NCT04574583View on ClinicalTrials.gov

"Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta Trap/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)"

PHASE1/PHASE2CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

November 24, 2020

Primary Completion Date

February 7, 2023

Study Completion Date

May 19, 2023

Conditions

Metastatic CancerSolid Tumors

Interventions

DRUG

SX-682

SX-682 will be given orally at designated dose twice a day every day

DRUG

M7824

Subjects will receive M7824 at a flat dose of 1,200 mg intravenously on Days 1 and 15 of each cycle.

BIOLOGICAL

MVA-BN-CV301

MVA-BN-CV301 will be given as four subcutaneous injections (4x10\^8 Inf.U/0.5ml twice during Cycle 1 (Days 1 and 15)

BIOLOGICAL

recombinant fowlpox viral (FPV)-CV301

FPV-CV301 will be given as one subcutaneous injection (1x10\^9 Inf.U/0.5ml) on Day 1 starting at cycle 2 through cycle 5 (every 4 weeks) then on Day 1 of every 3 cycles (Cycles 8 and Cycle 11).

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors

lead

National Cancer Institute (NCI)

NIH

NCT04574583 - "Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta Trap/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)" | Biotech Hunter | Biotech Hunter