A Phase 1/2 Study of Indoximod in Combination with Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Adenocarcinoma of the Pancreas
Overview
This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Patient has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell or neuroendocrine neoplasms are excluded.
- Initial diagnosis of metastatic disease must have occurred ≤8 weeks prior to entry in the study.
- Patient has one or more metastatic tumors measurable per RECIST 1.1 by CT scan ≤4 weeks prior to entry into the study
- Male or non-pregnant and non-lactating female, and ≥18 years of age.
- Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
- Prior treatment with gemcitabine and/or nab-paclitaxel in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- Patients cannot have received any other immunomodulatory therapies (including vaccines) as treatment for this or any other cancer.
- Patient has a Karnofsky performance status (KPS) ≥ 70.
- Patients should be asymptomatic for jaundice prior to Day 1.
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Patients may not be receiving (or received prior to enrollment) any other investigational agents for metastatic disease.
- Patient has known brain metastases,
- Patient has only locally advanced disease.
- Lymph node only metastases even if considered M1 disease by official staging criteria.
- History of malignancy in the last 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 3 years.
- Patients with any active autoimmune disease
- Patient has undergone major surgery, other than diagnostic surgery (ie, surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
Phase I/II
Principal Investigator(s)
Vikas Dembla, MD
Sponsor(s)
NewLink Genetics Corporation