Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 4:12 AM
Study NCT ID:
NCT07189195
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
A Phase 1 Study of Bisaminoquinoline Derivative (TR-002) for Injection for Advanced Treatment-Refractory Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD), which will also be the recommended phase 2 dose (RP2D) of Nadofaragene Firadenovec (TR-002) for the treatment of advanced treatment-refractory solid tumors.
II. To evaluate the toxicities of TR-002 administered intravenous weekly.
SECONDARY OBJECTIVES:
I. To obtain preliminary assessment of anti-tumor activity of TR-002 administered intravenous weekly at the RP2D.
II. To evaluate the pharmacokinetics of TR-002 administered intravenous weekly.
EXPLORATORY OBJECTIVE:
I. To assess the effects of TR-002 on pharmacodynamic biomarkers relating to the mechanism of action.
OUTLINE: This is a dose-escalation study of TR-002 followed by a dose-expansion study.
Patients receive TR-002 intravenously (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 multigated acquisition (MUGA) scan during screening and undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), tumor biopsy and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days and every 60 days for 1 year.
I. To determine the maximum tolerated dose (MTD), which will also be the recommended phase 2 dose (RP2D) of Nadofaragene Firadenovec (TR-002) for the treatment of advanced treatment-refractory solid tumors.
II. To evaluate the toxicities of TR-002 administered intravenous weekly.
SECONDARY OBJECTIVES:
I. To obtain preliminary assessment of anti-tumor activity of TR-002 administered intravenous weekly at the RP2D.
II. To evaluate the pharmacokinetics of TR-002 administered intravenous weekly.
EXPLORATORY OBJECTIVE:
I. To assess the effects of TR-002 on pharmacodynamic biomarkers relating to the mechanism of action.
OUTLINE: This is a dose-escalation study of TR-002 followed by a dose-expansion study.
Patients receive TR-002 intravenously (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 multigated acquisition (MUGA) scan during screening and undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), tumor biopsy and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days and every 60 days for 1 year.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-06181 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| UCDCC305 | OTHER | University of California Davis Comprehensive Cancer Center | View | |
| P30CA093373 | NIH | None | https://reporter.nih.gov/quic… | View |