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Tests treatment safety and results for Advanced Solid Tumor
Official title Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT05547321
What this study is testing
What is OMTX705?
OMTX705 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- SARC1 cohort: patients with locally advanced or metastatic FAP-positive sarcomas that have no standard therapeutic option with a proven clinical...
- 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...
- SCHED1 cohort: patients with tumors meeting Part 1 definitions.
You likely can't join 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...
- History of uncontrolled brain metastasis. people with brain metastases are allowed if they are previously treated with surgery, whole-brain...
- Patient has received extended field radiotherapy ≤four weeks before the start of treatment (≤one week for limited field radiation for palliation)...
- Active infection requiring parenteral or oral antibiotics. Antibiotics given for prophylaxis are allowed. They are also allowed for minor localized...
- Evidence of a serious uncontrolled medical disorder that, in the opinion of the investigator or medical monitor, makes it unwise for the subject to...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 PDAC\_low, PDAC\_high...
What rules you out
- 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. people should have recovered from...
- History of uncontrolled brain metastasis. people with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and have new brain imaging confirming...
- 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...
- 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...
- 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, people...
- 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...
- Known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. Note: people who have positive hepatitis B surface antigen antibody can be included but must have an undetectable...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Barcelona, Barcelona, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Santiago de Compostela, Galicia, Spain
- San Sebastián, Guipúzcoa, Spain
- Madrid, Madrid, Spain
- Pamplona, Navarre, Spain
- San Sebastián, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Barcelona, Barcelona, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Santiago de Compostela, Galicia, Spain; San Sebastián, Guipúzcoa, Spain; Madrid, Madrid, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.