer AJCC v8

Study ID

NCT07189195

Start date

Nov 7, 2025

Status verified date

Jun, 2026

Completion date

Feb 7, 2030

Anticipated

Primary completion date

Nov 7, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (TR-002)

Patients receive TR-002 IV, over 1 hour, on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan during screening and undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study.

Interventions

TR-002

Weekly intravenous infusion

Primary outcome measure

  • Incidence of dose limiting toxicity (DLTs) [ Time Frame: From first dose of TR-002 to day 28 ]
  • Number of participants experiencing treatment-related adverse events [ Time Frame: From first dose of TR-002 to 90 days following the last dose ]

Central Contacts and Locations

Central contacts

Office of Clinical Research

916-382-6970OCRReferral@health.ucdavis.edu

Locations

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Office of Clinical Research

916-382-6970OCRReferral@health.ucdavis.edu

Principal Investigator:

Edward J. Kim, MD, PhD

More Information

Sponsor

University of California, Davis

Last update posted

Jul 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-07-16.