IPN01195: IPN01195 will be administered at assigned dose level.
Study summary
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 histologically confirmed metastatic solid tumour for whom no suitable alternative standard therapy exists.
* 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.
Exclusion Criteria:
* 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)
* 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.
* 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.
Primary outcome measure(s)
Part A: Percentage of participants with dose limiting toxicity (DLT) — Part A: within 28 days of first dose.
Part A and B: Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs). — From the first IPN01195 administration to 30 days after last dose. An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.
Part A and B: Percentage of participants with dose interruptions and permanent treatment discontinuations — From the first study drug administration to 30 days after last dose.
Part B: Objective response rate (ORR) — Part B: At end of study (up to approximately 3 years) Objective response rate is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator per RECIST version 1.1.
Trial sites (13)
Facility
City
Region
Status
START Mid-West
Grand Rapids
Michigan
Recruiting
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville
Tennessee
Recruiting
Mary Crowley Cancer Research Centers - Medical City Hospital - Dallas
Dallas
Texas
Recruiting
START Mountan Region
West Valley City
Utah
Recruiting
Virginia Cancer Specialist- Fairfax
Fairfax
Virginia
Recruiting
Centre Léon Bérard - Lyon
Lyon
France
Not Yet Recruiting
Paris Saint-Louis
Paris
France
Recruiting
IGR-Villejuif
Villejuif
France
Recruiting
Istituto Nazionale dei Tumori
Milan
Italy
Recruiting
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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