Clinical trial · Interventional
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours
NCT06305247CI-TRIAL-00124883active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 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. In this study, all participants will receive the study drug, which will be taken by mouth (orally).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IPN01194 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase I (Dose Escalation with Backfilling)
- description
- Nine dose levels are planned to be tested.
- interventionNames
- Drug: IPN01194
- type
- EXPERIMENTAL
- label
- Phase IIa (Cohort Expansion)
- description
- Study intervention will be administered at one of two doses of interest determined at the end of Phase I.
- interventionNames
- Drug: IPN01194
Primary outcomes (4)
- measure
- Phase 1: Percentage of participants with dose limiting toxicity (DLT)
- timeFrame
- Within 28 days of first dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria : * Participants must be ≥18 years of age * Participants with histologically confirmed metastatic solid tumour (melanoma, metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head and neck squamous cell carcinoma (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. Exclusion Criteria * Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications. * Any evidence of severe active infection or inflammatory condition. * 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. * 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). * Active brain metastases or leptomeningeal metastases * 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. * Non-adequate bone marrow function * Non-adequate renal function * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.