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

NCT07189195 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: UCDCC305NCI-2025-06181P30CA093373
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Metastatic Malignant Solid Neoplasm; Advanced 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

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicity (DLTs)

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

  From first dose of TR-002 to day 28

• Number of participants experiencing treatment-related adverse events

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

  From first dose of TR-002 to 90 days following the last dose

Secondary Outcomes (9)

• Objective response rate (ORR)

  From the first dose of TR-002 up to 1 year post last dose

• Progression free survival

  From the date of enrollment until the first occurrence of disease progression, or death from any cause, whichever occurs earlier, up to 1 year post last dose

• Overall survival

  From the date of enrollment until death from any cause, up to 1 year post last dose

• Steady state through concentrations in serum

  Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion

• Peak Plasma Concentration (Cmax)

  Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion

Study Arms (1)

Treatment (TR-002)

EXPERIMENTAL

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.

Drug: TR-002

Interventions

TR-002 DRUG

Weekly intravenous infusion

Also known as: Bisaminoquinoline Derivative

Treatment (TR-002)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Edward J Kim, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OCR Referral Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 23, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): November 7, 2029
• Study Completion (Estimated): February 7, 2030
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)