Radiotherapy with TTI-101 for Pancreatic Cancer
This study is looking at a new way to treat pancreatic cancer that is borderline resectable (meaning it's on the edge of being able to be removed by surgery) or locally advanced (meaning it has grown into nearby tissues but hasn't spread far). Researchers are combining stereotactic body radiation therapy (SBRT), a focused type of radiation, with a drug called TTI-101. The goal is to see what dose of TTI-101 and SBRT is safe and can be recommended for future studies. You might be able to join if you are 18 or older, have this type of pancreatic cancer, and have already completed standard chemotherapy if your cancer is borderline resectable. This study plans to enroll 18 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 18 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for an estimated 2 years and 3 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06141031
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~24 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:TTI-101Stereotactic body radiation therapy
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of TTI-101 and SBRT
Measured over Through completion of follow-up (estimated to be 2 years and 3 months)
Conditions
Where it's being run
2 sites across 2 statesColorado1
Missouri1
Study leadership
- Sana Karam, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Pathologically confirmed pancreatic adenocarcinoma that is borderline resectable or locally advanced as defined by NCCN guidelines, with no expected arterial resection/reconstruction.
Patients who are borderline resectable must have completed standard of care induction chemotherapy between 1 and 3 weeks prior to planned start of TTI-101 + SBRT. Patients who exceed this window may be considered for enrollment if they complete an additional cycle of induction chemotherapy prior to initiation of study treatment (per provider discretion). The amount of induction chemotherapy cycles allowed will be left to the discretion of the treating medical oncologist. There is no timing restriction for patients with locally advanced disease.
At least 18 years of age.
ECOG performance status ≤ 2
Adequate bone marrow and organ function as defined below:
Absolute neutrophil count ≥ 1.0 K/cumm
Platelets ≥ 70 K/cumm
Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this criterion)
Total bilirubin ≤ 2 mg/dL
AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
Serum albumin ≥ 2.8 g/dL
Ionized calcium ≤ 1.5 mmol/L, calcium ≤ 12 mg/dL, or corrected serum calcium ≤ IULN)
Measured creatinine clearance \> 40 mL/min or calculated creatinine clearance \> 40 mL/min by Cockcroft-Gault or by 24-hour urine collection for determination of creatinine clearance (calculations in protocol).
Able to swallow pills.
INR and aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy (in which case INR and PTT must be within therapeutic range of intended use of anticoagulants)
The effects of TTI-101 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use at least 1 highly effective method of contraception from screening through the duration of study participation, and for 30 days after last dose of TTI-101. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform the treating physician immediately.
Agreement to adhere to Lifestyle Considerations throughout study duration.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion
Prior treatment for pancreatic cancer in the past 2 years (outside of the induction chemotherapy received for the current diagnosis).
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device overlapping with study treatments within 3 months preceding study entry at the discretion of the PI.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to TTI-101 or other agents used in the study.
Uncontrolled intercurrent illness including but not limited to: ongoing or active infection (fungal, bacterial, or viral (including COVID-19)), sepsis, acute and chronic active infectious disorders (including viral and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy), and chronic pancreatitis. Patients with a recent COVID-19 diagnosis must have fully recovered from all COVID-19 symptoms for 2 weeks prior to the start of study treatment.
Significantly impaired cardiac function such as symptomatic congestive heart failure with NYHA Class III or IV, unstable angina pectoris, myocardial infarction within the last 12 months prior to study entry, serious cardiac arrhythmia (including QTc prolongation of \> 470 ms and/or pacemaker), or prior diagnosis of congenital long QT syndrome.
Ongoing toxicity due to induction chemotherapy, unless returned to baseline or grade 1 or less (except alopecia and labs noted in inclusion criterion #5).
Has had major surgery within 3 weeks prior to starting TTI-101 or has not recovered from major side effects due to surgery.
Presence of pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequent). Participants with indwelling catheters for control of effusions or ascites are allowed.
History of cerebrovascular accident or stroke within the previous 2 years.
History of hepatic encephalopathy.
Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
History of malabsorption or other chronic gastrointestinal disease or condition that may hamper compliance or absorption of TTI-101.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 5 days of study entry.
HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
What this trial measures
- Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of TTI-101 and SBRTThrough completion of follow-up (estimated to be 2 years and 3 months)
* The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the dose-limiting toxicity (DLT) evaluation period. * The final determination of the RP2D will be based on an overall evaluation of the totality of the available data observed in phase IB.