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STING Agonist
Dose Expansion: CIS With/Without Ta or T1 for Bladder Cancer
Phase 1
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 weeks of the induction cycle (cycle length is equal to [=] 6 weeks)
Awards & highlights
No Placebo-Only Group
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 intravesically in participants with NMIBC. Both intermediate risk and BCG-unresponsive NMIBC participants will be included.
Eligible Conditions
- Bladder Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 6 weeks of the induction cycle (cycle length is equal to [=] 6 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6 weeks of the induction cycle (cycle length is equal to [=] 6 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Dose Expansion: High-grade Ta or T1, Without CISExperimental Treatment1 Intervention
Group II: Dose Expansion: CIS With/Without Ta or T1Experimental Treatment1 Intervention
Group III: Dose Escalation: NMIBC And BCG Unresponsive NMIBCExperimental Treatment1 Intervention
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Who is running the clinical trial?
Eisai Inc.Lead Sponsor
521 Previous Clinical Trials
159,798 Total Patients Enrolled
H3 Biomedicine Inc.Industry Sponsor
6 Previous Clinical Trials
533 Total Patients Enrolled
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