← Back to Search

Other

IPN01194 for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Ipsen
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 at end of treatment (up to approximately 32 months)
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to find out the right amount of the drug IPN01194 for adults with advanced solid tumors. Participants in the study will have cancers that have spread to nearby tissues or other parts of

Who is the study for?
Adults over 18 with advanced solid tumors like melanoma, colorectal cancer, pancreatic cancer, or head and neck squamous cell carcinoma can join. They must have specific genetic mutations (MAPKm), measurable disease by RECIST criteria, and be in good physical condition (ECOG/PS of 0 or 1). No other effective standard treatments should be available for them.
What is being tested?
The trial is testing IPN01194's correct dosage, safety, and effectiveness when taken orally by adults with advanced solid tumors. All participants will receive the study drug to see how well it works against their cancers.
What are the potential side effects?
While the exact side effects are not listed here, common ones for cancer drugs include nausea, fatigue, diarrhea, risk of infection due to lowered immunity; skin changes; and possible allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at end of treatment (up to approximately 32 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of treatment (up to approximately 32 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs)
Phase 2a: Objective response rate (ORR)
Secondary study objectives
Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194
Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state
Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state
+5 more

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: Phase IIa (Cohort Expansion)Experimental Treatment1 Intervention
Study intervention will be administered at one of two doses of interest determined at the end of Phase I.
Group II: Phase I (Dose Escalation with Backfilling)Experimental Treatment1 Intervention
Nine dose levels are planned to be tested.

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor
350 Previous Clinical Trials
74,105 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
260 Previous Clinical Trials
56,023 Total Patients Enrolled
~147 spots leftby Mar 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top