NCT06039384 is a Phase 1 clinical trial of INCB099280 in Advanced Solid Tumors, sponsored by Incyte Corporation.

Who is sponsoring NCT06039384?

NCT06039384 is sponsored by Incyte Corporation.

What drugs are being tested in NCT06039384?

Interventions in NCT06039384: INCB099280, adagrasib.

What condition does NCT06039384 study?

NCT06039384 studies Advanced Solid Tumors.

Is NCT06039384 still recruiting?

NCT06039384 is currently terminated. Last updated 3 August 2025.

Last reviewed 2025-08-03 · How we verify

NCT06039384

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

A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

Terminated Phase 1 Last updated 3 August 2025

What this trial tests

Phase 1 trial testing INCB099280 in Advanced Solid Tumors in 6 participants. Terminated before completion.

Timeline

28 December 2023

Primary endpoint
11 April 2025

11 July 2025

Quick facts

Lead sponsor	Incyte Corporation
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	28 December 2023
Primary completion	11 April 2025
Estimated completion	11 July 2025
Sites	14 locations across Italy, United Kingdom, United States, Spain

Drugs / interventions tested

INCB099280 — full drug profile →
adagrasib (ADAGRASIB) — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

Incyte Corporation — full company profile →

Who can join

18 and older, any sex, with Advanced Solid 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 of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib.

Publications & conference data

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

MYC and KRAS cooperation: from historical challenges to therapeutic opportunities in cancer.
Casacuberta-Serra S, González-Larreategui Í, Capitán-Leo D, Soucek L. · · 2024 · cited 43× · PMID 39164274 · DOI 10.1038/s41392-024-01907-z
Targeting KRAS mutations in pancreatic cancer: opportunities for future strategies.
Linehan A, O'Reilly M, McDermott R, O'Kane GM. · · 2024 · cited 24× · PMID 38576709 · DOI 10.3389/fmed.2024.1369136
Targeting the KRAS Oncogene for Patients with Metastatic Colorectal Cancer.
Miao R, Yu J, Kim RD. · · 2025 · cited 8× · PMID 40361439 · DOI 10.3390/cancers17091512
<i>KRAS</i>, a New Target for Precision Medicine in Colorectal Cancer?
Boilève A, Smolenschi C, Lambert A, Boige V, et al · · 2024 · cited 5× · PMID 39456549 · DOI 10.3390/cancers16203455
KRAS mutated NSCLC: past, present, and future directions in a rapidly evolving landscape.
Frisch A, Martin E, Kim SY, Riess JW, et al · · 2025 · cited 4× · PMID 40586765 · DOI 10.1093/oncolo/oyaf153
Drugging the 'undruggable' KRAS: breakthroughs, challenges, and opportunities in pancreatic cancer.
Khan N, Raza U, Ali Zaidi SA, Nuer M, et al · · 2025 · cited 3× · PMID 40624835 · DOI 10.20892/j.issn.2095-3941.2025.0122
Targeted therapy for KRAS G12C-mutated colorectal cancer: advances, challenges, and future directions.
Lin Y, Cheng SH, Wang D, Zhang SH, et al · · 2025 · PMID 41523245 · DOI 10.62347/zzuw3272

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
NCT05879822 — A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive · Phase 2 · active not recruiting
NCT05888844 — A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma · Phase 2 · active not recruiting

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · 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 NCT06039384 (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: 3 August 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/NCT06039384.

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