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Résztvevőt keres itt: Egyesült Államok1. fázis

Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma

A legfontosabb adatok

Ki végzi
Washington University School of Medicine
Hol
Aurora és St Louis (Egyesült Államok)Mind a 2 helyszín megnézése
Azonosító
Állapot
Toboroz
Fázis
1. fázis
Résztvevők
24 fő, tervezett
Kezdés
2024. jan. 16.
Várható befejezés
2029. jún. 30.
A vizsgálat típusa
Beavatkozással járó, 4 csoport
A vizsgált kezelések
  • TTI-101
  • Stereotactic body radiation therapy
A regiszteradat frissítve
2026. november 6.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akiknek határesetben műthető vagy lokálisan előrehaladott hasnyálmirigyrákja (hasnyálmirigy-adenokarcinóma) van. A sugárkezelést (SBRT) a TTI-101 nevű gyógyszerrel együtt vizsgálja.

Életkor
18 éves vagy idősebb
Nem
Bármely nem részt vehet
A betegség stádiuma
Kóros szövettani vizsgálattal igazolt hasnyálmirigy-adenokarcinóma, amely az NCCN irányelvei szerint határesetben műthető vagy lokálisan előrehaladott, és nem várható artéria eltávolítása vagy rekonstrukciója
Korábbi kezelés
Határesetben műthető betegség: a szokásos indukciós kemoterápiát a TTI-101 + SBRT tervezett kezdete előtt 1–3 héttel be kellett fejezni. Lokálisan előrehaladott betegségnél nincs időkorlát. A hasnyálmirigyrák nem kapott sugárkezelést az elmúlt 2 évben.

A részvétel fő kizáró okai

  • Sugárkezelés a hasnyálmirigyrákra az elmúlt 2 évben
  • Másik daganatos betegség, amely befolyásolhatja a vizsgálat biztonságát vagy eredményét
  • Nem kontrollált betegség, például aktív fertőzés vagy idült hasnyálmirigy-gyulladás
  • Súlyos szívprobléma, például NYHA III. vagy IV. osztályú szívelégtelenség, vagy szívinfarktus az elmúlt 12 hónapban
  • Terhesség vagy szoptatás

A regiszter feltételei, szó szerint

Mind a 27 feltétel megnézéseKevesebb

Ki vehet részt

  • 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; 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

Ki nem vehet részt

  • Prior irradiation of pancreatic cancer in the past 2 years
  • 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
  • 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
  • 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
  • History of cerebrovascular accident or stroke within the previous 2 years
  • 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
  • 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
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to TTI-101 or other agents used in the study
  • 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
  • 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
  • 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
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 5 days of study entry
  • 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

Helyszínek itt: Egyesült Államok

  • University of ColoradoAurora, Egyesült ÁllamokContact: Sana Karam, M.D., Ph.D.No longer taking part
  • Washington University School of MedicineSt Louis, Egyesült ÁllamokContact: Sana Karam, M.D., Ph.D.Résztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 4 csoportja

  • TTI-101 + SBRT Dose Level 0 (original starting dose)A vizsgált kezelés

    * 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).

    Kezelés: TTI-101 és Stereotactic body radiation therapy

  • TTI-101 + SBRT Dose Level -1 (WUSM starting dose)A vizsgált kezelés

    * 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).

    Kezelés: TTI-101 és Stereotactic body radiation therapy

  • TTI-101 + SBRT Dose Level -2A vizsgált kezelés

    * 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).

    Kezelés: TTI-101 és Stereotactic body radiation therapy

  • TTI-101 + SBRT Expansion PhaseA vizsgált kezelés

    * 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).

    Kezelés: TTI-101 és Stereotactic body radiation therapy

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Phase I/IB Trial of Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
A regiszteradat frissítve
2026. november 6.