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NCT03522142
A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies
Phase 1 trial testing INCB081776 in Advanced Solid Tumors in 83 participants. Terminated before completion.
10 September 2025
Quick facts
| Lead sponsor | Incyte Corporation |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 83 |
| Start date | 27 August 2018 |
| Primary completion | 10 September 2025 |
| Estimated completion | 10 September 2025 |
| Sites | 18 locations across Norway, Sweden, Netherlands, United States, Denmark |
Drugs / interventions tested
- INCB081776 — full drug profile →
- INCMGA00012 — 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, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and INCB081776 in combination with INCMGA00012 (Part 2).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting Tyro3, Axl and MerTK (TAM receptors): implications for macrophages in the tumor microenvironment.
Myers KV, Amend SR, Pienta KJ. · · 2019 · cited 333× · PMID 31088471 · DOI 10.1186/s12943-019-1022-2 -
Tumor Plasticity and Resistance to Immunotherapy.
Horn LA, Fousek K, Palena C. · · 2020 · cited 113× · PMID 32348738 · DOI 10.1016/j.trecan.2020.02.001 -
The Role of the Receptor Tyrosine Kinase Axl in Carcinogenesis and Development of Therapeutic Resistance: An Overview of Molecular Mechanisms and Future Applications.
Wium M, Ajayi-Smith AF, Paccez JD, Zerbini LF. · · 2021 · cited 56× · PMID 33806258 · DOI 10.3390/cancers13071521 -
Epithelial-Mesenchymal Plasticity in Tumor Immune Evasion.
Mullins RDZ, Pal A, Barrett TF, Heft Neal ME, et al · · 2022 · cited 53× · PMID 35363853 · DOI 10.1158/0008-5472.can-21-4370 -
AXL as a Target in Breast Cancer Therapy.
Colavito SA. · · 2020 · cited 50× · PMID 32148495 · DOI 10.1155/2020/5291952 -
AXL Inhibitors: Status of Clinical Development.
Bhalla S, Gerber DE. · · 2023 · cited 46× · PMID 36920638 · DOI 10.1007/s11912-023-01392-7 -
The Development of AXL Inhibitors in Lung Cancer: Recent Progress and Challenges.
Sang YB, Kim JH, Kim CG, Hong MH, et al · · 2022 · cited 45× · PMID 35311091 · DOI 10.3389/fonc.2022.811247 -
Addressing CPI resistance in NSCLC: targeting TAM receptors to modulate the tumor microenvironment and future prospects.
Peters S, Paz-Ares L, Herbst RS, Reck M. · · 2022 · cited 43× · PMID 35858709 · DOI 10.1136/jitc-2022-004863
Verify or expand the search:
- PubMed search for NCT03522142
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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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)
- Trial protocol + status: ClinicalTrials.gov NCT03522142 (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: 9 October 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/NCT03522142.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing