Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

This study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Applicable for both Safety run-in and Randomized part

• Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery

• Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

• Adequate organ function (assessed by central laboratory for eligibility)

• Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade ≤ 1 (CTCAE v 5.0) at time of screening, except alopecia.

Main Exclusion Criteria:

• Applicable for both Safety run-in and Randomized part

• Previous systemic anti-cancer treatment for metastatic PDAC

• Pancreatic neuroendocrine, acinar, or islet tumors

• Participants with known status of microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer (if status is not already available, testing is not required at screening).

• Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks prior to start of study treatment.

• Radiation therapy or brain radiotherapy ≤ 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed ≤ 2 weeks prior to start of study treatment).

• Impaired cardiac function or clinically significant cardio-vascular disease

• Use of hematopoietic growth factors or transfusion support ≤ 2 weeks prior to start of study treatment.

• Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.

• Serious non-healing wounds.

• Pregnant or breast-feeding women

• Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated

• Pre-existing peripheral neuropathy > grade 1 (CTCAE v5.0)