NCT04989387

Study of INCA 0186 in Subjects With Advanced Solid Tumors

Terminated Phase 1 Last updated 2 September 2025

What this trial tests

Phase 1 trial testing INCA00186 in Advanced Solid Tumors in 57 participants. Terminated before completion.

Timeline

4 October 2021

Primary endpoint
19 September 2024

19 September 2024

Quick facts

Lead sponsor	Incyte Corporation
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	4 October 2021
Primary completion	19 September 2024
Estimated completion	19 September 2024
Sites	32 locations across Netherlands, Belgium, Austria, United Kingdom, United States, Spain

Drugs / interventions tested

• INCA00186 — full drug profile →
• Retifanlimab (RETIFANLIMAB) — full drug profile →
• INCB106385 — full drug profile →

Conditions studied

• Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
• Squamous Cell Carcinoma of the Head and Neck (SCCHN) — all drugs for Squamous Cell Carcinoma of the Head and Neck (SCCHN) →
• Gastrointestinal (GI) Malignancies — all drugs for Gastrointestinal (GI) Malignancies →

Sponsor

Incyte Corporation — full company profile →

Who can join

Adults 18 to 90, any sex, with Advanced Solid Tumors or Squamous Cell Carcinoma of the Head and Neck (SCCHN). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.

Publications & conference data

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

1. Nucleotide metabolism: a pan-cancer metabolic dependency.
   Mullen NJ, Singh PK. · · 2023 · cited 308× · PMID 36973407 · DOI 10.1038/s41568-023-00557-7
2. CD39/CD73/A2AR pathway and cancer immunotherapy.
   Xia C, Yin S, To KKW, Fu L. · · 2023 · cited 230× · PMID 36859386 · DOI 10.1186/s12943-023-01733-x
3. ATP and Adenosine Metabolism in Cancer: Exploitation for Therapeutic Gain.
   Yegutkin GG, Boison D. · · 2022 · cited 111× · PMID 35738682 · DOI 10.1124/pharmrev.121.000528
4. Next steps for clinical translation of adenosine pathway inhibition in cancer immunotherapy.
   Augustin RC, Leone RD, Naing A, Fong L, et al · · 2022 · cited 103× · PMID 35135866 · DOI 10.1136/jitc-2021-004089
5. Targeting purinergic pathway to enhance radiotherapy-induced immunogenic cancer cell death.
   Bao X, Xie L. · · 2022 · cited 54× · PMID 35836249 · DOI 10.1186/s13046-022-02430-1
6. The ectonucleotidases CD39 and CD73 on T cells: The new pillar of hematological malignancy.
   Jiang X, Wu X, Xiao Y, Wang P, et al · · 2023 · cited 33× · PMID 36776866 · DOI 10.3389/fimmu.2023.1110325
7. Inhibitors of the CD73-adenosinergic checkpoint as promising combinatory agents for conventional and advanced cancer immunotherapy.
   Kurago Z, Guo G, Shi H, Bollag RJ, et al · · 2023 · cited 30× · PMID 37435071 · DOI 10.3389/fimmu.2023.1212209
8. The inhibitory effect of adenosine on tumor adaptive immunity and intervention strategies.
   Wang L, Zhang J, Zhang W, Zheng M, et al · · 2024 · cited 28× · PMID 38799637 · DOI 10.1016/j.apsb.2023.12.004