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

ConditionsAdvanced Malignant Solid NeoplasmMetastatic Malignant Solid NeoplasmMetastatic Pancreatic AdenocarcinomaRefractory Pancreatic AdenocarcinomaStage III Pancreatic Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Unresectable Malignant Solid NeoplasmUnresectable Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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).

Trial design

Design model

Single group

Treatments tested in this trial

  • TR-002

    Drug

    Weekly intravenous infusion

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Treatment (TR-002)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicity (DLTs)

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

Time frame
From first dose of TR-002 to day 28
2

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.

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

Secondary outcomes

1

Objective response rate (ORR)

Defined as the proportion of eligible subjects who have a complete response or partial response using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Estimate for ORR will be provided, along with exact 2-sided 95% confidence interval.

Time frame
From the first dose of TR-002 up to 1 year post last dose
2

Progression free survival

Will estimate median survival times together with their 95% confidence intervals with the Kaplan-Meier method, and report number of events.

Time frame
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
3

Overall survival

Will estimate median survival times together with their 95% confidence intervals with the Kaplan-Meier method, and report number of events.

Time frame
From the date of enrollment until death from any cause, up to 1 year post last dose
4

Steady state through concentrations in serum

Steady state through concentrations will be calculated using non-compartmental or compartmental PK methods, and will be compared across dose levels using non-parametric statistical testing techniques.

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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