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Brief Title: Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101
Official Title: An Open-Label, Multicenter Phase 1/1b Study of Intratumorally Administered STING Agonist E7766 in Subjects With Advanced Solid Tumors or Lymphomas - INSTAL-101
Study ID: NCT04144140
Brief Summary: This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intratumorally in participants with advanced solid tumors or lymphomas.
Detailed Description: The Phase 1/1b study consist of two parts: Dose Escalation and Dose Expansion. In the Dose Escalation Part, E7766 will be administered intratumorally in participants with advanced solid tumors or lymphomas to assess safety/tolerability profile of E7766 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7766. In the Dose Expansion Part, E7766 at RP2D will be administered to participants with melanoma, head and neck squamous cell carcinoma (HNSCC), breast cancer, colorectal cancer, and/or other tumors including lymphomas to confirm safety and assess preliminary clinical activity of E7766 as a single agent. Clinical activity will be evaluated by objective response rate (ORR), duration of response (DOR), and disease control rate (DCR) on treatment with E7766.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Yale New Haven Hospital, New Haven, Connecticut, United States
University of Miami Hospital Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Pittsburgh Medical Center and Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Institut Gustave Roussy, Villejuif, , France
Samsung Medical Center, Seoul, , Korea, Republic of
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
START Madrid, Madrid, , Spain
INCLIVA Hospital Clínico Universitario de Valencia, Valencia, , Spain
Imperial College Healthcare NHS Trust, London, , United Kingdom