Pancreatic CancerPhase 1NCT06141031
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
A Phase 1 study testing TTI-101 and Stereotactic body radiation therapy in people with Pancreatic Cancer, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- TTI-101 and Stereotactic body radiation therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jan 2024to 30 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 receipt and/or amount of induction chemotherapy cycles allowed will be left to the discretion of the treating medical oncologist. There is no timing restriction or chemotherapy receipt 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
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- 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 and has been deemed an appropriate candidate for investigational TTI-101 treatment based on the opinion of both the treating radiation oncologist and the treating medical oncologist.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Completed
University of Colorado
Aurora, Colorado, 80045
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Sana Karam, M.D., Ph.D., 314-273-3240, sanadkaram@wustl.edu
Sana Karam, M.D., Ph.D.
About this study
Official title: Phase I/IB Trial of Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated any improvement in survival. Preclinical research has established that STAT3 inhibition given concurrently with SBRT and in the maintenance phase acts as a synergistic agent that enhances the pro-inflammatory effects of SBRT while reducing its undesired effects (including fibrosis and immunosuppression). This study exploits the window of opportunity post-chemotherapy to advance the hypothesis that the addition of STAT3 inhibition in combination with SBRT will be safe and will enhance 2-year progression-free survival.
- Conditions
- Pancreatic Cancer
- Being tested
- TTI-101, Stereotactic body radiation therapy
- Keywords
- borderline resectable, locally advanced
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTI-101Drug
Given at the assigned dose assigned in the protocol.
Stereotactic body radiation therapyRadiation
Also called SBRT
Given at the assigned dose and fractions assigned in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| TTI-101 + SBRT Dose Level 0 (original starting dose) | Experimental | * Treatment consists of TTI-101 by mouth twice daily at 400 mg and SBRT (5 fractions of 6.6 Gy each) over the course of 3 weeks.
* After combination therapy is concluded, patients who entered the study as locally advanced will receive up to 10 additional weeks of TTI-101 monotherapy (until a tumor biopsy that will occur between Weeks 9 and 13). After discontinuation of TTI-101, patients will receive SOC chemotherapy as part of their routine care (not dictated by study participation).
* Patients who entered the study as borderline resectable will be assessed following the initial 3 weeks of treatment. If they have reverted to resectable, they will undergo surgery, followed by optional adjuvant chemotherapy at the discretion of their treating team. If they are unresectable, they will follow the path of the locally advanced patients (up to 10 weeks of TTI-101 monotherapy, followed by disease assessment, followed by SOC chemotherapy). Receives: Drug: TTI-101; Radiation: Stereotactic body radiation therapy |
| TTI-101 + SBRT Dose Level -1 (WUSM starting dose) | Experimental | * Treatment of TTI-101 by mouth twice daily at 200 mg \& SBRT (3 fractions of 6 Gy each, approximately every other day but may be given over 2-3 weeks) over the course of 3 weeks.
* After combination therapy, patients who entered the study as locally advanced will receive up to 10 additional weeks of TTI-101 monotherapy (until a tumor biopsy that will occur between Weeks 9-13 if possible). After discontinuation of TTI-101, patients will receive SOC chemotherapy as part of their routine care (not dictated by study participation).
* Patients who entered the study as borderline resectable will be assessed following the initial 3 weeks of treatment. If they have reverted to resectable, they will undergo surgery, followed by optional adjuvant chemotherapy at the discretion of their treating team. If they are unresectable, they will follow the path of the locally advanced patients (up to 10 weeks of TTI-101 monotherapy, followed by disease assessment, followed by SOC chemotherapy). Receives: Drug: TTI-101; Radiation: Stereotactic body radiation therapy |
| TTI-101 + SBRT Dose Level -2 | Experimental | * Treatment consists of TTI-101 by mouth twice daily at 200 mg and SBRT (1 fraction of 12 Gy each) over the course of 3 weeks.
* After combination therapy is concluded, patients who entered the study as locally advanced will receive up to 10 additional weeks of TTI-101 monotherapy (until a tumor biopsy that will occur between Weeks 9 and 13 if possible). After discontinuation of TTI-101, patients will receive SOC chemotherapy as part of their routine care (not dictated by study participation).
* Patients who entered the study as borderline resectable will be assessed following the initial 3 weeks of treatment. If they have reverted to resectable, they will undergo surgery, followed by optional adjuvant chemotherapy at the discretion of their treating team. If they are unresectable, they will follow the path of the locally advanced patients (up to 10 weeks of TTI-101 monotherapy, followed by disease assessment, followed by SOC chemotherapy). Receives: Drug: TTI-101; Radiation: Stereotactic body radiation therapy |
| TTI-101 + SBRT Expansion Phase | Experimental | * Treatment consists of TTI-101 by mouth twice daily at the RP2D dose and SBRT (at the RP2D dose and timing) over the course of 3 weeks.
* After combination therapy is concluded, patients who entered the study as locally advanced will receive up to 10 additional weeks of TTI-101 monotherapy (until a tumor biopsy that will occur between Weeks 9 and 13 if possible). After discontinuation of TTI-101, patients will receive SOC chemotherapy as part of their routine care (not dictated by study participation).
* Patients who entered the study as borderline resectable will be assessed following the initial 3 weeks of treatment. If they have reverted to resectable, they will undergo surgery, followed by optional adjuvant chemotherapy at the discretion of their treating team. If they are unresectable, they will follow the path of the locally advanced patients (up to 10 weeks of TTI-101 monotherapy, followed by disease assessment, followed by SOC chemotherapy). Receives: Drug: TTI-101; Radiation: Stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of TTI-101 and SBRT
- 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.
Measured: Through completion of follow-up (estimated to be 2 years and 3 months)
Secondary outcomes (5)
Progression-free survival (PFS)
PFS is defined as the time from treatment initiation to documented disease progression or death from any cause. The 2-year PFS probability will be reported as a descriptive summary measure.
Measured: 2 years
Overall survival (OS)
OS is defined as the time from treatment initiation to death from any cause. The 2-year OS probability will be reported as a descriptive summary measure.
Measured: 2 years
Pathologic response rate
- Pathologic response rate among patients who receive neoadjuvant TTI-101 in combination with SBRT and subsequently undergo surgical resection (including pCR and/or major pathologic response).
- Pathologic complete response (pCR) is defined as the absence of any vital tumor tissue in the sampled pancreatic resection specimen.
- Major pathologic response is defined as ≤ 10% residual viable tumor cells remaining in the surgical specimen after treatment.
Measured: At the time of surgery (estimated to be 5 weeks)
R0 resection rate among patients who undergo surgical resection
R0 resection is defined as microscopic tumor clearance in the pancreatic resection specimen.
Measured: At the time of surgery (estimated to be 5 weeks)
Frequency of adverse events
Graded according to NCI CTCAE v 5.0.
Measured: From start of treatment through 90 days after last dose of TTI-101 (estimated to be 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start16 Jan 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Tvardi Therapeutics, Incorporated, The V Foundation
- Responsible party
- Sponsor
- Investigators
- Sana Karam, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141031
- Sponsor's protocol ID
- 202602103
- Status last verified
- Sep 2026
- First submitted
- 8 Nov 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IB Trial of Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06141031
- Acronym / sponsor ID
- 202602103
- Conditions
- Pancreatic Cancer
- Keywords
- borderline resectable, locally advanced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Tvardi Therapeutics, Incorporated, The V Foundation
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated any improvement in survival. Preclinical research has established that STAT3 inhibition given concurrently with SBRT and in the maintenance phase acts as a synergistic agent that enhances the pro-inflammatory effects of SBRT while reducing its undesired effects (including fibrosis and immunosuppression). This study exploits the window of opportunity post-chemotherapy to advance the hypothesis that the addition of STAT3 inhibition in combination with SBRT will be safe and will enhance 2-year progression-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TTI-101 + SBRT Dose Level 0 (original starting dose) | Experimental | Drug: TTI-101, Radiation: Stereotactic body radiation therapy* Treatment consists of TTI-101 by mouth twice daily at 400 mg and SBRT (5 fractions of 6.6 Gy each) over the course of 3 weeks. * After combination therapy is concluded, patients who entered the study as locally advanced will receive up to 10 additional weeks of TTI-101 monotherapy (until a tumor biopsy that will occur between Weeks 9 and 13). After discontinuation of TTI-101, patients will receive SOC chemotherapy as part of their routine care (not dictated by study participation). * Patients who entered the study as borderline resectable will be assessed following the initial 3 weeks of treatment. If they have reverted to resectable, they will undergo surgery, followed by optional adjuvant chemotherapy at the discretion of their treating team. If they are unresectable, they will follow the path of the locally advanced patients (up to 10 weeks of TTI-101 monotherapy, followed by disease assessment, followed by SOC chemotherapy). |
| TTI-101 + SBRT Dose Level -1 (WUSM starting dose) | Experimental | Drug: TTI-101, Radiation: Stereotactic body radiation therapy* Treatment of TTI-101 by mouth twice daily at 200 mg \& SBRT (3 fractions of 6 Gy each, approximately every other day but may be given over 2-3 weeks) over the course of 3 weeks. * After combination therapy, patients who entered the study as locally advanced will receive up to 10 additional weeks of TTI-101 monotherapy (until a tumor biopsy that will occur between Weeks 9-13 if possible). After discontinuation of TTI-101, patients will receive SOC chemotherapy as part of their routine care (not dictated by study participation). * Patients who entered the study as borderline resectable will be assessed following the initial 3 weeks of treatment. If they have reverted to resectable, they will undergo surgery, followed by optional adjuvant chemotherapy at the discretion of their treating team. If they are unresectable, they will follow the path of the locally advanced patients (up to 10 weeks of TTI-101 monotherapy, followed by disease assessment, followed by SOC chemotherapy). |
| TTI-101 + SBRT Dose Level -2 | Experimental | Drug: TTI-101, Radiation: Stereotactic body radiation therapy* Treatment consists of TTI-101 by mouth twice daily at 200 mg and SBRT (1 fraction of 12 Gy each) over the course of 3 weeks. * After combination therapy is concluded, patients who entered the study as locally advanced will receive up to 10 additional weeks of TTI-101 monotherapy (until a tumor biopsy that will occur between Weeks 9 and 13 if possible). After discontinuation of TTI-101, patients will receive SOC chemotherapy as part of their routine care (not dictated by study participation). * Patients who entered the study as borderline resectable will be assessed following the initial 3 weeks of treatment. If they have reverted to resectable, they will undergo surgery, followed by optional adjuvant chemotherapy at the discretion of their treating team. If they are unresectable, they will follow the path of the locally advanced patients (up to 10 weeks of TTI-101 monotherapy, followed by disease assessment, followed by SOC chemotherapy). |
| TTI-101 + SBRT Expansion Phase | Experimental | Drug: TTI-101, Radiation: Stereotactic body radiation therapy* Treatment consists of TTI-101 by mouth twice daily at the RP2D dose and SBRT (at the RP2D dose and timing) over the course of 3 weeks. * After combination therapy is concluded, patients who entered the study as locally advanced will receive up to 10 additional weeks of TTI-101 monotherapy (until a tumor biopsy that will occur between Weeks 9 and 13 if possible). After discontinuation of TTI-101, patients will receive SOC chemotherapy as part of their routine care (not dictated by study participation). * Patients who entered the study as borderline resectable will be assessed following the initial 3 weeks of treatment. If they have reverted to resectable, they will undergo surgery, followed by optional adjuvant chemotherapy at the discretion of their treating team. If they are unresectable, they will follow the path of the locally advanced patients (up to 10 weeks of TTI-101 monotherapy, followed by disease assessment, followed by SOC chemotherapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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 receipt and/or amount of induction chemotherapy cycles allowed will be left to the discretion of the treating medical oncologist. There is no timing restriction or chemotherapy receipt 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:
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTI-101Given at the assigned dose assigned in the protocol. | Drug | TTI-101 + SBRT Dose Level -1 (WUSM starting dose), TTI-101 + SBRT Dose Level -2, TTI-101 + SBRT Dose Level 0 (original starting dose), TTI-101 + SBRT Expansion Phase |
| Stereotactic body radiation therapyAlso: SBRTGiven at the assigned dose and fractions assigned in the protocol. | Radiation | TTI-101 + SBRT Dose Level -1 (WUSM starting dose), TTI-101 + SBRT Dose Level -2, TTI-101 + SBRT Dose Level 0 (original starting dose), TTI-101 + SBRT Expansion Phase |
Primary outcome
Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of TTI-101 and SBRT
Time frame: Through 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.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Pathologic response rate
Time frame: At the time of surgery (estimated to be 5 weeks)
R0 resection rate among patients who undergo surgical resection
Time frame: At the time of surgery (estimated to be 5 weeks)
Frequency of adverse events
Time frame: From start of treatment through 90 days after last dose of TTI-101 (estimated to be 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sana Karam, M.D., Ph.D. principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TTI-101 and Stereotactic body radiation therapy in people with Pancreatic Cancer, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sana Karam, M.D., Ph.D. (314-273-3240, sanadkaram@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of TTI-101 and SBRT (time frame: Through completion of follow-up (estimated to be 2 years and 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 2 Nov 2026.