Study of OMTX705 for Advanced Solid Tumors
This study is testing a new drug called OMTX705, both by itself and in combination with pembrolizumab, for people with advanced solid tumors. These are cancers that have spread or come back and for which standard treatments are no longer working or are not tolerated. The main goal is to see how safe OMTX705 is and what side effects it might cause. Researchers will also look at how well the treatment works. You may be able to join if you are 18 or older and have an advanced solid tumor. The study plans to enroll about 150 people.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves two groups: one receiving OMTX705 alone and another receiving OMTX705 with pembrolizumab. The study will gradually increase the dose of OMTX705 to find the safest and most effective amount.
- What's involved
- You would receive OMTX705 on Days 1 and 8 of each 21-day cycle. The study will involve regular safety evaluations.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be evaluated throughout the study, which is expected to last an average of 42 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05547321
Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.
Recruiting
PHASE1Ages 18+InterventionalOncomatryx Biopharma S.L.
~150 participants
Updated 2025-11-25 on ClinicalTrials.gov
What's tested:OMTX705PembrolizumabTislelizumab (BGB-A317)
At a glance
Recruiting sites
7 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety evaluation of OMTX705
Measured over Through study completion, an average of 42 months
Conditions
Where it's being run
9 sites across 7 statesBarcelona2
Madrid2
Massachusetts1
Galicia1
Guipúzcoa1
Navarre1
Spain1
Study leadership
- Ignacio García-Ribas, MD · STUDY_DIRECTOR · Oncomatryx Biopharm, S.L.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
SARC1 cohort: patients with locally advanced or metastatic FAP-positive sarcomas that have no standard therapeutic option with a proven clinical benefit or are intolerant to these therapies. FAP-positive is defined as expression of FAP with an H-score ≥40 or 2+/3+ in a tumor biopsy that can be either archival or fresh. FAP positivity will be considered exclusively on sarcoma cells and not in surrounding fibroblasts or other stromal cells. FAP measurement will be done in a central laboratory provided by the sponsor during the screening period (in countries where this is permitted). Alternatively, eligible patients may have had FAP quantified locally before enrolling the trial as part of the previous care of the patient. In the latter case, FAP will be re-quantified retrospectively in a central lab designated by the sponsor.
PDAC\_low and\_high cohorts: patients with metastatic PDAC who have received at least two and no more than four previous lines of systemic treatment for metastatic disease. If the patient received neoadjuvant/adjuvant therapy and recurred \<6 months after the last dose, this line will be counted as the first line for the metastatic disease.
SCHED1 cohort: patients with tumors meeting Part 1 definitions.
BIOPSY cohort: preferentially patients with metastatic CRC, esophageal cancer, GEJ cancer, gastric or NSCLC that have no standard therapeutic option with a proven clinical benefit or are intolerant to these therapies and volunteer for a fresh pre-treatment biopsy during the screening procedure and on-treatment biopsy. Other tumor histologies can be included after approval from the sponsor´s medical monitor. 3. Patients with tumors with actionable mutations should have progress to all approved and locally available targeted therapies or have them contraindicated. 4. Measurable disease by RECIST 1.1 on computerized tomography (CT), positron emission tomography (FDG-PET) or magnetic resonance (MRI) scan. Imaging tests outside the screening period are valid if performed not more than two weeks before consent signature and otherwise fulfil protocol criteria. In sites where available, FAPI-PET can be used but always with an associated CT. 5. Patients should have documented progression to the last line of therapy or, in the opinion of the investigator, require a change in the therapy. This latter option must be discussed and approved explicitly by the sponsor's medical monitor. 6. ECOG performance status 0-1. 7. Serum albumin ≥3.0 g/dL. 8. Adequate bone marrow, hepatic and renal function:
What this trial measures
- Safety evaluation of OMTX705Through study completion, an average of 42 months
Frequency by grade of treatment-emergent adverse events (TEAEs).