Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Ipsen (Voir sur ClinicalTrials)
mars 2025
octobre 2028
09 mai 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine HOLLEBECQUE | 14/05/2026 07:20:05 | Contacter | ||
Critères
Tous
- 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.