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TR-002 for Advanced Unresectable Metastatic Solid Tumors and Pancreatic Cancer

This study is testing a drug called TR-002 for people with advanced solid tumors that cannot be removed by surgery (unresectable) or have spread to other parts of the body (metastatic). It also includes people with pancreatic cancer that has spread or cannot be removed and has not responded to other treatments (refractory). The main goals are to find the safest and most effective dose of TR-002 and to understand its side effects. Researchers will also look for early signs that TR-002 is helping to shrink tumors. You may be able to join if you are 18 or older and have a confirmed advanced solid tumor that is no longer responding to standard treatments. The study is currently unclear about its recruitment status and plans to enroll 52 participants.

Study design
This is an interventional study that will enroll 52 participants. It involves increasing the dose of TR-002 to find the best dose, followed by a dose-expansion phase.
What's involved
You would receive TR-002 through an IV once a week for 28-day cycles. You will also have scans (CT, MRI), tumor biopsies, and blood tests throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After your study treatment ends, you will have follow-up visits at 30 days and then every 60 days for one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07189195

TR-002 for the Treatment of Advanced Unresectable Metastatic Solid Tumors Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of California, Davis
~52 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:TR-002

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicity (DLTs)
Measured over From first dose of TR-002 to day 28
+1 more outcome measured

Conditions

Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Metastatic Pancreatic Adenocarcinoma
Refractory Pancreatic Adenocarcinoma
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Unresectable Malignant Solid Neoplasm
Unresectable Pancreatic Adenocarcinoma

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NCT07189195

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California Davis Comprehensive Cancer Center

    Sacramento, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Edward J Kim, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, Davis

Who to contact

Office of Clinical Research
[email protected]
916-382-6970
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of dose limiting toxicity (DLTs)From first dose of TR-002 to day 28

    The proportion of DLTs at each dose level will be reported with exact binomial 95% confidence intervals.

  • Number of participants experiencing treatment-related adverse eventsFrom first dose of TR-002 to 90 days following the last dose

    Classified by severity, and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.