IPN01194 for Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Ipsen

Must not be taking: QT prolongers, CYP3A4 modulators

Disqualifiers: Infections, Cardiac issues, Brain metastases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours. The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body. In this study, all participants will receive the study drug, which will be taken by mouth (orally).

Will I have to stop taking my current medications?

The trial requires stopping certain medications, such as those that prolong the QT/QTc interval and strong or moderate CYP3A4 inducers or inhibitors. If you are taking these, you may need to stop them before joining the trial.

Eligibility Criteria

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.

Inclusion Criteria

Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1

I am using birth control as required by local laws for clinical trial participants.

I am fully active or can carry out light work.

+4 more

Exclusion Criteria

My heart isn't working well.

I have specific eye conditions identified for the study.

Current enrollment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days

+20 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Phase I

Dose escalation to assess safety and determine dose range for Phase IIa

At least 4 weeks

At least 2 visits in the first month, then monthly visits

Treatment Phase IIa

Cohort expansion to test two dose levels identified in Phase I

Up to approximately 32 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months until death or study cut-off

Contacted by phone

Participant Groups

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.

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.