← Back to Search

Virus Therapy

TTI-101 + Radiotherapy for Pancreatic Cancer

Phase 1 & 2

Recruiting

Led By Sana Karam, PhD, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have pathologically confirmed pancreatic adenocarcinoma with borderline resectable PDAC as defined by NCCN guidelines, with no expected arterial resection-reconstruction, with measurable or evaluable disease be specified for RECIST assessment.

Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL >40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial tests if a drug is safe, effective and tolerable when used with radiation therapy to treat pancreatic cancer.

Who is the study for?

This trial is for adults with borderline resectable pancreatic cancer who've had chemotherapy. They must be able to swallow pills, have certain blood cell counts and organ function levels, not be pregnant or breastfeeding, agree to use contraception, and can't have other serious health issues or recent major surgery.Check my eligibility

What is being tested?

The trial tests TTI-101 combined with Stereotactic Body Radiation Therapy (SBRT) in treating pancreatic ductal adenocarcinoma. It aims to assess the safety and effectiveness of this combination therapy in patients whose condition allows for potential surgical removal of the tumor.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones from similar treatments may include fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies, liver function abnormalities, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a specific type of pancreatic cancer that is almost operable.

Select...

My kidney function, measured by creatinine clearance, is above 40 mL/min.

Select...

I have received initial chemotherapy as per the usual treatment.

Select...

I am 18 years old or older.

Select...

I am using effective birth control and will continue for 30 days after my last treatment dose.

Select...

I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Determine the safety of delivering Stereotactic Body Radiation Therapy in combination with TTI-101 in borderline resectable pancreatic cancer by changes between baseline laboratory assessments

Phase 1: Determine the safety of delivering Stereotactic Body Radiation Therapy in combination with TTI-101 in borderline resectable pancreatic cancer by changes in abdominal distension of each participant.

Phase 1: Determine the safety of delivering Stereotactic Body Radiation Therapy in combination with TTI-101 in borderline resectable pancreatic cancer by changes in ascites of each participant.

+34 more

Secondary outcome measures

Phase 1: Estimate Overall Response Rate by RECIST of the combination of TTI-101 + SBRT

Phase 2: Assess quality of life associated with treatment protocol using EORTC QLQ-C30

Phase 2: Determine the 2-year overall survival (OS) rate of patients treated with hypofractionated radiotherapy plus TTI-101

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase IIExperimental Treatment1 Intervention

An additional 12 patients will be enrolled in phase 2 so that total of 18 patients are treated at RP2D in phase 2 (the 6 patients treated at RP2D in phase 1 will be rolled over to phase 2) of TTI-101 in combination with SBRT on + 3-5 days prior to the first fraction of the SBRT.

Group II: Phase IExperimental Treatment1 Intervention

During Phase 1, up to 2 dose levels of TTI-101 with SBRT will be tested using a 3 + 3 dose-escalation design to determine the RP2D. Up to 3 participants may be enrolled with either 0/3 or 1/3 DLT in order to more fully evaluate the safety and tolerability at a given dose level. Therefore, a minimum of 9 patients (3 at dose 0, and 6 at dose 1) and maximum 18 (6 patients at each dose level) will be enrolled in the phase 1.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tvardi Therapeutics, IncorporatedIndustry Sponsor

4 Previous Clinical Trials

320 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,491 Total Patients Enrolled

Sana Karam, PhD, MDPrincipal InvestigatorUniversity of Colorado, Denver

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment into this trial open at present?

"Based on the data hosted by clinicaltrials.gov, this medical trial is not actively recruiting new participants and has been inactive since November 14th 2023. Although no longer seeking enrollees for this study, there are 735 other trials currently inviting volunteers to join their research efforts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Radiotherapy in Combination With TTI-101 in Patients With Borderline Resectable Pancreatic Cancer

2024. "Trial of Radiotherapy in Combination With TTI-101 in Patients With Borderline Resectable Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06141031.

All > Denver > Colorado Springs