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● Recruiting
Clinical Trial of OMTX705 in Combination With Gemcitabine/Nab-Paclitaxel and Tislelizumab in Patients With Advanced/Metastatic Pancreatic Adenocarcinoma
Condition: Pancreatic Adenocarcinoma Metastatic · Sponsor: Oncomatryx Biopharma S.L.
About this study
This is a Phase 1b dose escalation trial of OMTX705, an anti-fibroblast activation protein (FAP) antibody-drug conjugate (ADC), in combination with gemcitabine/nab-paclitaxel and tislelizumab in patients with advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). The trial will be conducted in two parts (Part 1 and Part 2). Both parts will enroll participants with advanced PDAC that, in general, are eligible to receive gemcitabine/nab-paclitaxel. Part 1 is intended to determine the safe recommended dose of OMTX705 in combination with gemcitabine/nab-paclitaxel (1A) and in combination with gemcitabine/nab-paclitaxel+tislelizumab (1B). Both 1A and 1B will enroll in a standard 3+3 design. Only one dose level of OMTX705 will be selected for Part 2 by a Data Safety Monitoring Board (DSMB). In Part 2, 3 parallel randomized arms will be opened simultaneously with 1:1:1 randomization (N=15 each): OMTX705+gemcitabine/nab-paclitaxel (arm 2A), OMTX705+tislelizumab+gemcitabine/nab-paclitaxel (arm 2B) and gemcitabine/nab-paclitaxel (arm 2C, reference arm).
This description comes directly from the study's public registry record.
Talk to the study team
Ignacio García Ribas, Chief Medical Officer · 0034 946 08 70 37 · igarcia@oncomatryx.com
Susana Román, Clinical Operations Director · 0034 946008 70 37 · sroman@oncomatryx.com
Always discuss trial participation with your own doctor first.
Locations (7)
| Beth Israel Deaconess Medical Center (BIDMC) | Boston, Massachusetts, United States | Not Yet Recruiting |
| Hospital Universitario Vall d'Hebron (VHIO) | Barcelona, Spain | Not Yet Recruiting |
| Hospital Universitario Donostia | Donostia / San Sebastian, Spain | Not Yet Recruiting |
| ICO- Hospitalet Catalan Institute of Oncology | L'Hospitalet de Llobregat, Spain | Recruiting |
| Hospital Universitario 12 Octubre | Madrid, Spain | Recruiting |
| Clinica Universidad de Navarra (CUN) | Pamplona, Spain | Recruiting |
| Hospital Clínico Universitario de Santiago - CHUS | Santiago de Compostela, Spain | Not Yet Recruiting |
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