Actively Recruiting
Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.
Led by Oncomatryx Biopharma S.L. · Updated on 2025-11-25
150
Participants Needed
9
Research Sites
266 weeks
Total Duration
On this page
Sponsors
O
Oncomatryx Biopharma S.L.
Lead Sponsor
C
Centro de Investigación del Cáncer Universidad de Salamanca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Open-label, two parallel arm, multicenter, Phase 1 dose-escalation study to evaluate the safety and tolerability of OMTX705, both as monotherapy or in combination with pembrolizumab (Part 1) or tislelizumab (Part 2) in the treatment of patients with advanced or metastatic cancer in whom there is no available standard therapeutic option.
CONDITIONS
Official Title
Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 years and older
- Histologically confirmed advanced or metastatic solid tumors without standard effective treatment, including specific tumor types such as pancreatic, gastric, head and neck, lung, ovarian, mesothelioma, breast, colorectal, and FAP-positive sarcomas
- For certain cohorts, specific tumor characteristics such as FAP expression or prior lines of treatment are required
- Measurable disease by imaging scans within 2 weeks before consent
- Documented disease progression or need for therapy change approved by medical monitor
- ECOG performance status of 0 or 1
- Serum albumin level of at least 3.0 g/dL
- Adequate bone marrow, liver, and kidney function as defined by lab criteria
- Women of childbearing potential and men with partners must agree to contraception requirements
- Suitable venous access for drug administration and sample collection
- Availability of tumor biopsy samples for research, either archival or fresh, depending on study part and cohort
- Patients with tumors with actionable mutations must have progressed on or be contraindicated for approved targeted therapies
You will not qualify if you...
- Treatment with systemic anticancer therapy, investigational drugs, or major surgery within 4 weeks before study drug or five half-lives, whichever is shorter
- Uncontrolled brain metastases or recent unstable brain lesions
- Recent radiotherapy within 4 weeks (or 1 week for limited field) without recovery to mild or no side effects
- Active infection requiring antibiotic treatment (except minor localized infections)
- Serious uncontrolled medical disorders or conditions that impair study compliance
- Frequent drainage or permanent drainage devices for ascitic or pleural fluid
- Psychiatric or social conditions limiting informed consent or study compliance
- Active second invasive cancers except certain stable or in situ cancers
- Severe cardiovascular disease (NYHA class III or IV)
- Recent stroke or myocardial infarction within 3 months
- Moderate or worse peripheral neuropathy
- Prolonged QTc interval above 470 msec unless pacemaker present (Part 2)
- History of autoimmune disease requiring systemic immunosuppression for combination therapy cohorts
- Prior discontinuation of immune checkpoint inhibitors due to immune-related adverse events
- History of pneumonitis, recent live vaccines, or myocarditis for combination therapy cohorts
- Hepatitis B or C infection with detectable viral load
- Known allergy to study drugs or related products
- Pregnant or breastfeeding women, or men planning fatherhood or sperm banking
- Use of strong inhibitors or inducers of specific liver enzymes within 14 days before dosing
- For Part 1, sarcoma patients without confirmed FAP expression require special approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Not Yet Recruiting
3
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Actively Recruiting
4
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain, 15706
Not Yet Recruiting
5
Hospital Universitario de Donostia
San Sebastián, Guipúzcoa, Spain
Actively Recruiting
6
Hospital 12 Octubre
Madrid, Madrid, Spain
Actively Recruiting
7
Hospital MD Anderson
Madrid, Madrid, Spain
Actively Recruiting
8
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Actively Recruiting
9
Onkologikoa
San Sebastián, Spain
Actively Recruiting
Research Team
I
Ignacio García-Ribas, MD
CONTACT
S
Susana Román
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
7
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