INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors (NCT04580485) | Clinical Trial Compass
CompletedPhase 1
INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors
United States54 participantsStarted 2021-02-03
Plain-language summary
This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Ability to comprehend and willingness to sign an ICF.
* Willing and able to conform to and comply with all Protocol requirements.
* Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) that progressed after treatment with available therapies (including anti PD-(L)1 therapy (if applicable).
* Willingness to undergo pre- and on-treatment tumor biopsy.
* Have CD8 T-cell-positive tumors.
* Presence of measurable disease according to RECIST v1.1.
* ECOG performance status 0 to 1.
* Life expectancy \> 12 weeks.
* Willingness to avoid pregnancy or fathering children based.
* Acceptable laboratory parameters
Exclusion Criteria:
* Clinically significant cardiac disease.
* Known or active CNS metastases and/or carcinomatous meningitis.
* Active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease..
* 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.
* Has no…
What they're measuring
1
Number of treatment-emergent adverse events (TEAE)