Study of INCA 0186 in Subjects With Advanced Solid Tumors
Colon/Rectal Cancer
Liver Cancer / Hepatoblastoma
Stomach/ Gastric Cancer
18 - 90 Years, Male and Female
INCA 0186-101 (primary)
NCI-2022-01925
Summary
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.
Eligibility
- 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
Treatment Sites in Georgia
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