New cocktail of drugs takes on tough pancreatic cancer
NCT ID NCT07488884
First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This early-stage trial tests whether adding three new drugs (nogapendekin alfa inbakicept, sotevtamab, and zabadinostat) to standard chemotherapy can safely shrink pancreatic tumors that are hard to remove. About 30 adults with borderline resectable or locally advanced pancreatic cancer will receive the combination before surgery, then continue immunotherapy afterward. The main goal is to check for side effects and see if the treatment helps control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nogapendekin alfa inbakicept, sotevtamab, zabadinostat, gemcitabine, nab-paclitaxel
- What this could lead to
- If successful, this could point toward a more effective treatment approach for pancreatic cancer that is hard to remove with surgery alone.
- What could go wrong
- This is a very early phase 1 trial with only 30 people, focused on safety. The drug combination may cause serious side effects and may not shrink tumors enough to allow surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 4. Histologically or cytologically confirmed PDAC that is confined to the pancreas. 5. Borderline resectable (surgical resection possible but challenging) or locally advanced (surgical resection not possible) PDAC, as determined by the local investigator based onlocal institutional guidelines. 6. Measurable tumor lesions according to RECIST v1.1. (within 90 days prior to first dose of study treatment). 7. Have not received prior anticancer therapy for pancreatic cancer. 8. Ability to attend required study visits and return for adequate follow-up, as required by this protocol. 9. Agreement to practice highly effective contraception for female participants of child-bearing potential and non-sterile males. Female participants of child-bearing potential must agree to use effective contraception for up to 7 months after completion of therapy, and nonsterile male participants must agree to use a condom for up to 7 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and hormonal therapy. Exclusion Criteria: 1. Resectable PDAC, meeting the following criteria upon CT/MRI: (a)No superior mesenteric vein (SMV) or portal vein (PV) distortion; (b) Clear fat planes around superior mesenteric artery (SMA), celiac artery (CA), and common hepatic artery (CHA). 2. Participants for whom an operation is not considered in the participant's best interest (eg, due to comorbidity). 3. Histologically or cytologically confirmed pancreatic tumor that is not adenocarcinoma. 4. CA19-9 \> 1,000 U/mL. 5. QTc interval using Fridericia's formula (QTcF) \> 470 ms. 6. If participants have had major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. 7. Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed. 8. Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 9. Inadequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to baseline: (a) Absolute neutrophil count (ANC) \< 1,500 cells/μL without granulocyte colonystimulating factor support, (b) Lymphocyte count \< 500/μL, (c) platelet count \< 100,000/μL without transfusion (d) Hemoglobin \< 8.0 g/dL Note: Participants may be transfused to meet this criterion, (e) International Normalized Ratio (INR) or aPTT activated partial thromboplastin time (aPTT) \< 1.5 × upper limit of normal (ULN) Note: This applies only to participants who are not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose. (f) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \> 2.5 × ULN, with the following exception: Participants with documented liver metastases: AST and/or ALT \> 5 × ULN. (g) Serum bilirubin ≤ 3 × ULN (h) Creatinine clearance ≤ 60 mL/min (calculated using the Cockcroft-Gault formula), (i) Serum albumin ≤ 3.0 g/dL. (j) Urine dipstick for proteinuria \> 2+ (within 7 days prior to initiation of study treatment). Participants with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate \< 1 g of protein in 24 hours. 10. Significant cardiovascular disease (such as New York Heart Association cardiac disease class II or greater), myocardial infarction within 3 months prior to baseline, unstable arrhythmias, or unstable angina. 11. Severe infections at the time of enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. 12. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Participants receiving prophylactic antibiotics (eg, to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. 13. Prior allogeneic bone marrow transplantation or solid organ transplant. 14. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications. 15. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 16. Treatment with systemic immunosuppressive medications (including, but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to initiation of study treatment, or anticipation of the need for systemic immunosuppressive medication during study treatment, with the following exceptions: (a) A. Participants who have received acute, low-dose, systemic immunosuppressant medications (eg, a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the Medical Monitor, (b)B. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (eg, fludrocortisone) for participants with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed. 17. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study. 18. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 19. Pregnant and nursing women.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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