IPN01195 for Advanced solid tumour

Inclusion criteria

• {"criterion_text":"- 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.\n- Participants with confirmed diagnosis of advanced or unresectable or recurrent solid tumor who have progressed on prior standard treatment or could not tolerate or are not eligible for standard treatment, or for whom no standard treatment to improve the disease outcome is available\n- Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.\n- 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.\n- 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.\n- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1\n- Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1\n- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n- 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

• {"criterion_text":"- 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)\n- Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).\n- 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.\n- 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.\n- Non-adequate bone marrow function\n- Non-adequate renal function\n- Non-adequate hepatic function\n- Known human immunodeficiency virus (HIV) infection. HIV testing will be performed in any countries where mandatory per local requirements.\n- Known uncontrolled or untreated hepatitis infection. (a) Known uncontrolled hepatitis B virus (HBV) infection. (b) Known untreated current hepatitis C virus (HCV) infection.\n- Sensitivity to IPN01195 or any of its components.\n- Any evidence of severe active infection or inflammatory condition.\n- Non-adequate cardiac function\n- 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.\n- Underlying medical conditions that, in the investigator’s or sponsor’s opinion, will obscure the interpretation of toxicity determination or AEs.\n- Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of the study intervention.\n- Active brain metastases or leptomeningeal\n- Current enrolment or past participation in any other clinical studies involving an investigational study treatment within the last 28 days\n- Live vaccine(s) within 28 days prior to first dose of the study intervention or plan to receive such vaccines during the study."}

Primary endpoints

• {"endpoint_text":"- Part A: Percentage of participants with dose limiting toxicity (DLT) [Time Frame: Part A: within 28 days of first dose.]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part A and B: Percentage of participants experiencing emergent serious adverse events (TE SAEs). [Time Frame: From the first IPN01195 administration to 30 days after last dose.]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part A and B: Percentage of participants with dose interruptions and permanent treatment discontinuations [Time Frame: From the first study drug administration to 30 days after last dose.]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part B: Objective response rate (ORR) 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. [Time Frame: Part B: At end of study (up to approximately 3 years)]","definition_or_measurement_approach":"ORR defined as percentage of participants with BOR of CR or PR as determined by investigator per RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- Part A: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01195 [Time Frame: Cycle 1: at Day 1 and at Day 15.]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part A: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01195 [Time Frame: Cycle 1: at Day 1 and at Day 15.]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part A: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01195 AUCtau is defined as the concentration of drug over one dosing interval. [Time Frame: Cycle 1: at Day 1 and at Day 15.]","definition_or_measurement_approach":"AUCtau defined as concentration of drug over one dosing interval."}
• {"endpoint_text":"- Part A: Geometric mean ratio of Cmax of IPN01195 administered in fed state relative to fasted state. [Time Frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part A: Geometric mean ratio of AUClast of IPN01195 administered in fed state relative to fasted state AUClast is defined as the concentration of drug from time zero to the last observable concentration. [Time Frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)]","definition_or_measurement_approach":"AUClast defined as concentration of drug from time zero to last observable concentration."}
• {"endpoint_text":"- Part A: Geometric mean ratio of AUCinf of IPN01195 administered in fed state relative to fasted state AUCinf is defined as the concentration of drug extrapolated to infinite time. [Time Frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)]","definition_or_measurement_approach":"AUCinf defined as concentration of drug extrapolated to infinite time."}
• {"endpoint_text":"- Part A: Prolongation of corrected QT interval (QTc) Prolongation of QTc defined as the upper limit of 90% confidence interval for change from baseline QTc evaluated over Cycle 1 at the highest clinically relevant exposure. [Time Frame: Within 28 days of first dose.]","definition_or_measurement_approach":"Prolongation of QTc defined as upper limit of 90% CI for change from baseline QTc evaluated over Cycle 1 at highest clinically relevant exposure."}
• {"endpoint_text":"- Part A: Objective response rate (ORR) The ORR 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 [Time Frame: Part A: From first study drug administration to end of study (up to approximately 3 years)]","definition_or_measurement_approach":"ORR defined as percentage of participants with BOR of CR or PR per investigator assessment using RECIST v1.1."}
• {"endpoint_text":"- Part B: Duration of response (DoR) DoR defined as the time from first documented evidence of CR or PR until progressive disease, as determined by investigator per RECIST version 1.1. [Time Frame: Every 3 months until end of study or death (up to approximately 3 years)]","definition_or_measurement_approach":"DoR defined as time from first documented CR or PR until progressive disease per investigator using RECIST v1.1."}
• {"endpoint_text":"- Part B: Progression-free survival (PFS) PFS is defined as the time from the date of first IPN01195 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1. [Time Frame: From first study drug administration to end of study (up to approximately 3 years)]","definition_or_measurement_approach":"PFS defined as time from first IPN01195 administration to first documented disease progression per investigator using RECIST v1.1."}
• {"endpoint_text":"- Part B: PFS rate at 4 months PFS rate at 4 months defined as the proportion of participants who remain alive and progression-free at 4 months, as determined by investigator per RECIST version 1.1. [Time Frame: At Month 4]","definition_or_measurement_approach":"PFS rate at 4 months defined as proportion alive and progression-free at 4 months per investigator using RECIST v1.1."}
• {"endpoint_text":"- Part B: Disease control rate (DCR). DCR is defined as the percentage of participants with BOR of CR, PR or stable disease (SD), as determined by investigator per RECIST version 1.1 [Time Frame: Part B:From first study drug administration to end of study (up to approximately 3 years)]","definition_or_measurement_approach":"DCR defined as percentage with BOR of CR, PR or SD per investigator using RECIST v1.1."}

Italy

Earliest CTIS Part Ii Submission Date

31-03-2025

Latest Decision Or Authorization Date

23-04-2025

Processing Time Days

23

Number Of Sites

2

Number Of Participants

8

Spain

Earliest CTIS Part Ii Submission Date

02-04-2025

Latest Decision Or Authorization Date

22-04-2025

Processing Time Days

20

Number Of Sites

3

Number Of Participants

9

France

Earliest CTIS Part Ii Submission Date

02-04-2025

Latest Decision Or Authorization Date

22-04-2025

Processing Time Days

20

Number Of Sites

3

Number Of Participants

9

Primary sponsor

Full Name

Ipsen Pharma

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Codes/roles: 1,10,11,12,13,2,5,6,8,9 (as listed in sponsor duties)

Third parties

• {"country":"Belgium","full_name":"S-Clinica","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central Cardiac Assessment","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Drug Depot","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"1,10,11,12,13,2,5,6,8,9","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Samples Managment & Interim Storage","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Kymos S.L.","duties_or_roles":"Pharmacokinetic testing (in blood samples); 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Aptuit (Verona) S.r.l.","duties_or_roles":"Testing lab for PD (in PBMC samples); 4","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"Testing lab for Pharmacodynamic in ctDNA & Screening tumor biopsy samples; 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Foundation Medicine, Inc.","duties_or_roles":"Testing lab for Pharmacodynamic in ctDNA & Screening tumor biopsy samples; 4","organisation_type":"Industry"}
• {"country":"France","full_name":"Cryoport France","duties_or_roles":"Biobanking","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Samples Management & Interim storage","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Drug Depot","organisation_type":"Pharmaceutical company"}