Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

Trial number:
Trial phase:
Study type:
Targeted therapy, Chemotherapy
Overall status:

Study start date

September, 2021

Scientific title

A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2


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.

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 surgeryPresence 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.


Applicable for both Safety run-in and Randomized part

Previous systemic anti-cancer treatment for metastatic PDACPancreatic neuroendocrine (islet) or acinar 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)

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Quadruple, Subject masked: Yes, Caregiver masked: Yes, Investigator masked: Yes, Outcomes assessor masked: Yes,


Metastatic Pancreatic Ductal Adenocarcinoma

Other study ID numbers

CNIS793B12301; 2021-000591-10

Choose trial site (138)

National Cancer Centre Singapore
11 Hospital Crescent, Singapore 169610