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A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours
EU CTIS ID: 2024-519184-18-00
What this study is testing
Part A Dose Escalation To evaluate safety and tolerability of IPN01195 and determine the MTD/MAD. To determine the pharmacologically active dose range of IPN01195. Part B Dose Confirmation To determine the optimal dose of IPN01195 in selected tumour type(s).
- 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 or the country’s legal age of majority if the legal age is more than 18 years at the time of signing the informed consent.
- Participants with confirmed diagnosis of advanced or unresectable or recurrent solid tumor who have progressed on prior standard treatment or could not tolerate or are not eligible for standard treatment, or for whom no standard treatment to improve the disease outcome is available
- Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.
- Part A: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for central confirmation of mutation status.
- Part B: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for MAPK genomic testing to confirm eligibility.
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
You likely can't join if
- Gastrointestinal conditions that could impair absorption of IPN01195 (specific cases e.g. remote history of gastrointestinal surgery, may be enrolled after discussion with the medical monitor)
- Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
- Washout period of less than 28 days prior anti-cancer therapy (including chemotherapy, targeted agents, radiotherapy). If the participant was treated with an agent having a short half-life, washout can be <28 days but not shorter than 5 times the half-life.
- Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of the study intervention.
- Non-adequate bone marrow function
- Non-adequate renal function
See the full eligibility criteria
Who can join
- Participants must be ≥18 years of age or the country’s legal age of majority if the legal age is more than 18 years at the time of signing the informed consent.
- Participants with confirmed diagnosis of advanced or unresectable or recurrent solid tumor who have progressed on prior standard treatment or could not tolerate or are not eligible for standard treatment, or for whom no standard treatment to improve the disease outcome is available
- Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.
- Part A: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for central confirmation of mutation status.
- Part B: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for MAPK genomic testing to confirm eligibility.
- 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
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
What rules you out
- Gastrointestinal conditions that could impair absorption of IPN01195 (specific cases e.g. remote history of gastrointestinal surgery, may be enrolled after discussion with the medical monitor)
- Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
- Washout period of less than 28 days prior anti-cancer therapy (including chemotherapy, targeted agents, radiotherapy). If the participant was treated with an agent having a short half-life, washout can be <28 days but not shorter than 5 times the half-life.
- Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of the study intervention.
- Non-adequate bone marrow function
- Non-adequate renal function
- Non-adequate hepatic function
- Known human immunodeficiency virus (HIV) infection. HIV testing will be performed in any countries where mandatory per local requirements.
- Known uncontrolled or untreated hepatitis infection. (a) Known uncontrolled hepatitis B virus (HBV) infection. (b) Known untreated current hepatitis C virus (HCV) infection.
- Sensitivity to IPN01195 or any of its components.
- Any evidence of severe active infection or inflammatory condition.
- Non-adequate cardiac function
- 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, in the investigator’s or sponsor’s opinion, will obscure the interpretation of toxicity determination or AEs.
- Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of the study intervention.
- Active brain metastases or leptomeningeal
- Current enrolment or past participation in any other clinical studies involving an investigational study treatment within the last 28 days
- Live vaccine(s) within 28 days prior to first dose of the study intervention or plan to receive such vaccines during the study.
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.