Actively Recruiting
Clinical Trial of OMTX705 in Combination With Gemcitabine/Nab-Paclitaxel and Tislelizumab in Patients With Advanced/Metastatic Pancreatic Adenocarcinoma
Led by Oncomatryx Biopharma S.L. · Updated on 2026-01-29
69
Participants Needed
7
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Clinical Trial of OMTX705 in Combination With Gemcitabine/Nab-Paclitaxel and Tislelizumab in Patients With Advanced/Metastatic Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent
- Male or female aged 18 years or older
- Confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC), metastatic or non-resectable locoregional as specified
- May have had no more than one prior line of systemic chemotherapy
- Suitable for standard gemcitabine and nab-paclitaxel treatment
- Measurable disease by imaging following RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Adequate bone marrow, liver, and kidney function with specific lab value thresholds
- Women of childbearing potential and men with partners must agree to use effective contraception during and after the study
- Suitable venous access for treatment and sample collection
- Availability of archival tumor tissue sample
- Fresh biopsy required in Part 2 unless medically contraindicated
You will not qualify if you...
- Prior treatment with OMTX705 or nab-paclitaxel for metastatic disease
- Recent systemic anticancer treatment, investigational drugs, or major surgery within 4 weeks before starting study drug
- Uncontrolled brain metastases or unstable brain lesions
- Recent extended field radiotherapy or insufficient recovery from related side effects
- Major surgery or significant trauma within 21 days before consent
- Cardiac arrhythmias needing anti-arrhythmic drugs (except pacemakers, beta blockers, digoxin)
- Active infection requiring antibiotics (prophylactic or minor infections allowed)
- Serious uncontrolled medical disorders
- Frequent ascitic or pleural fluid drainage or permanent drains
- Recent biliary procedures within 7 days before treatment
- Psychiatric or social conditions limiting study compliance
- Other cancers within past 3 years except certain treated early-stage cancers
- Severe cardiovascular disease (NYHA class III or IV)
- Stroke or heart attack within last 3 months
- Peripheral neuropathy of Grade 2 or higher
- Live vaccine within 30 days before treatment
- Active hepatitis B or C infection
- Known allergy to study drugs or polysorbate 20
- Pregnant or breastfeeding women, or men planning to father children
- Use of strong CYP450 enzyme inhibitors or inducers
- History of autoimmune disease needing systemic immunosuppressants (except Part 1A)
- Prior immune checkpoint therapy discontinuation due to adverse events (except Part 1A)
- History of pneumonitis, interstitial lung disease, or Grade 2 myocarditis related to immune therapies (except Part 1A)
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
Hospital Universitario Vall d'Hebron (VHIO)
Barcelona, Spain, 08035
Not Yet Recruiting
3
Hospital Universitario Donostia
Donostia / San Sebastian, Spain, 20014
Not Yet Recruiting
4
ICO- Hospitalet Catalan Institute of Oncology
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
5
Hospital Universitario 12 Octubre
Madrid, Spain, 28041
Actively Recruiting
6
Clinica Universidad de Navarra (CUN)
Pamplona, Spain, 31008
Actively Recruiting
7
Hospital Clínico Universitario de Santiago - CHUS
Santiago de Compostela, Spain, 15706
Not Yet Recruiting
Research Team
I
Ignacio García Ribas, Chief Medical Officer
CONTACT
S
Susana Román, Clinical Operations Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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