An Open-label, Phase I/II First-in-human, Dose Escalation and Confirmation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Anti-tumour Activity of IPN01195 as Single Agent in Adult Participants With Advanced Solid Tumours
Study Identifier:
CLIN-01195-450
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
Study Contact Information:
N/A
Recruiting
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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.
To evaluate safety, tolerability, PK, PD and antitumour activity of IPN01195 as a single agent.
Phase I will be conducted in two parts: Part A (dose escalation) to determine maximum tolerated dose /pharmacologically active dose range. Part B (dose confirmation) evaluates optimal dosing regimen by assessing safety and preliminary antitumour activity at dose levels of interest.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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.
- Participants (≥18 yrs) should have a confirmed diagnosis of MAPKm advanced solid tumour for whom no standard treatment exists
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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
William McKean
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Manish Sharma
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor