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NCT07377045 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial of OMTX705 in Combination With Gemcitabine/Nab-Paclitaxel and Tislelizumab in Patients With Advanced/Metastatic Pancreatic Adenocarcinoma
A Phase 1 study of Pancreatic Adenocarcinoma Metastatic, sponsored by Oncomatryx Biopharma S.L..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
- 7
- Study locations
NCT07377045: Recruiting Phase 1 study of Pancreatic Adenocarcinoma Metastatic, sponsored by Oncomatryx Biopharma S.L..
NCT07377045 is a Phase 1 study of Pancreatic Adenocarcinoma Metastatic that is actively recruiting participants, run by Oncomatryx Biopharma S.L.. The registered enrollment target is 69 participants, above the 45-participant average among 5 other Pancreatic Adenocarcinoma Metastatic trials with a reported enrollment target (53% higher). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07377045, a Phase 1 study of Pancreatic Adenocarcinoma Metastatic, is actively recruiting participants, sponsored by Oncomatryx Biopharma S.L..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
- 7
- Study locations
Study Summary
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).
Primary Outcome
The nature and frequency of DLTs will be assessed.
Conditions Studied
Interventions
- DRUG Nab-paclitaxel + Gemcitabine
- DRUG OMTX705
- DRUG Tislelizumab (i.v. 200mg)
Study Locations (7)
Other
- Hospital Universitario Vall d'Hebron (VHIO) - Barcelona
- Hospital Universitario Donostia - Donostia / San Sebastian
- ICO- Hospitalet Catalan Institute of Oncology - L'Hospitalet de Llobregat
- Hospital Universitario 12 Octubre - Madrid
- Clinica Universidad de Navarra (CUN) - Pamplona
- Hospital Clínico Universitario de Santiago - CHUS - Santiago de Compostela
Massachusetts
- Beth Israel Deaconess Medical Center (BIDMC) - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2025-10-28 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
What NCT07377045 shows while recruiting
NCT07377045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 45-participant average among 5 other Pancreatic Adenocarcinoma Metastatic trials with a reported enrollment target (53% higher).
The record links to 1 condition, with Pancreatic Adenocarcinoma Metastatic appearing as the primary indexed condition, and to 3 interventions - of which Nab-paclitaxel + Gemcitabine is the first listed.
NCT07377045 lists 7 locations in 2 states (Other, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT07377045 about?
NCT07377045 is a clinical study titled "Clinical Trial of OMTX705 in Combination With Gemcitabine/Nab-Paclitaxel and Tislelizumab in Patients With Advanced/Metastatic Pancreatic Adenocarcinoma". 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 i...
What is the current status of trial NCT07377045?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2025-10-28. Estimated completion is 2029-03.
What conditions does trial NCT07377045 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma Metastatic.
What interventions are being tested in trial NCT07377045?
The interventions under investigation include: Nab-paclitaxel + Gemcitabine (DRUG), OMTX705 (DRUG), Tislelizumab (i.v. 200mg) (DRUG).
Who is sponsoring clinical trial NCT07377045?
This trial is sponsored by Oncomatryx Biopharma S.L., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07377045 being conducted?
This trial has 7 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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