INCB106385 / Incyte - LARVOL DELTA

Study of INCA 0186 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=57 | Terminated | Sponsor: Incyte Corporation | Completed ➔ Terminated; This was a strategic business decision. There were no safety concerns contributing to this decision.

Monotherapy • Trial termination • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

Study of INCA 0186 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=57 | Completed | Sponsor: Incyte Corporation | Active, not recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Sep 2024 | Trial primary completion date: Jun 2025 ➔ Sep 2024

Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of increasing oral doses of INCB106385 in healthy adult participants, and the effect of food on pharmacokinetics, as well as drug interaction with a Proton Pump Inhibitor (PPI) esomeprazole. (ANZCTR) - P1 | N=84 | Completed | Sponsor: Incyte Corporation | Not yet recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=54 | Completed | Sponsor: Incyte Corporation | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Monotherapy • Trial completion • Anal Carcinoma • Bladder Cancer • Breast Cancer • Castration-Resistant Prostate Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CD8

Study of INCA 0186 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=57 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: Jan 2024 ➔ Jun 2025 | Trial primary completion date: Jan 2024 ➔ Jun 2025

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

Study of INCA 0186 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=57 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting | N=210 ➔ 57 | Trial completion date: Feb 2025 ➔ Jan 2024 | Trial primary completion date: Feb 2025 ➔ Jan 2024

Combination therapy • Enrollment change • Enrollment closed • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting | N=230 ➔ 54

Combination therapy • Enrollment change • Enrollment closed • IO biomarker • Metastases • Monotherapy • Anal Carcinoma • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • CD8

Phase 1 Study of INCB106385 Alone or in Combination with Immunotherapy in Advanced Solid Tumors (ESMO-IO 2022) - P1 | "This ongoing, 2-part (dose-escalation/expansion) phase 1 study is investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of INCB106385, an oral, potent, selective dual A2A/A2B receptor antagonist, alone or combined with an anti-PD-1 antibody retifanlimab for advanced solid tumors (NCT04580485). Doses ≥80 mg BID were sufficient for target inhibition in most pts. Further dose escalation is ongoing in parallel with dose expansion."

Combination therapy • P1 data • Oncology • Solid Tumor

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=230 | Recruiting | Sponsor: Incyte Corporation | Trial completion date: Apr 2024 ➔ Dec 2023 | Trial primary completion date: Apr 2024 ➔ Dec 2023

Combination therapy • IO biomarker • Monotherapy • Trial completion date • Trial primary completion date • Anal Carcinoma • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • CD8

Study of INCA 0186 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=210 | Recruiting | Sponsor: Incyte Corporation | Trial completion date: Aug 2024 ➔ Jan 2025 | Trial primary completion date: Aug 2024 ➔ Jan 2025

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=238 | Recruiting | Sponsor: Incyte Corporation | Trial completion date: Dec 2023 ➔ Apr 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Combination therapy • IO biomarker • Monotherapy • Trial completion date • Trial primary completion date • Anal Carcinoma • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • CD8

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=238 | Recruiting | Sponsor: Incyte Corporation | Trial completion date: May 2024 ➔ Dec 2023

Combination therapy • IO biomarker • Monotherapy • Trial completion date • Anal Carcinoma • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • CD8

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=238; Recruiting; Sponsor: Incyte Corporation; Trial completion date: Jul 2023 ➔ May 2024; Trial primary completion date: Jul 2023 ➔ Dec 2023

Combination therapy • IO biomarker • Monotherapy • Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • CD8

Study of INCA 0186 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=230; Recruiting; Sponsor: Incyte Corporation; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD73 • CD8

Study of INCA 0186 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=230; Not yet recruiting; Sponsor: Incyte Corporation

New P1 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD73 • CD8

[VIRTUAL] Discovery and preclinical characterization of INCA00186, a humanized monoclonal antibody antagonist of CD73, as a cancer immunotherapy (AACR 2021) - "In summary, the data presented in this study demonstrates that INCA00186 is a potent CD73 antagonist and effectively attenuates adenosine induced immunosuppression in the tumor microenvironment. INCA00186 demonstrated anti-tumor immunity alone and, to a greater extent, in combination with the A2A/A2B adenosine receptor antagonist INCB106385."

Late-breaking abstract • Preclinical • Breast Cancer • Melanoma • Oncology • Solid Tumor • CD34 • CD73 • ENTPD1 • IFNG

[VIRTUAL] Discovery and characterization of INCB106385: a novel A2A/A2B adenosine receptor antagonist, as a cancer immunotherapy (AACR 2021) - "In summary, the data presented in this study demonstrate that INCB106385 is a potent, selective and orally bioavailable A2A/A2B dual antagonist that can overcome the immune-suppressive effects of high levels of adenosine in the tumor microenvironment. INCB106385 can promote anti-tumor immunity as a monotherapy and in combination with anti-PD-1/PD-L1 treatment."

Late-breaking abstract • Oncology • IFNG

Incyte Announces Data from Multiple Programs Within its Oncology Portfolio Accepted for Presentation at the AACR Annual Meeting 2021 (Businesswire) - "Incyte...announced that multiple abstracts from across its oncology portfolio will be presented during Week 1 of the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021, held virtually from April 10-15, 2021....'At AACR 2021, we look forward to sharing clinical and pre-clinical data from INCB106385, our novel A2A/A2B adenosine receptor antagonist, and INCA00186, our novel CD73 monoclonal antibody—both of which highlight our ongoing efforts targeting the adenosine pathway. Presentations at the congress will also feature updated data from our LIMBER development program, including results from our Phase 2 combination study of ruxolitinib, a janus kinase (JAK1/JAK2) inhibitor, and parsaclisib, a potent, highly selective oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ)'"

Clinical data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Lung Cancer • Myelofibrosis • Non Small Cell Lung Cancer • Oncology

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=230; Recruiting; Sponsor: Incyte Corporation; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • IO biomarker • Monotherapy • Bladder Cancer • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer