Study of INCA 0186 in Subjects With Advanced Solid Tumors

  • End date
    Aug 28, 2024
  • participants needed
  • sponsor
    Incyte Corporation
Updated on 7 October 2022


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.

Condition Advanced Solid Tumors, Squamous Cell Carcinoma of the Head and Neck (SCCHN), Gastrointestinal (GI) Malignancies
Treatment Retifanlimab, INCB106385, INCA00186
Clinical Study IdentifierNCT04989387
SponsorIncyte Corporation
Last Modified on7 October 2022


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Inclusion Criteria

Ability to comprehend and willingness to sign a written ICF for the study
Male or female participant aged 18 years or older inclusive at the time of signing the ICF
Must be willing and able to conform to and comply with all Protocol requirements
Willingness to undergo pre- and on-treatment tumor biopsy
Have CD8 T-cell-positive tumors
ECOG performance status 0 or 1
Measurable disease according to RECIST v1.1
Participants with SCCHN: Participants with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx not amenable to local therapy with curative intent (surgery or radiation with or without chemotherapy)
Participants with specified GI malignancies: Histologically or cytologically confirmed advanced or metastatic colorectal (CRC), gastric/gastroesophageal junction (GEJ) cancer, hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), or squamous carcinoma of the anal canal (SCAC)
Participants should have disease progression after treatment with available therapies, including anti-PD-(L)1 therapy (if applicable), that are known to confer clinical benefit or who are intolerant to or ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance
For participants to be enrolled in cohorts including INCB106385: The ability to swallow oral medication
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Clinically significant cardiac disease, unstable angina, acute myocardial infarction within 6 months of Cycle 1 Day 1, and New York Heart Association Class III or IV congestive heart failure
History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful
Known active CNS metastases and/or carcinomatous meningitis
Participants who have active or inactive autoimmune disease or syndrome (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses > 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment
Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study treatment with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease free > 1 year after treatment with curative intent
Participants with protocol specified exclusionary hematology, hepatic, renal and coagulation laboratory values at screening
Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior
immunotherapy) and/or complications from prior surgical intervention before starting study
Evidence of interstitial lung disease, history of interstitial lung disease, or active
noninfectious pneumonitis
Immune-related toxicity during prior immune therapy for which permanent
discontinuation of therapy is recommended, OR any immune-related toxicity requiring
intensive or prolonged immunosuppression to manage
Prior treatment with any adenosine pathway targeting drugs
Any prior chemotherapy, biological therapy, or targeted therapy to treat the
participant's disease within 5 half-lives or 28 days (whichever is shorter) before the
first dose of study treatment
Any prior radiation therapy within 28 days before the first dose of study treatment
Undergoing treatment with another investigational medication or having been treated
with an investigational medication within 5 half-lives or 28 days (whichever is
shorter) before the first dose of study treatment
For participants to be enrolled in cohorts including INCB106385: concomitant treatment
with strong CYP3A4 inhibitors or inducers
Receipt of a live virus vaccine within 30 days of the first dose of study treatment
Infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week
of the first dose of study treatment
Known or suspected SARS-CoV-2 infection at the time of enrollment
Active HBV or HCV infection that requires treatment. HBV-DNA and HCV-RNA must be
undetectable. Participants who have cleared a prior HBV infection (defined as HBsAg
negative, HBsAg antibody positive, and anti-HBc antibody positive) are eligible for
the study
Known history of HIV (HIV 1/2 antibodies)
History of organ transplant, including allogeneic stem-cell transplantation or CAR-T
cell therapy
Known hypersensitivity or severe reaction to any component of study drug(s) or
formulation components
For participants to be enrolled in cohorts including INCB106385: Inability to swallow
food or any concomitant condition of the upper GI tract that precludes administration
of oral medications
Is pregnant or breastfeeding
Any condition that would, in the investigator's judgment, interfere with full
participation in the study, including administration of study treatment and attending
required study visits; pose a significant risk to the participant; or interfere with
interpretation of study data
The following participants are excluded in France: vulnerable populations according to
article L.1121-6 of the French Public Health Code and adults under legal protection or
who are unable to express their consent per article L.1121-8 of the French Public
Health Code
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