A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease.

Exclusion Criteria

• •1. Active or uncontrolled infectious disease or serious medical condition that may interfere with the patient's eligibility or treatment.
• •2. History of psychiatric condition that would compromise the patient's ability to understand or comply with the requirements of the protocol, or the ability to provide informed consent.
• •3. Concurrent antineoplastic therapy.
• •4. Prior chemotherapy or chemo-radiation therapy for advanced pancreatic cancer.
• •5. Prior anti-PD-(L)1 or anti-CTLA-4 as prior therapy(ies).
• •6. Pregnant or lactating women.
• •7. History of allergic reactions attributed to compounds of similar chemical structure or similar biological study drug composition.
• •8. History of life-threatening serious adverse events to Gemcitabine or Nab-Paclitaxel.
• •9. Patients requiring or being treated with potent CYP3A4 inhibitors and inducers.
• •10. Other active malignancies undergoing or requiring systemic treatment.
• •11. History of interstitial lung disease.
• •12. Subjects with history or presence of a known clotting disorder or difficulty achieving haemostasis will be excluded.
• •13. Primary or secondary immunodeficiency, including immunosuppressive disease or autoimmune disease (including autoimmune endocrinopathies).
• •Note: Subjects with type 1 diabetes, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible. Subjects with Type 2 diabetes mellitus are allowed.
• •14. Subjects with a known history of human immunodeficiency virus 1 and 2, human T lymphotropic virus 1.
• •15. Prior treatment with anticancer therapies, immunosuppressive agents, corticosteroids, radiation, investigational drugs or vaccines within the following time intervals before the first dose of study treatment (C1D1):
• •(i) Cytotoxic chemotherapy: within 3 weeks prior to C1D1. (ii) Monoclonal antibodies, antibody-drug conjugates or radioimmunoconjugates: within 4 weeks or 5 half-lives, whichever is shorter.
• •(iii) Small-molecule targeted therapies, including tyrosine kinase inhibitors: within 2 weeks or 5 half-lives, whichever is shorter.
• •(iv) Any other anti-neoplastic therapy (including experimental agents): within 3 weeks, except:
• •* Investigational drugs or devices must not have been administered within 21 days or 5 half-lives (whichever is longer).
• •* For investigational agents with long half-lives (\>5 days), earlier enrolment requires approval by the medical monitor.
• •(v) Radiotherapy: - A 1-week washout is permitted for palliative radiation to non-CNS lesions, with medical monitor approval.
• •* Patients must not have experienced radiation pneumonitis or be receiving chronic corticosteroids for this condition.
• •(vi) Corticosteroids: - No systemic corticosteroids within 7 days, except:
• •* inhaled or topical corticosteroids,
• •* corticosteroid premedication for contrast allergy,
• •* physiologic replacement doses, with medical monitor approval. (vii) Immunosuppressive therapies: - No immunosuppressive treatment within 7 days, except for the permitted corticosteroid uses listed above.
• •(viii) SARS-CoV-2 vaccination:
• •* No COVID-19 vaccine within 7 days before randomization.
• •* When feasible, multi-dose vaccine series should be completed prior to randomization.
• •16. Has not recovered to grade ≤1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy.
• •Note: Subjects with grade ≤2 neuropathy and alopecia are an exception and may enroll.
• •17. History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
• •18. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of study enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.
• •a. QTcF (QT interval corrected using Fridericia's formula) of \> 480 ms.
• •19. Concurrent participation in other investigational drug trials.
• •20. Known central nervous system (CNS) involvement as follows:
• •* Untreated CNS metastases.