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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07189195
Phase
PHASE1
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TR-002 — DRUG
    Weekly intravenous infusion

Study Details

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.

Key Dates

Start date
Nov 7, 2025
Status verified
Mar 2026
Primary completion
Nov 7, 2029
Completion
Feb 7, 2030

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Incidence of dose limiting toxicity (DLTs) [ Time Frame: From first dose of TR-002 to day 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
OCR Referral Team
[email protected]
916-382-6970
Edward J. Kim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

Related Studies