Clinical Trial of OMTX705 for Advanced Pancreatic Cancer
This study is testing a new drug called OMTX705 in combination with standard treatments (gemcitabine/nab-paclitaxel and tislelizumab) for advanced or metastatic pancreatic adenocarcinoma (a type of pancreatic cancer that has spread). OMTX705 is an antibody-drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells. The main goal of this first part of the study is to find a safe dose of OMTX705 when given with these other medications. You may be able to join if you have advanced pancreatic cancer and are at least 18 years old. The study is looking at side effects and changes in body temperature to determine the best dose. The current recruitment status is unclear.
- Study design
- This is a Phase 1b dose escalation trial with a 3+3 design, meaning small groups of participants will receive increasing doses of OMTX705. It is designed to enroll 69 participants.
- What's involved
- You would receive OMTX705, nab-paclitaxel, gemcitabine, and/or tislelizumab intravenously (through a vein) on specific days in 21-day cycles. You would have visits for monitoring side effects and body temperature.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for treatment-emergent adverse events (side effects) up to 90 days after the last dose of study 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.
Clinical Trial of OMTX705 in Combination With Gemcitabine/Nab-Paclitaxel and Tislelizumab in Patients With Advanced/Metastatic Pancreatic Adenocarcinoma
At a glance
Conditions
NCT07377045
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusettsstudy coordinator listed
Not yet recruiting
Clinica Universidad de Navarra (CUN)
Pamplona, Spainstudy coordinator listed
Recruiting
Hospital Clínico Universitario de Santiago - CHUS
Santiago de Compostela, Spainstudy coordinator listed
Not yet recruiting
Hospital Universitario 12 Octubre
Madrid, Spainstudy coordinator listed
Recruiting
Hospital Universitario Donostia
Donostia / San Sebastian, Spainstudy coordinator listed
Not yet recruiting
Hospital Universitario Vall d'Hebron (VHIO)
Barcelona, Spainstudy coordinator listed
Not yet recruiting
ICO- Hospitalet Catalan Institute of Oncology
L'Hospitalet de Llobregat, Spainstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Number of participants with dose limiting toxicities (DLTs) during Part 1 of the studyAt Day 1, Day 8 and Day 15 of the first 21-day cycle, and up to Day 1 of the second 21-day cycle.
The nature and frequency of DLTs will be assessed.
- Number of participants with treatment emergent adverse events (TEAEs) during Part 1 of the studyFrom Screening visit through EoT visit (up to 90±5 days after the last dose of study treatment)
A TEAE is an AE that occurs from the first administration of the study drug up to EoT visit. They can be related to the study drug or not. Frequency, duration, and severity (per CTCAE v.5.0) of TEAEs will be assessed.
- Changes in body temperature during Part 1 of the studyAt Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months).
Body temperature should be monitored during each infusion of OMTX705 as follows: on Cycle 1 and 2 before administration and every 30 (±5) minutes thereafter up to 1h ±5 minutes after the end of the infusion (EoI). From Cycle 3 onwards, it will be measured only at OMTX705 pre-dose and in case of clinical symptoms of an infusion-related reaction to document the AE.
- Changes in blood pressure (BP) during Part 1 of the studyAt Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months).
BP will be measured in the sitting position after 5 minutes of rest. BP should be monitored during each infusion of OMTX705 as follows: on Cycle 1 and 2 before administration and every 30 (±5) minutes thereafter up to 1h ±5 minutes after the end of the infusion (EoI). From Cycle 3 onwards, it will be measured only at OMTX705 pre-dose and in case of clinical symptoms of an infusion-related reaction to document the AE.
- Changes in pulse rate during Part 1 of the studyAt Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months).
Pulse rate will be measured in the sitting position after 5 minutes of rest. Pulse rate should be monitored during each infusion of OMTX705 as follows: on Cycle 1 and 2 before administration and every 30 (±5) minutes thereafter up to 1h ±5 minutes after the end of the infusion (EoI). From Cycle 3 onwards, it will be measured only at OMTX705 pre-dose and in case of clinical symptoms of an infusion-related reaction to document the AE.
- Changes in electrocardiogram (ECG) PR interval during Part 1 of the studyAt Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months).
Changes in ECG assessed using a 12-lead ECG machine. In Cycle 1 and Cycle 2 ECGs will be recorded before the start of OMTX705 infusion and after the end of infusion (+15 minutes).
- Changes in electrocardiogram (ECG) QRS interval during Part 1 of the studyAt Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months).
Changes in ECG assessed using a 12-lead ECG machine. In Cycle 1 and Cycle 2 ECGs will be recorded before the start of OMTX705 infusion and after the end of infusion (+15 minutes).
- Changes in electrocardiogram (ECG) QT interval during Part 1 of the studyAt Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months).
Changes in ECG assessed using a 12-lead ECG machine. In Cycle 1 and Cycle 2 ECGs will be recorded before the start of OMTX705 infusion and after the end of infusion (+15 minutes).
- Changes in electrocardiogram (ECG) Fridericia correction QT (QTcF) interval during Part 1 of the studyAt Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months).
Changes in ECG assessed using a 12-lead ECG machine. In Cycle 1 and Cycle 2 ECGs will be recorded before the start of OMTX705 infusion and after the end of infusion (+15 minutes).
- Changes in concentration of serum chemistry parameters during Part 1 of the studyAt Screening visit, at Day 1, Day 8 and Day 15 of the two first 21-day cycles, and at Day 1 and Day 8 of the subsequent 21-day cycles until treatment discontinuation (average of 4 months).
The following laboratory parameters will be measured for serum chemistry: albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (ALP), total bilirubin, calcium, creatinine, magnesium, potassium, sodium, lactate dehydrogenase, C-reactive protein, creatine phosphokinase and glucose. Chemistry C1D1 blood samples may be collected within 3 days before dosing to ensure participant eligibility. If screening clinical laboratory testing was performed within 3 days before the C1D1 dose, it does not need to be repeated. Chemistry blood samples will be obtained weekly for the first 2 cycles (Day 1, 8 and 15 of Cycle 1 and Cycle 2). From Cycle 3, chemistry will be collected only on the administration days (Day 1 and Day 8). Samples can be collected and analyzed the day before.
- Changes in concentration of hematology parameters during Part 1 of the studyAt Screening visit, at Day 1, Day 8 and Day 15 of the two first 21-day cycles, and at Day 1 and Day 8 of the subsequent 21-day cycles until treatment discontinuation (average of 4 months).
The following laboratory parameters will be measured for hematology: hemoglobin, platelet count, red blood cell count , white blood cells (WBC) count and differential WBC count (absolute number). Hematology C1D1 blood samples may be collected within 3 days before dosing to ensure participant eligibility. If screening clinical laboratory testing was performed within 3 days before the C1D1 dose, it does not need to be repeated. Hematology blood samples will be obtained weekly for the first 2 cycles (Day 1, 8 and 15 of Cycle 1 and Cycle 2). From Cycle 3, hematology will be collected only on the administration days (Day 1 and Day 8). Samples can be collected and analyzed the day before.
- Treatment modifications during Part 1 of the studyFrom Screening visit and through the study until treatment discontinuation (average of 4 months).
Treatment modifications are measured as percentage of relative dose intensity.
- Definition of Maximum tolerated dose (MTD) for Part 2From Screening visit and through the study until treatment discontinuation (average of 4 months).
MTD definition for Part 2: recommended dose will be based on MTD, or in absence of MTD based on non-DLT safety, efficacy as well as other relevant pharmacokinetics/pharmacodynamics evaluations.
- Objective response rate (ORR) during Part 2 of the studyFrom Screening visit through EoT1 visit (30 ±2 days after the last dose of study treatment)
The ORR is defined as the proportion of participants who have a confirmed partial response (PR) or complete response (CR) to study treatment per RECIST v1.1 as determined by the investigator.