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A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
EU CTIS ID: 2023-506228-10-00
What this study is testing
1. Phase 1: Percentage of participants with dose limiting toxicity (DLT) 2. Phase 1: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TE SAEs). 3. Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations 4. Phase 2a: Objective response rate (ORR)
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be ≥18 years of age
- Participants with histologically confirmed metastatic solid tumour (melanoma, CRC, PDAC or 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
You likely can't join if
- Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications
- Non-adequate bone marrow function
- Non-adequate renal function
- Any evidence of severe active infection or inflammatory condition
- Non-adequate hepatic function
- Non adequate coagulation function
See the full eligibility criteria
- Participants must be ≥18 years of age
- Participants with histologically confirmed metastatic solid tumour (melanoma, CRC, PDAC or 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
- Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications
- Non-adequate bone marrow function
- Non-adequate renal function
- Any evidence of severe active infection or inflammatory condition
- Non-adequate hepatic function
- Non adequate coagulation function
- Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C
- Sensitivity to IPN01194 or any of its components
- 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
- Active brain metastases or leptomeningeal metastases
- Underlying medical conditions that, in the investigator’s or sponsor’s opinion, will obscure the interpretation of toxicity determination or AEs
- Known second malignancy within the last 2 years prior to first dose of study intervention
- Major surgery within 28 days prior to first dose of study intervention
- Ongoing AEs caused by any prior anti-cancer therapy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0).
- France-specific: participants under court protection, not affiliated to a social security system or protected adults.
- Current enrolment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days
- Live vaccine(s) within 28 days prior to first dose of study intervention
- Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
- Treatment with medications that prolong the QT/QTc interval
- Treatment with strong and moderate CYP3A4 inducers
- Treatment with strong or moderate inhibitors of CYP3A4
- ONLY for Phase I participants assigned to dose escalation and low-dose backfill participants: treatment with proton pump inhibitors within 14 days prior to first dose of study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.