NCT04242199 is a Phase 1 clinical trial of INCB099280 in Advanced Solid Tumor, sponsored by Incyte Corporation.

Who is sponsoring NCT04242199?

NCT04242199 is sponsored by Incyte Corporation.

What drugs are being tested in NCT04242199?

Interventions in NCT04242199: INCB099280.

What condition does NCT04242199 study?

NCT04242199 studies Advanced Solid Tumor, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, Cervical Cancer, HepatoCellular Carcinoma, Esophageal Squamous Cell Carcinoma, Merkel Cell Carcinoma, Small-cell Lung Cancer, Mesothelioma, PD-L1 Amplified Tumor (9p24.1), Nasopharyngeal Carcinoma.

Is NCT04242199 still recruiting?

NCT04242199 is currently completed. Last updated 14 July 2025.

Last reviewed 2025-07-14 · How we verify

NCT04242199

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors

Completed Phase 1 Last updated 14 July 2025

What this trial tests

Phase 1 trial testing INCB099280 in Advanced Solid Tumor in 182 participants. Completed in 21 November 2024.

Timeline

4 September 2020

Primary endpoint
29 August 2024

21 November 2024

Quick facts

Lead sponsor	Incyte Corporation
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	182
Start date	4 September 2020
Primary completion	29 August 2024
Estimated completion	21 November 2024
Sites	21 locations across France, Japan, Belgium, Australia, United States

Drugs / interventions tested

INCB099280 — full drug profile →

Conditions studied

Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
MSI-H/dMMR Tumors — all drugs for MSI-H/dMMR Tumors →
Cutaneous Squamous Cell Carcinoma — all drugs for Cutaneous Squamous Cell Carcinoma →
Urothelial Carcinoma — all drugs for Urothelial Carcinoma →

Sponsor

Incyte Corporation — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor or MSI-H/dMMR Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Developing Drugs for Tissue-Agnostic Indications: A Paradigm Shift in Leveraging Cancer Biology for Precision Medicine.
Seligson ND, Knepper TC, Ragg S, Walko CM. · · 2021 · cited 38× · PMID 32535906 · DOI 10.1002/cpt.1946
Merkel Cell Carcinoma from Molecular Pathology to Novel Therapies.
Stachyra K, Dudzisz-Śledź M, Bylina E, Szumera-Ciećkiewicz A, et al · · 2021 · cited 21× · PMID 34208339 · DOI 10.3390/ijms22126305
Merkel Cell Carcinoma: An Immunotherapy Fairy-Tale?
Tanda ET, d'Amato AL, Rossi G, Croce E, et al · · 2021 · cited 20× · PMID 34631574 · DOI 10.3389/fonc.2021.739006
T-Cell Responses in Merkel Cell Carcinoma: Implications for Improved Immune Checkpoint Blockade and Other Therapeutic Options.
Gehrcken L, Sauerer T, Schaft N, Dörrie J. · · 2021 · cited 5× · PMID 34445385 · DOI 10.3390/ijms22168679
Systemic Therapy for Non-Melanoma Skin Cancers: Latest Advances.
Lessans S, O'Connell KA, Choe J. · · 2024 · cited 4× · PMID 38954315 · DOI 10.1007/s11912-024-01570-1
Current Status of Immunotherapy in Management of Small Bowel Neuroendocrine Tumors.
Fields BC, Ayabe RI, Seo YD, Maxwell JE, et al · · 2024 · cited 1× · PMID 39466478 · DOI 10.1007/s11912-024-01610-w
Management of Cutaneous Head and Neck Squamous and Basal Cell Carcinomas for Immunocompromised Patients.
Bommakanti KK, Kosaraju N, Tam K, Chai-Ho W, et al · · 2023 · cited 1× · PMID 37444461 · DOI 10.3390/cancers15133348
Advancements in the utilization of immune checkpoint inhibitors for the treatment of gynecological tumors.
Su Z, Zhang X, Xu J, Shen Y. · · 2026 · PMID 41983132 · DOI 10.3389/fimmu.2026.1686568

Verify or expand the search:

Other trials of INCB099280

Trials testing the same drug.

NCT06309394 — A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 i · Phase 1 · completed
NCT06337162 — Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC) · Phase 1 · withdrawn
NCT05949632 — A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors · Phase 1, PHASE2 · terminated
NCT06039384 — A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation · Phase 1 · terminated
NCT05879822 — A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive · Phase 2 · active not recruiting

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting

Other Incyte Corporation trials

Trials by the same sponsor.

NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms · Phase 1 · recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting
NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04242199 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 14 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04242199.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing