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GNS561 for Intrahepatic Cholangiocarcinoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Genoscience Pharma
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 dose-limiting toxicity will be evaluated during the 4 - week dose escalation phase.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called GNS561 in patients with advanced liver cancer. The goal is to see if the drug is safe, what side effects it might have, and how it behaves in the body. Patients will take the drug regularly after meals.

Eligible Conditions
  • Liver Cancer
  • Intrahepatic Cholangiocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dose-limiting toxicity will be evaluated during the 4 - week dose escalation phase.
This trial's timeline: 3 weeks for screening, Varies for treatment, and dose-limiting toxicity will be evaluated during the 4 - week dose escalation phase. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-Limiting Toxicity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment1 Intervention
Dose escalation using 3+3 design with dose limiting toxicity (DLT) observation period of 28 days.
Group II: Dose ExpansionExperimental Treatment1 Intervention
Additional patients will be enrolled into the recommended dose. These additional patients will undergo all of the same assessments as the patients enrolled in dose escalation with the exception of PK sampling.

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Who is running the clinical trial?

Genoscience PharmaLead Sponsor
3 Previous Clinical Trials
208 Total Patients Enrolled
~7 spots leftby Nov 2025
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