A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours (NCT06305247) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
United States, France, Spain36 participantsStarted 2024-04-03
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria :
* Participants must be ≥18 years of age
* Participants with histologically confirmed metastatic solid tumour (melanoma, metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head and neck squamous cell carcinoma (HNSCC)) for whom no suitable alternative standard therapy exists.
* Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm).
* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
* Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1.
* Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening
* Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.
Exclusion Criteria
* Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications.
* Any evidence of severe active infection or inflammatory condition.
* Non-adequate cardiac function
* Have one or more of study defined ophthalmological findings/conditions
* Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant's ability to cooperate with the requirements of the study.
* Underlying medical conditions that…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is in Phase 1/Phase 2 and is actively measuring dose-limiting toxicities and serious adverse events, what does that mean for how much is currently known about the safety of IPN01194 — and how would that factor into your recommendation for me?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — is there any possibility I could still be considered, or are there similar trials testing IPN01194 or drugs like it that I should be looking at instead?
3This trial targets several different cancer types including melanoma, head and neck squamous cell carcinoma, pancreatic cancer, and colorectal cancer — given my specific diagnosis, do you think my cancer type would be a good fit for a drug like IPN01194 based on what's known so far?
4The Phase 2a part of this study is measuring objective response rate, meaning how many patients' tumors shrink or respond — based on early signals from trials like this, do you think there's enough preliminary data to know whether IPN01194 might be worth pursuing over standard treatment options for my situation?
5Since Phase 1 trials are primarily designed to find the right dose and identify side effects rather than prove the treatment works, how would you weigh the potential risks of an experimental drug at this stage against other treatment paths available to me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Percentage of participants with dose limiting toxicity (DLT)
Timeframe: Within 28 days of first dose
2
Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs)
Timeframe: At 30 days following the last administration of study intervention
3
Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations
Timeframe: At 30 days following the last administration of study intervention
4
Phase 2a: Objective response rate (ORR)
Timeframe: At end of treatment (up to approximately 32 months)