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New treatment option for Pancreatic Adenocarcinoma Metastatic
Official title Clinical Trial of OMTX705 in Combination With Gemcitabine/Nab-Paclitaxel and Tislelizumab in Patients With Advanced/Metastatic Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT07377045
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 pancreatic adenocarcinoma metastatic.
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
- This is a Phase 1b dose escalation trial of OMTX705, an anti-fibroblast activation protein (FAP) antibody-drug conjugate (ADC), in combination with gemcitabine/nab-paclitaxel and tislelizumab in patients with advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). The trial will be conducted in two parts (Part 1 and Part 2).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Capable of giving signed informed consent.
- Male and female participant aged 18 years and older.
- Participants must have histologically or cytologically confirmed PDAC: a) Metastatic PDAC who have not received therapy or received 1 prior line of...
- Participants should have documented disease progression if previously locally advanced disease or be in 2nd line for stage IV or, in the opinion of...
- Participants should be considered in general eligible for standard GA, for first or second line for metastatic disease (Part 1 and 2) or as...
You likely can't join if
- Prior treatment with OMTX705 or nab-paclitaxel for the locally advanced (adjuvant or neoadjuvant) for metastatic disease. Previous use of gemcitabine...
- Treatment with systemic anticancer treatments, investigational products, or major surgery within 4 weeks before the first dose of study drug or 5...
- History of uncontrolled brain metastasis. Participants with brain metastases are allowed if they are previously treated with surgery, whole-brain...
- Participant has received extended field radiotherapy ≤4 weeks before the start of treatment (≤1 week for limited field radiation for palliation), and...
- Major surgical procedure or significant traumatic injury ≤21 days prior to ICF signature.
- Cardiac arrhythmias requiring anti-arrhythmic therapy. Note: pacemakers, beta blockers, or digoxin are permitted.
See the full eligibility criteria
Who can join
- Capable of giving signed informed consent.
- Male and female participant aged 18 years and older.
- Participants must have histologically or cytologically confirmed PDAC: a) Metastatic PDAC who have not received therapy or received 1 prior line of systemic cytotoxic therapy (Part 1 and Part 2) and if trial treatment...
- Participants should have documented disease progression if previously locally advanced disease or be in 2nd line for stage IV or, in the opinion of the investigator, despite of lack of documented PD per image, require a...
- Participants should be considered in general eligible for standard GA, for first or second line for metastatic disease (Part 1 and 2) or as palliative therapy for non-resectable locoregional cancer (Part 1 only)...
- Measurable disease by RECIST v1.1 on CT PET/CT or magnetic resonance imaging (MRI) scan.
- Eastern Cooperative Group Performance (ECOG) performance status 0-1.
- Adequate bone marrow, hepatic and renal function: a) Total bilirubin ≤1.5 times upper limit of normal (ULN) or total bilirubin n \<3.0 × ULN with direct bilirubin within normal range in participants with documented...
- Women of childbearing potential (WOCBP) and men with sexual partners who are WOCBP must be willing to adhere to highly effective contraceptive requirements and must agree to avoid impregnating a partner or becoming...
- Suitable venous access for safe drug administration and the study-required drug concentration and pharmacodynamics sampling.
- A valid archival tumor sample.
- Pretreatment fresh biopsy is optional in Part 1 dose escalation. In Part 2, a fresh pretreatment biopsy and on-treatment is required unless biopsy is associated with significant risk and per discussion with the sponsor...
What rules you out
- Prior treatment with OMTX705 or nab-paclitaxel for the locally advanced (adjuvant or neoadjuvant) for metastatic disease. Previous use of gemcitabine as radiosensitizer or as part of neoadjuvant/adjuvant therapy is...
- Treatment with systemic anticancer treatments, investigational products, or major surgery within 4 weeks before the first dose of study drug or 5 half-lives, whichever is shorter. Participants should have recovered from...
- History of uncontrolled brain metastasis. Participants with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and have brain imaging during...
- Participant has received extended field radiotherapy ≤4 weeks before the start of treatment (≤1 week for limited field radiation for palliation), and who has not recovered to Grade 1 or better from related side effects...
- Major surgical procedure or significant traumatic injury ≤21 days prior to ICF signature.
- Cardiac arrhythmias requiring anti-arrhythmic therapy. Note: pacemakers, beta blockers, or digoxin are permitted.
- Active infection requiring parenteral or oral antibiotics. Antibiotics given for prophylaxis are allowed. They are also allowed for minor localized infections like cystitis, amygdalates or localized skin infections.
- Evidence of serious uncontrolled medical disorder that, in the opinion of the investigator or medical monitor, makes it unwise for the participant to participate in the study or that might jeopardize compliance with the...
- Drainage of ascitic or pleural fluid two or more times in the four weeks prior to the first dose of study drug or permanent drain in place (e.g., PleurX®) for ascites or pleural effusion symptom management.
- Placement of a biliary stent, endoscopic retrograde cholangiopancreatography (ERCP) or biliary catheterization (internal or percutaneous) procedure \<7 days before the first dose.
- 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.
- Previous or concurrent cancer that is distinct in primary site or histology from PDAC within 3 years prior to randomization except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial...
- Uncontrolled or significant cardiovascular disease defined by the New York Hearth Association classification III or IV.
- History of cerebrovascular stroke or myocardial infarction within the previous 3 months.
- Grade ≥2 peripheral neuropathy.
- Received a live vaccine within 30 days prior to first dose of study drug.
- Known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. Note: Participants who have positive hepatitis B surface antigen antibody can be included but must have an...
- Participants positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive participants must meet the following criteria: a) have CD4+ T-cell (CD4+) counts ≥350 cells/μL; b) have not...
- Known or suspected allergy to study treatment or related products, and specifically participants with a prior history of life-threatening reaction to polysorbate 20.
- Women who are pregnant or breastfeeding or trying to become pregnant.
- Male participants wishing fathering children, planning for future sperm banking, or expressing concerns about sterility.
- Participants 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, they should be stopped at...
- Except Part1A: History of autoimmune disease requiring systemic immunosuppressive therapy (daily prednisone equivalent doses \>10 mg/day).
- Except Part 1A: Participants who discontinued prior treatment with any immune checkpoint due to irAEs, irrespective of grade, recovery, or need for continued steroid therapy. Also, participants without formal...
- Except Part 1A: participants with a history of pneumonitis/interstitial lung disease, and participants who discontinued prior immune checkpoint inhibitors due to Grade 2 myocarditis.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Barcelona, Spain
- Donostia / San Sebastian, Spain
- L'Hospitalet de Llobregat, Spain
- Madrid, Spain
- Pamplona, Spain
- Santiago de Compostela, 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, Spain; Donostia / San Sebastian, Spain; L'Hospitalet de Llobregat, Spain; Madrid, Spain; Pamplona, Spain and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.