Certepetide Phase 1b/2a Continuous Infusion Trial in mPDAC

Inclusion Criteria: * Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been treated previously and be eligible for treatment with nab-paclitaxel and gemcitabine * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy ≥ 3 months * At least one measurable tumor lesion as assessed by RECIST 1.1 * Adequate organ and marrow function * Adequate contraception Exclusion Criteria: * Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy, or biological agents * Received prior anti-cancer therapy for their pancreatic cancer * Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of subject safety or study results, including but not limited to: * Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment * Active infection (viral, fungal, or bacterial) requiring systemic therapy * Known active hepatitis B virus, hepatitis C virus, or HIV infection * Active tuberculosis as defined per local guidance * History of allogeneic tissue/solid organ transplant * Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast * Pregnant or breastfeeding * Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization * History or clinical evidence of symptomatic central nervous system (CNS) metastases * Enrolled in any other clinical protocol or investigational trial