NIS793

DRUG9 trials

Sponsors

Novartis Pharmaceuticals, Colin D. Weekes, M.D., PhD, Kimberly Perez, MD

Conditions

Borderline Resectable Pancreatic AdenocarcinomaBreast CancerColorectal CancerHepatocellular CancerLung CancerMetastatic Colorectal CancerMetastatic Pancreatic AdenocarcinomaMetastatic Pancreatic Cancer

Phase 1

Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.

CompletedNCT02947165

Novartis PharmaceuticalsBreast Cancer, Colorectal Cancer, Hepatocellular Cancer +3

Start: 2017-04-25End: 2021-06-18Updated: 2022-01-31

Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

TerminatedNCT04097821

Novartis PharmaceuticalsMyelofibrosis

Start: 2019-09-26End: 2024-08-28Updated: 2025-08-07

Study of Select Combinations in Adults With Myelofibrosis

WithdrawnNCT04283526

Novartis PharmaceuticalsMyelofibrosis, PMF, Post-Essential Thrombocythemia Myelofibrosis +2

Start: 2020-11-30End: 2024-04-11Updated: 2021-03-04

Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS

TerminatedNCT04810611

Novartis PharmaceuticalsMyelodysplastic Syndromes

Start: 2021-06-18End: 2024-04-19Updated: 2025-10-10

FOLFIRINOX + NIS793 in Pancreatic Cancer

TerminatedNCT05417386

Colin D. Weekes, M.D., PhDMetastatic Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer, Pancreas Cancer

Start: 2022-08-09End: 2023-07-10Updated: 2025-11-18

Phase 2

Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

TerminatedNCT04390763

Novartis PharmaceuticalsMetastatic Pancreatic Ductal Adenocarcinoma

Start: 2020-10-16End: 2024-05-02Updated: 2025-10-16

Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC

TerminatedNCT04952753

Novartis PharmaceuticalsMetastatic Colorectal Cancer

Start: 2021-11-15End: 2025-01-20Updated: 2025-03-26

A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer

TerminatedNCT05546411

Kimberly Perez, MDBorderline Resectable Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma, Pancreatic Cancer +1

Start: 2023-01-06End: 2023-10-13Updated: 2024-12-17

Phase 3

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

CompletedNCT04935359

Novartis PharmaceuticalsMetastatic Pancreatic Ductal Adenocarcinoma

Start: 2021-09-30End: 2024-08-13Updated: 2025-01-07

Related Papers

ADORE: an open platform study of ruxolitinib in combination with other novel therapies in patients with myelofibrosis

Blood Advances2025-05-07

First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors

Frontiers in Oncology2024-10-298 citations

New advances in cancer therapy targeting TGF-β signaling pathways

Molecular Therapy — Oncolytics2023-12-0127 citations

Effects of IL-1β inhibition on anemia and clonal hematopoiesis in the randomized CANTOS trial

Blood Advances2023-11-0736 citations

Phase I/Ib, open-label, multicenter, dose-escalation study of the anti-TGF-β monoclonal antibody, NIS793, in combination with spartalizumab in adult patients with advanced tumors

Journal for ImmunoTherapy of Cancer2023-11-0132 citations

798 TGFβ blockade in pancreatic cancer enhances sensitivity to combination chemotherapy

Regular and Young Investigator Award Abstracts2023-10-312 citations

Patient-reported outcomes (PROs) and biomarkers in daNIS-2, a phase III study comparing NIS793 plus nab-paclitaxel/gemcitabine (NG) vs placebo plus NG in first-line (1L) metastatic pancreatic ductal adenocarcinoma (mPDAC).

Journal of Clinical Oncology2023-01-241 citations

Phase Ib study testing neoadjuvant transforming growth factor (TGF)-β antibody, NIS793, plus 5-fluorouracil, irinotecan, and oxaliplatin chemotherapy (FOLFIRINOX) in patients (pts) with borderline resectable (BR)/locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC).

Journal of Clinical Oncology2023-01-241 citations

Phase II study (daNIS-1) of the anti–TGF-β monoclonal antibody (mAb) NIS793 with and without the PD-1 inhibitor spartalizumab in combination with nab-paclitaxel/gemcitabine (NG) versus NG alone in patients (pts) with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

Journal of Clinical Oncology2023-01-24

Patient-reported outcomes (PROs) and biomarker assessments in daNIS-3, a phase II platform study of NIS793 (anti–TGF-β monoclonal antibody) and other investigational drug combinations with standard of care (SOC) vs SOC alone in patients (pts) with second-line metastatic colorectal cancer (mCRC).

Journal of Clinical Oncology2023-01-24

Siremadlin, a Human Double Minute-2 (HDM2) Inhibitor, Added to Ruxolitinib after Suboptimal Response to Ruxolitinib Alone in Patients with Myelofibrosis: Results from Part 1 of the Phase 1/2 Adore Study

Blood2022-11-154 citations

Phase III study (daNIS-2) of the anti–TGF-β monoclonal antibody (mAb) NIS793 with nab-paclitaxel/gemcitabine (NG) versus NG alone in patients (pts) with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

Journal of Clinical Oncology2022-06-016 citations

Phase II study (daNIS-1) of the anti-TGF-β monoclonal antibody (mAb) NIS793 with and without the PD-1 inhibitor spartalizumab in combination with nab-paclitaxel/gemcitabine (NG) versus NG alone in patients (pts) with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

Journal of Clinical Oncology2022-06-01

Phase Ib study of the anti-TGF-β monoclonal antibody (mAb) NIS793 combined with spartalizumab (PDR001), a PD-1 inhibitor, in patients (pts) with advanced solid tumors.

Journal of Clinical Oncology2021-05-2037 citations

Phase II study of the anti-TGF-β monoclonal antibody (mAb) NIS793 with and without the PD-1 inhibitor spartalizumab in combination with nab-paclitaxel/gemcitabine (NG) versus NG alone in patients (pts) with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

Journal of Clinical Oncology2021-05-208 citations

Adore: A Randomized, Open-Label, Phase 1/2 Open-Platform Study Evaluating Safety and Efficacy of Novel Ruxolitinib Combinations in Patients with Myelofibrosis

Blood2020-11-0510 citations

α-PD-1 therapy elevates Treg/Th balance and increases tumor cell pSmad3 that are both targeted by α-TGFβ antibody to promote durable rejection and immunity in squamous cell carcinomas

Journal for ImmunoTherapy of Cancer2019-03-04166 citations