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Spots Global Cancer Trial Database for Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101

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Trial Identification

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

Interventions

E7766

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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