INCB99318 / Incyte - LARVOL DELTA

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of increasing oral doses of INCB099318 in healthy adult participants, and the effect of food on pharmacokinetics. (ANZCTR) - P1 | N=72 | Completed | Sponsor: Incyte Corporation | Not yet recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=105 | Terminated | Sponsor: Incyte Corporation | Trial completion date: Jun 2026 ➔ Aug 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ Aug 2024; A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.

Metastases • Trial completion date • Trial primary completion date • Trial termination • Anal Carcinoma • Basal Cell Carcinoma • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Merkel Cell Carcinoma • Mesothelioma • Microsatellite Instability • Nasopharyngeal Carcinoma • Oncology • Ovarian Cancer • Penile Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Urothelial Cancer

Incyte drops pair of PD-L1 drugs as part of 2nd pipeline clear-out this year (FierceBiotech) - "The latest list of discontinued assets includes both of Incyte’s oral, small-molecule PD-L1 inhibitors that were being assessed in phase 1 trials. One of these, INCB99280, was being evaluated in an early-stage solid tumor trial, and the biotech had already set out plans for a phase 1/1b trial in KRASG12C-mutated solid tumors in combination with Bristol Myers Squibb’s Krazati. The other scrapped PD-L1 inhibitor, dubbed INCB99318, was also in a phase 1 solid tumor trial. Also on the chopping block are a couple of LAG3 drug candidates. One of these is a LAG-3 monoclonal antibody dubbed INCAGN2385 that was being developed with Agenus. The other was a bispecific anti–PD1 and anti–LAG-3 antibody dubbed INCA32459 that was being developed with Merus and had undergone a phase 1 study in select advanced malignancies....Finally, Incyte has removed a TIM-3 monoclonal antibody dubbed INCAGN2390, which was another product of the Merus collaboration."

Discontinued • Oncology • Solid Tumor

A Phase 1 Study Exploring the Safety and Tolerability of the Small Molecule PD-L1 Inhibitor INCB099318 in Select Advanced Solid Tumors (ESMO-IO 2023) - P1 | "Conclusions INCB099318 was generally well tolerated at all doses tested. Preliminary safety and response outcomes support future development of INCB099318 for the treatment of select advanced solid tumors."

Clinical • IO biomarker • Metastases • P1 data • Cervical Cancer • Oncology • Solid Tumor

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=105 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Jun 2026 | Trial primary completion date: Jun 2024 ➔ Jan 2026

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Anal Carcinoma • Basal Cell Carcinoma • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Merkel Cell Carcinoma • Mesothelioma • Microsatellite Instability • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Penile Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Urothelial Cancer

A phase 1 study exploring the safety and tolerability of the small-molecule PD-L1 inhibitor, INCB099318, in patients with select advanced solid tumors (SITC 2022) - P1 | "Unlike with the first-generation oral PD-L1 inhibitor, INCB086550, no dose-limiting immune-mediated peripheral neuropathy has occurred with INCB099318 to date. Approval numbers are: Comité d’éthique Institut Jules Bordet (Belgium), CE3326; Ethics Committee Research UZ/KU Leuven (Belgium), S65537; Ethisch Comite UZA/Antwerpen (Belgium), 2021-0592-Edge 001759; Medical Ethics Committee UZ Brussel – VUB (Belgium) EC-2021-285; UZ Gent Etische Commissie (Belgium), BC-10108 CE3326; National Videnskabsetisk komite (Denmark), 2110272; HUS Hospital District of Helsinki and Uusimaa (Finland), HUS/2452/2021; REK South-East Kulmu A (Norway), 253989; Linkoping Department Medicine EC (Sweden), 2021-02574; NHS Fast Track REC (United Kingdom), 21/FT/0058; WIRB (USA), 20201315; Vanderbilt IRB (USA), 211153; WCG IRB (USA), 20201315, 1300136, 1308493. All patients provided written informed consent."

Clinical • P1 data • Oncology • Solid Tumor

Characterization of HZ-G206: A potent and oral small molecule PD-L1 inhibitor (SITC 2022) - "HZ-G206 shows stronger PD-L1 internalization and degradation potency than clinical stage compounds INCB86550 and INCB99318 in hPD-L1-MC38 cell line and IFN-g stimulated human PBMC with IC90 values of 18.1nM and 105.6nM respectively...In in-vivo anti-tumor evaluation, oral administration of HZ-G206 BID can significantly suppress the growth of tumor in a dose dependent manner, the TGI of middle dose group is comparable to Atezolizumab...The compound is identified with potent in-vitro activity which translates to anti-tumor efficacy in pre-clinical animal study. In conclusion, HZ-G206 is an excellent drug candidate for further clinical development."

Oncology • IFNG

Data From Incyte’s Oncology Portfolio to Be Presented at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting (Businesswire) - "Incyte...will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, held November 8-12, 2022, in Boston and virtually....'We look forward to presenting data at the SITC Annual Meeting from our immuno-oncology pipeline, including our oral PD-L1 program, as we make progress toward our goal of identifying new solutions for patients with cancer who need additional options'."

P1 data • P2 data • Cervical Cancer • Cutaneous Melanoma • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Nasopharyngeal Carcinoma • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Incyte Corporation | Trial completion date: Jun 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Anal Carcinoma • Basal Cell Carcinoma • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Merkel Cell Carcinoma • Mesothelioma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Penile Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Urothelial Cancer

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Incyte Corporation | N=100 ➔ 140 | Trial completion date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: May 2022 ➔ Jun 2023

Enrollment change • Trial completion date • Trial primary completion date • Anal Carcinoma • Basal Cell Carcinoma • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Merkel Cell Carcinoma • Mesothelioma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Penile Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Urothelial Cancer

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Incyte Corporation; Trial completion date: Oct 2023 ➔ Dec 2022

Trial completion date • Anal Carcinoma • Basal Cell Carcinoma • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Merkel Cell Carcinoma • Mesothelioma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Penile Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Urothelial Cancer

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Incyte Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Anal Carcinoma • Basal Cell Carcinoma • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Merkel Cell Carcinoma • Mesothelioma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Penile Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Urothelial Cancer

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=100; Not yet recruiting; Sponsor: Incyte Corporation; Initiation date: Jun 2020 ➔ Feb 2021; Trial primary completion date: Oct 2023 ➔ May 2022

Clinical • Trial initiation date • Trial primary completion date • Anal Carcinoma • Basal Cell Carcinoma • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Merkel Cell Carcinoma • Mesothelioma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Oncology • Ovarian Cancer • Penile Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Urothelial Cancer

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Incyte Corporation; N=140 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Anal Carcinoma • Basal Cell Carcinoma • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Hepatocellular Cancer • Lung Cancer • Merkel Cell Carcinoma • Mesothelioma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=140; Not yet recruiting; Sponsor: Incyte Corporation

Clinical • New P1 trial