Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.

NCT05547321 | Recruiting Phase 1 FDA Drug

• 1 other identifier: OMTX705-001
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 9

Brief 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 therapeutic option.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Safety evaluation of OMTX705

  Frequency by grade of treatment-emergent adverse events (TEAEs).

  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

  Through study completion, an average of 42 months

• Evaluation of the OMTX705 Pharmacokinetics

  Through study completion, an average of 42 months

• Evaluation of OMTX705 Immunogenicity

  Through study completion, an average of 42 months.

Other Outcomes (6)

• Evaluation of standard cancer serum biomarkers

  Through study completion, an average of 42 months

• Evaluation of OMTX705 biomarkers

  Through study completion, an average of 42 months.

• Evaluation of OMTX705 payload metabolites

  Through study completion, an average of 42 months.

Study Arms (7)

Monotherapy (OMTX705)

EXPERIMENTAL

Part 1: OMTX705 is administered as single agent at diffrent escalation doses.

Drug: OMTX705

Combination (OMTX705 + pembrolizumab)

EXPERIMENTAL

Part 1: OMTX705 at different escalation doses is administered in combination with pembrolizumab at 200 mg.

Drug: OMTX705; Drug: Pembrolizumab

SARC1

EXPERIMENTAL

Part 2: OMTX705 is administered as single agent in FAP positive patients at 10 mg/kg

Drug: OMTX705

PDAC Low

EXPERIMENTAL

Part 2: OMTX705 is administered at 4.0 mg/kg in combination with tislelizumab at 200 mg

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

Drug: OMTX705; Drug: Tislelizumab (BGB-A317)

SCHED1

EXPERIMENTAL

Part 2: OMTX705 is administered as single agent at 15 mg/kg

Drug: OMTX705

BIOPSY

EXPERIMENTAL

Part 2: OMTX705 is administered as single agent at 7.5 mg/kg

Drug: OMTX705

Interventions

Pembrolizumab DRUG

Pembrolizumab at 200 mg administered in combination with different escalation doses of OMTX705.

Also known as: Keytruda (trademark)

Combination (OMTX705 + pembrolizumab)

OMTX705 DRUG

The investigational product is OMTX705 administered as monotherapy at different escalation doses.

Combination (OMTX705 + pembrolizumab); Monotherapy (OMTX705)

Tislelizumab (BGB-A317) DRUG

Tislelizumab at 200 mg is administered in combination with OMTX705

PDAC High; PDAC Low

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Oncomatryx Biopharma S.L.: lead
• Centro de Investigación del Cáncer Universidad de Salamanca: collaborator
• CTI Laboratory Services Spain: collaborator
• Anapharm Bioanalytics: collaborator
• Certara: collaborator
• Biotrial: collaborator
• Alcura Health España SA: collaborator
• Clinigen, Inc.: collaborator
• Evidenze: collaborator
• TFS Health Science: collaborator
• HistoOne: collaborator
• Opthimapharm: collaborator

Study Sites (9)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

NOT YET RECRUITING

ICO L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Galicia, 15706, Spain

NOT YET RECRUITING

Hospital Universitario de Donostia

San Sebastián, Guipúzcoa, Spain

RECRUITING

Hospital 12 Octubre

Madrid, Madrid, Spain

RECRUITING

Hospital MD Anderson

Madrid, Madrid, Spain

RECRUITING

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

RECRUITING

Onkologikoa

San Sebastián, Spain

RECRUITING

MeSH Terms

Interventions

pembrolizumab; Patents as Topic; tislelizumab

Intervention Hierarchy (Ancestors)

Intellectual Property; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations

Study Officials

• Ignacio García-Ribas, MD

  Oncomatryx Biopharm, S.L.

  STUDY DIRECTOR

Central Study Contacts

Ignacio García-Ribas, MD

CONTACT

+34 946 08 70 37; igarcia@oncomatryx.com

Susana Román

CONTACT

+34 946 08 70 37; sroman@oncomatryx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: September 21, 2022
• Study Start: October 20, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1); ES (8)