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Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT04336098
Phase: Phase I
Principal Investigator: Mehta, Rutika
A Phase 1 Study of SRF617 in Patients with Advanced Solid Tumors
A Phase 1, first-in-human, SRF617 monotherapy and combination therapy, dose escalation, safety, and tumor biopsy expansion study of SRF617, an antibody that inhibits CD39 activity, in patients with advanced solid tumors. Inhibition of CD39 activity may improve the ability to mount an immune response against tumor cells.
Primary Objective: Determine the RP2D of SRF617 as monotherapy and in combination therapy in patients with solid tumors Secondary Objectives: Evaluate the safety and tolerability of SRF617 monotherapy and combination therapy Evaluate the PK of SRF617 as monotherapy and combination therapy Evaluate the pharmacodynamics of SRF617 via target occupancy and its relationship to PK Evaluate the preliminary efficacy of SRF617 administered as monotherapy and in combination therapy Evaluate the effect of SRF617 on intratumoral CD39 enzymatic activity (in patients undergoing pretreatment and on-treatment tumor biopsies)
Chemotherapy (NOS); Immunotherapy
Albumin-Bound Paclitaxel (); Gemzar (gemcitabine); Pembrolizumab (Keytruda); SRF617 (); gemcitabine ()
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