IPN01194 as Single Agent in Advanced Solid Tumors

What is the Purpose of this Study?

The purpose of this study is to evaluate an experimental drug called IPN01194 in people with selected mutations in advanced solid cancers. IPN01194 is a small molecule targeting a pathway called MAPK, which is frequently mutated in solid tumors. These mutations play a key role in tumor growth and drug resistance. IPN01194 aims to inhibit this pathway and is being studied to treat selected tumors such as melanoma, head and neck cancer, colorectal, pancreatic cancers or other solid tumors with MAPK mutations. Researchers will evaluate the safety, tolerability and anti-tumor activity of IPN01194. The study will also examine the pharmacodynamics (what the study drug does to the tumor) and pharmacokinetics (how the body handles IPN01194, including how it is eliminated).

Eligibility

* 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

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.

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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

What is the full name of this clinical trial?

CLIN-01194-450: An open-label, phase I/IIa first-in-human, dose escalation and cohort expansion study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and anti-tumour activity of ERK1/2 inhibitor IPN01194 as single agent in adult participants with advanced solid tumours

Study Details

Disease Type/Condition

Colon, Lip, Oral Cavity and Pharynx, Melanoma, Pancreas

Principal Investigator

Hamid, Omid

Co-Investigators

Cathie T Chung, Inderjit Mehmi, Iryna Singh, Justin Moyers, Kristopher Wentzel, Navid Hafez, Vi K. Chiu

Age Group

Adult

Phase

I/II

IRB Number

STUDY00003319

ClinicalTrials.gov ID

NCT06305247

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org