Eisai Clinical Trials

An Open-Label, Multicenter Phase 1/1b Study of Intratumorally Administered STING Agonist E7766 in Subjects With Advanced Solid Tumors or Lymphomas – INSTAL-101

E7766-G000-101

Study Overview

E7766
E7766
NCT04144140, 2019-000160-17
Feb 2020 - Jul 2022
Advanced Solid Tumors or Lymphomas
1. Dose Escalation Part: Number of Participants With Dose-limiting Toxicities (DLTs) [Time Frame: Cycle 1 (Cycle length= 21 days)]

2. Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) [Time Frame: From the first dose of the study drug up to 90 days after the last dose (up to 9 months and 14 days)]

3. Dose Expansion Part: Objective Response Rate Based on Modified Response Evaluation Criteria In Solid Tumors (mRECIST) v1.1 [Time Frame: From date of first dose of study drug until confirmed CR or PR (up to 29 months)]

  • Males and females 18 Years and older (Adult, Older Adult)

  • Completed

  • Phase 1

  • France, Korea, Republic of, Spain, United Kingdom, United States See more

Results

CSR Synopsis

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Lay Summary

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Data Sharing

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CSDR Sharing is not available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR