Advanced Solid TumorPhase 1NCT05547321
Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.
A Phase 1 study testing OMTX705, Pembrolizumab and Tislelizumab (BGB-A317) in people with Advanced Solid Tumor, run by Oncomatryx Biopharma S.L. at 9 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- OMTX705, Pembrolizumab and Tislelizumab (BGB-A317)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 20 Oct 2022to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 years and older.
- Part 1 monotherapy and combination: Patients with histologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven clinical benefit, or are intolerant to these therapies with any of the following selected tumor histologies: PDAC, gastric cancer (including gastroesophageal junction tumors), head and neck squamous-cell carcinoma (HNSCC), esophageal cancer, NSCLC, high grade serous ovarian cancer, primary peritoneal cancer, mesothelioma, BC, CRC, and FAP positive leiomyosarcoma or other FAP-positive sarcomas (with sponsor's approval). Patients with other tumor histologies may be enrolled with explicit sponsor's approval.
- Part 2:
- 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.
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- 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.
- Patients with tumors with actionable mutations should have progress to all approved and locally available targeted therapies or have them contraindicated.
- 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.
- 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.
- ECOG performance status 0-1.
- Serum albumin ≥3.0 g/dL.
- Adequate bone marrow, hepatic and renal function:
- Total bilirubin ≤1.5 times upper limit of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed).
- For Part 1 only: estimated creatinine clearance (CrCL) using the Cockcroft-Gault formula ≥60 mL/minute. Patients with calculated CrCL <60 mL/min can be enrolled if measured CrCL is ≥60 mL/min.
- For Part 2 only:, CrCL should be ≥30 mL/min.
- Hemoglobin ≥9 g/dL (whole or partial blood transfusions not allowed in the two previous weeks before enrollment).
- Absolute neutrophil count (ANC) ≥1.5 x 109/L (growth factors like G-CSF are not allowed in the two previous weeks before enrollment).
- Platelet count ≥75 x 109/L (platelet transfusions not allowed in the two previous weeks).
- Women of childbearing potential (WOCBP) (as defined in Appendix 3) and men with sexual partners who are WOCBP must be willing to adhere to contraceptive requirements as detailed in the protocol (Appendix 3) from at least one month prior to study entry to at least four months after the last dose of study treatment.
- Suitable venous access for safe drug administration and the study-required drug concentration and PD sampling.
- For Part 1 only: an archival biopsy for translational research should be available. If the archival biopsy is unavailable or does not have the requirements specified in the sample management plan, it can be replaced with a fresh biopsy. If the archival biopsy is unavailable and the fresh biopsy is not feasible, the medical monitor must approve explicitly the inclusion of the patient. Patients to be enrolled in Part 1 backfilling cohorts should consent for paired screening and on-treatment biopsies.
- For Part 2 only (Section 6.20.2):
- i.For patients with sarcoma in the cohort SARC1, an archival or fresh biopsy for FAP quantification during the screening period for eligibility is required.
- ii.For PDAClow, PDAChigh and BIOPSY cohorts, the patient must consent for fresh paired biopsies. NOTES: (i) In some exceptional circumstances, the medical monitor can waive the obtention of paired treatment biopsies upon request from the investigator. The rationale for the decision needs to be documented in writing. (ii) A patient receiving treatment can decline the on-treatment biopsy without providing any explanation and continue on study. If it is the investigator who decides to skip the on-treatment biopsy the rationale needs to be discussed with the medical monitor and documented in writing.
- iii.For patients enrolled in the SCHED1 cohort, paired fresh biopsies are desirable but voluntary.
Who cannot join
- Patients eligible for this study must not meet any of the following criteria:
- Treatment with systemic anticancer treatments, investigational products, or major surgery within four weeks before the first dose of study drug or five half-lives, whichever is shorter. Subjects should have recovered from previous treatment toxicity to Grade 1, baseline (except alopecia). Patients with endocrinopathies should have the replacement treatment in stable dosing.
- History of uncontrolled brain metastasis. Subjects with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and have new brain imaging confirming that brain metastasis are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either MRI or CT and considered controlled with <10 mg/day of prednisone-equivalent at the time of receiving the first dose of OMTX705. For asymptomatic subjects, screening brain imaging is not required.
- Patient has received extended field radiotherapy ≤four weeks before the start of treatment (≤one week for limited field radiation for palliation), and who has not recovered to Grade 1 or better from related side effects of such therapy (except for alopecia).
- Active infection requiring parenteral or oral antibiotics. Antibiotics given for prophylaxis are allowed. They are also allowed for minor localized infections like cystitis, tonsilitis or localized skin infections.
- Evidence of a serious uncontrolled medical disorder that, in the opinion of the investigator or medical monitor, makes it unwise for the subject to participate in the study or that might jeopardize compliance with the protocol.
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- Drainage of ascitic or pleural fluid two or more times in the 4 weeks prior to the first dose of study drug or permanent drain in place (e.g, PleurX®) for ascites or pleural effusion symptom management.
- Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or compromised ability to provide written informed consent.
- Clinical evidence of an active second invasive malignancy with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, breast ductal carcinoma in situ or localized non-melanoma skin cancers.
- Uncontrolled or significant cardiovascular disease defined by the New York Hearth Association (NYHA) classification III or IV.
- History of cerebrovascular stroke or myocardial infarction within the previous three months.
- Grade ≥2 peripheral neuropathy.
- Baseline QTc (using the Fridericia correction calculation) > 470 msec (unless pacemaker in place, only for patients in Part 2)
- Combination with pembrolizumab/tislelizumab: history of autoimmune disease requiring systemic immunosuppressive therapy (daily prednisone equivalent doses >10 mg/day).
- Combination with pembrolizumab/tislelizumab: patients who discontinued prior treatment with any immune checkpoint due to irAEs, irrespective of grade, recovery, or need for continued steroid therapy. Also, subjects without formal contraindication due to previous irAE with any immune checkpoint inhibitor (approved or investigational) are not eligible if the AE has not resolved to Grade 1 or better and/or still requires steroids (>10 mg of prednisone equivalent per day) for ongoing management.
- Combination with pembrolizumab/tislelizumab: patients with a history of pneumonitis/interstitial lung disease, patients who received live vaccines within 30 days of enrollment, and patients who discontinued prior immune checkpoint inhibitors due to Grade 2 myocarditis are excluded from enrollment into immune checkpoint inhibitor-containing cohorts.
- Known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. Note: Subjects who have positive hepatitis B surface antigen antibody can be included but must have an undetectable hepatitis B viral load.
- Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must meet the following criteria:
- have CD4+ T-cell (CD4+) counts ≥350 cells/μL.
- have not had an opportunistic infection within the past 12 months. Patients on prophylactic antimicrobials can be included in the trial.
- should be on established antiretroviral therapy for at least four weeks.
- have an HIV viral load of less than 400 copies/mL prior to enrollment.
- known history of any other relevant congenital or acquired immunodeficiency other than HIV infection.
- Known or suspected allergy to study treatment or related products, and specifically patients with a prior history of life-threatening reaction to polysorbate 20.
- Women who are pregnant or breastfeeding or trying to become pregnant.
- Male patients wishing fathering children, planning for future sperm banking, or expressing concerns about sterility.
- Patients requiring the concomitant administration of medications that are strong inhibitors or inducers of CYP3A4, 2D6, 1A2, 2C9, 2B6, and 2C19. In case they are taking any of these drugs (Appendix 4), they should be stopped at least 14 days prior to first dose.
- For Part 1 only: Only in particular circumstances it will be possible to enroll sarcoma patients with negative FAP expression on the surface of the tumor cells (central lab assessment) or without knowing FAP expression levels before C1D1. However, these cases must be discussed and explicitly approved by the sponsor´s medical monitor.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
Spain8 sites, 8 recruiting
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona
María Vieito, MD
- Recruiting
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona
Marta Gil Martín, MD
- Recruiting
Hospital 12 Octubre
Madrid, Madrid
Luis Paz-Ares, MD
- Recruiting
Hospital MD Anderson
Madrid, Madrid
Ricardo Cubedo, MD
- Recruiting
Clínica Universitaria de Navarra
Pamplona, Navarre
Mariano Ponz, MD
- Recruiting
Hospital Universitario de Donostia
San Sebastián, Guipúzcoa
Ane Areizaga, MD
- Recruiting
Onkologikoa
San Sebastián
Ander Urriticoechea, MD
- Not yet recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, 15706
Rafael López López, MD, +34 981 950 512, Rafael.Lopez.Lopez@sergas.es
Carolina García Martínez, SC, +34 981 950 512, cgarciamartinez.enf@gmail.com
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Bruno Bockorny, MD
About this study
Official title: Phase 1 Dose-escalation Trial of OMTX705, an Anti-fibroblast Activation Protein Antibody-drug Conjugate, as Single Agent and in Combination With Anti-PD-1 in Patients With Advanced Solid Tumors
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.
Read the detailed description
The study consists of 2 parts:
- Part 1: Phase 1 dose-escalation with two parallel staggered escalation cohorts: one cohort of patients treated with OMTX705 as monotherapy and one cohort of patients receiving escalating doses of OMTX705 in combination with standard pembrolizumab. The combination arm will start once OMTX705 monotherapy safety has been evaluated.
- Part 2: Five cohorts expansions have been projected to confirm the safety of OMTX705 as monotherapy (SCHED1, SARC1 and BIOPSY) and in combination with tislelizumab (PDAC_Low and PDAC_High) will provide additional efficacy and safety information.
For Part 1 (escalation phase) the classical 3+3 design will be followed to establish the maximum tolerated dose (MTD) or the provisional recommended dose for the Part 2 or expansion phase (RP2D). Three to six patients per treatment cohort will be assigned to receive sequentially higher doses of OMTX705 on Days 1 and 8 in cycles of 21 days. The OMTX705 starting dose is 1.0 mg/kg
Dose escalation will be based on a review of all parameters critical to subject safety from C1D1 to the start of C2D1. A safety report will be reviewed by the safty review committee (SRC) to determine if progression to the next planned dose level should occur or if additional subjects or lower dose levels are needed.
Expansion phase (Part 2): Based on the results observed in Part 1, five cohort expansions will provide additional safety and efficacy information and will support the selection of the RP2D and indications to be tested in future efficacy studies.
All patients allocated to receive OMTX705 in combination, will receive the anti-PD-1 tislelizumab. For this particular purpose the following cohorts will be opened:
- Cohort SARC1: OMTX705 in monotherapy at 10 mg/kg in sarcomas expressing FAP with H-score in cancer cells ≥40 or 2+/3+.
- Cohort PDAC_low: OMTX705 at 4.0 mg/kg in combination with tislelizumab in patients with stage IV PDAC.
- Cohort PDAC_high: OMTX705 at 7.5 mg/kg in combination with tislelizumab in patients with stage IV PDAC.
- Cohort SCHED1: Part 1 patient population to receive OMTX705 at 15 mg/kg in monotherapy on Day 1 every 21 days with the possibility to escalate up to 20 mg/kg.
- Cohort BIOPSY: patients with selected indications for which in Part 1 there are hints of antitumor activity who volunteer for paired fresh biopsies. They will receive OMTX705 at 7.5 mg/kg with tislelizumab.
After treatment discontinuation, patients will have the EoT visit 30 (±2) days after the last dose of any component of the treatment for the evaluation of new AEs or recovery from previous ones. EoT visit can be anticipated for patients scheduled to receive the next line of systemic treatment to the day of the start of the new therapy if this happens less than 30 days after the last dose of study treatment.
Subjects who discontinue study treatment for reasons other than progressive disease (PD) will continue to attend PFS Follow-up (FU) Visits every 12 (±1) weeks from the EoT Visit until the occurrence of PD, loss to follow up, consent withdrawal, death, the start of subsequent systemic antineoplastic therapy, or study termination, whichever occurs first.
Only patients enrolled in Part 2 will be followed for survival. To assess survival status, subjects will be contacted (which may be by phone or hospital visit, whichever is preferable) every 3 months from the first dose of OMTX705.
- Conditions
- Advanced Solid Tumor
- Being tested
- OMTX705, Pembrolizumab, Tislelizumab (BGB-A317)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMTX705Drug
The investigational product is OMTX705 administered as monotherapy at different escalation doses.
PembrolizumabDrug
Also called Keytruda (trademark)
Pembrolizumab at 200 mg administered in combination with different escalation doses of OMTX705.
OMTX705Drug
The investigational product is OMTX705 administered as monotherapy at 10 mg/kg
OMTX705Drug
The investigational product is OMTX705 administered as monotherapy at 15 mg/kg
OMTX705Drug
The investigational product is OMTX705 administered as monotherapy at 7.5 mg/kg
Tislelizumab (BGB-A317)Drug
Tislelizumab at 200 mg is administered in combination with OMTX705
OMTX705Drug
The investigational product is OMTX administered at 4.0 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy (OMTX705) | Experimental | Part 1: OMTX705 is administered as single agent at diffrent escalation doses. Receives: Drug: OMTX705 |
| Combination (OMTX705 + pembrolizumab) | Experimental | Part 1: OMTX705 at different escalation doses is administered in combination with pembrolizumab at 200 mg. Receives: Drug: OMTX705; Drug: Pembrolizumab |
| SARC1 | Experimental | Part 2: OMTX705 is administered as single agent in FAP positive patients at 10 mg/kg Receives: Drug: OMTX705 |
| PDAC Low | Experimental | Part 2: OMTX705 is administered at 4.0 mg/kg in combination with tislelizumab at 200 mg Receives: Drug: Tislelizumab (BGB-A317); Drug: OMTX705 |
| PDAC High | Experimental | Part 2: OMTX705 is administered at 7.5 mg/kg in combination with tislelizumab at 200 mg Receives: Drug: OMTX705; Drug: Tislelizumab (BGB-A317) |
| SCHED1 | Experimental | Part 2: OMTX705 is administered as single agent at 15 mg/kg Receives: Drug: OMTX705 |
| BIOPSY | Experimental | Part 2: OMTX705 is administered as single agent at 7.5 mg/kg Receives: Drug: OMTX705 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation of OMTX705
Frequency by grade of treatment-emergent adverse events (TEAEs).
Measured: Through study completion, an average of 42 months
Secondary outcomes (3)
Evaluation of the preliminary signs of antitumor activity of OMTX705 as monotherapy and in combination with pembrolizumab
By assessing the objective response rate (ORR) [complete response (CR) + partial response (PR)] per the Response Evaluation Criteria in Solid Tumors scale version 1.1 (RECIST 1.1)
Measured: Through study completion, an average of 42 months
Evaluation of the OMTX705 Pharmacokinetics
By assessing plasma drug concentrations of OMTX705 as monotherapy and with pembrolizumab/tislelizumab, with Ultra-High-Performance Liquid Chromatography (UPLC-MS/MS) and immunosorbent assay (ELISA) methods
Measured: Through study completion, an average of 42 months
Evaluation of OMTX705 Immunogenicity
By quantifying the formation of anti-drug antibodies (ADAs) with Meso Scale Discovery (MSD) immunoassay method.
Measured: Through study completion, an average of 42 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start20 Oct 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncomatryx Biopharma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro de Investigación del Cáncer Universidad de Salamanca, CTI Laboratory Services Spain, Anapharm Bioanalytics, Certara, Biotrial, Alcura Health España SA, Clinigen, Inc., Evidenze CRO, TFS Health Science, HistoOne, Opthimapharm
- Responsible party
- Sponsor
- Investigators
- Ignacio García-Ribas, MD, Study director, Oncomatryx Biopharm, S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547321
- Sponsor's protocol ID
- OMTX705-001
- Status last verified
- Nov 2025
- First submitted
- 2 Jun 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose-escalation Trial of OMTX705, an Anti-fibroblast Activation Protein Antibody-drug Conjugate, as Single Agent and in Combination With Anti-PD-1 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05547321
- Acronym / sponsor ID
- OMTX705-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oncomatryx Biopharma S.L.Industry (pharma, biotech, devices)
- Collaborators
- Centro de Investigación del Cáncer Universidad de Salamanca, CTI Laboratory Services Spain, Anapharm Bioanalytics, Certara, Biotrial, Alcura Health España SA, Clinigen, Inc., Evidenze CRO, TFS Health Science, HistoOne, Opthimapharm
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study consists of 2 parts:
- Part 1: Phase 1 dose-escalation with two parallel staggered escalation cohorts: one cohort of patients treated with OMTX705 as monotherapy and one cohort of patients receiving escalating doses of OMTX705 in combination with standard pembrolizumab. The combination arm will start once OMTX705 monotherapy safety has been evaluated.
- Part 2: Five cohorts expansions have been projected to confirm the safety of OMTX705 as monotherapy (SCHED1, SARC1 and BIOPSY) and in combination with tislelizumab (PDAC_Low and PDAC_High) will provide additional efficacy and safety information.
For Part 1 (escalation phase) the classical 3+3 design will be followed to establish the maximum tolerated dose (MTD) or the provisional recommended dose for the Part 2 or expansion phase (RP2D). Three to six patients per treatment cohort will be assigned to receive sequentially higher doses of OMTX705 on Days 1 and 8 in cycles of 21 days. The OMTX705 starting dose is 1.0 mg/kg
Dose escalation will be based on a review of all parameters critical to subject safety from C1D1 to the start of C2D1. A safety report will be reviewed by the safty review committee (SRC) to determine if progression to the next planned dose level should occur or if additional subjects or lower dose levels are needed.
Expansion phase (Part 2): Based on the results observed in Part 1, five cohort expansions will provide additional safety and efficacy information and will support the selection of the RP2D and indications to be tested in future efficacy studies.
All patients allocated to receive OMTX705 in combination, will receive the anti-PD-1 tislelizumab. For this particular purpose the following cohorts will be opened:
- Cohort SARC1: OMTX705 in monotherapy at 10 mg/kg in sarcomas expressing FAP with H-score in cancer cells ≥40 or 2+/3+.
- Cohort PDAC_low: OMTX705 at 4.0 mg/kg in combination with tislelizumab in patients with stage IV PDAC.
- Cohort PDAC_high: OMTX705 at 7.5 mg/kg in combination with tislelizumab in patients with stage IV PDAC.
- Cohort SCHED1: Part 1 patient population to receive OMTX705 at 15 mg/kg in monotherapy on Day 1 every 21 days with the possibility to escalate up to 20 mg/kg.
- Cohort BIOPSY: patients with selected indications for which in Part 1 there are hints of antitumor activity who volunteer for paired fresh biopsies. They will receive OMTX705 at 7.5 mg/kg with tislelizumab.
After treatment discontinuation, patients will have the EoT visit 30 (±2) days after the last dose of any component of the treatment for the evaluation of new AEs or recovery from previous ones. EoT visit can be anticipated for patients scheduled to receive the next line of systemic treatment to the day of the start of the new therapy if this happens less than 30 days after the last dose of study treatment.
Subjects who discontinue study treatment for reasons other than progressive disease (PD) will continue to attend PFS Follow-up (FU) Visits every 12 (±1) weeks from the EoT Visit until the occurrence of PD, loss to follow up, consent withdrawal, death, the start of subsequent systemic antineoplastic therapy, or study termination, whichever occurs first.
Only patients enrolled in Part 2 will be followed for survival. To assess survival status, subjects will be contacted (which may be by phone or hospital visit, whichever is preferable) every 3 months from the first dose of OMTX705.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Monotherapy (OMTX705) | Experimental | Drug: OMTX705Part 1: OMTX705 is administered as single agent at diffrent escalation doses. |
| Combination (OMTX705 + pembrolizumab) | Experimental | Drug: OMTX705, Drug: PembrolizumabPart 1: OMTX705 at different escalation doses is administered in combination with pembrolizumab at 200 mg. |
| SARC1 | Experimental | Drug: OMTX705Part 2: OMTX705 is administered as single agent in FAP positive patients at 10 mg/kg |
| PDAC Low | Experimental | Drug: Tislelizumab (BGB-A317), Drug: OMTX705Part 2: OMTX705 is administered at 4.0 mg/kg in combination with tislelizumab at 200 mg |
| PDAC High | Experimental | Drug: OMTX705, Drug: Tislelizumab (BGB-A317)Part 2: OMTX705 is administered at 7.5 mg/kg in combination with tislelizumab at 200 mg |
| SCHED1 | Experimental | Drug: OMTX705Part 2: OMTX705 is administered as single agent at 15 mg/kg |
| BIOPSY | Experimental | Drug: OMTX705Part 2: OMTX705 is administered as single agent at 7.5 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Male and female patients aged 18 years and older.
- Part 1 monotherapy and combination: Patients with histologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven clinical benefit, or are intolerant to these therapies with any of the following selected tumor histologies: PDAC, gastric cancer (including gastroesophageal junction tumors), head and neck squamous-cell carcinoma (HNSCC), esophageal cancer, NSCLC, high grade serous ovarian cancer, primary peritoneal cancer, mesothelioma, BC, CRC, and FAP positive leiomyosarcoma or other FAP-positive sarcomas (with sponsor's approval). Patients with other tumor histologies may be enrolled with explicit sponsor's approval.
- Patients with tumors with actionable mutations should have progress to all approved and locally available targeted therapies or have them contraindicated.
- 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.
- 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.
Key exclusion criteria (28 listed)
- Treatment with systemic anticancer treatments, investigational products, or major surgery within four weeks before the first dose of study drug or five half-lives, whichever is shorter. Subjects should have recovered from previous treatment toxicity to Grade 1, baseline (except alopecia). Patients with endocrinopathies should have the replacement treatment in stable dosing.
- History of uncontrolled brain metastasis. Subjects with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and have new brain imaging confirming that brain metastasis are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either MRI or CT and considered controlled with <10 mg/day of prednisone-equivalent at the time of receiving the first dose of OMTX705. For asymptomatic subjects, screening brain imaging is not required.
- Patient has received extended field radiotherapy ≤four weeks before the start of treatment (≤one week for limited field radiation for palliation), and who has not recovered to Grade 1 or better from related side effects of such therapy (except for alopecia).
- Active infection requiring parenteral or oral antibiotics. Antibiotics given for prophylaxis are allowed. They are also allowed for minor localized infections like cystitis, tonsilitis or localized skin infections.
- Evidence of a serious uncontrolled medical disorder that, in the opinion of the investigator or medical monitor, makes it unwise for the subject to participate in the study or that might jeopardize compliance with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMTX705The investigational product is OMTX705 administered as monotherapy at different escalation doses. | Drug | Combination (OMTX705 + pembrolizumab), Monotherapy (OMTX705) |
| PembrolizumabAlso: Keytruda (trademark)Pembrolizumab at 200 mg administered in combination with different escalation doses of OMTX705. | Drug | Combination (OMTX705 + pembrolizumab) |
| OMTX705The investigational product is OMTX705 administered as monotherapy at 10 mg/kg | Drug | SARC1 |
| OMTX705The investigational product is OMTX705 administered as monotherapy at 15 mg/kg | Drug | SCHED1 |
| OMTX705The investigational product is OMTX705 administered as monotherapy at 7.5 mg/kg | Drug | BIOPSY, PDAC High |
| Tislelizumab (BGB-A317)Tislelizumab at 200 mg is administered in combination with OMTX705 | Drug | PDAC High, PDAC Low |
| OMTX705The investigational product is OMTX administered at 4.0 mg/kg | Drug | PDAC Low |
Primary outcome
Safety evaluation of OMTX705
Time frame: Through study completion, an average of 42 months
Frequency by grade of treatment-emergent adverse events (TEAEs).
3 secondary outcomes
Evaluation of the preliminary signs of antitumor activity of OMTX705 as monotherapy and in combination with pembrolizumab
Time frame: Through study completion, an average of 42 months
Evaluation of the OMTX705 Pharmacokinetics
Time frame: Through study completion, an average of 42 months
Evaluation of OMTX705 Immunogenicity
Time frame: Through study completion, an average of 42 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ignacio García-Ribas, MD study director
Oncomatryx Biopharm, S.L.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OMTX705, Pembrolizumab and Tislelizumab (BGB-A317) in people with Advanced Solid Tumor, run by Oncomatryx Biopharma S.L. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignacio García-Ribas, MD (+34 946 08 70 37, igarcia@oncomatryx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation of OMTX705 (time frame: Through study completion, an average of 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.