IPN01194 for Pancreatic ductal adenocarcinoma | Melanoma | Head and neck squamous cell carcinoma | Colorectal cancer | Solid tumors

Inclusion criteria

• {"criterion_text":"- Participants must be ≥18 years of age"}
• {"criterion_text":"- Participants with histologically confirmed metastatic solid tumour (melanoma, CRC, PDAC or HNSCC) for whom no suitable alternative standard therapy exists"}
• {"criterion_text":"- Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm)."}
• {"criterion_text":"- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1."}
• {"criterion_text":"- Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening"}
• {"criterion_text":"- 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

• {"criterion_text":"- Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications"}
• {"criterion_text":"- Non-adequate bone marrow function"}
• {"criterion_text":"- Non-adequate renal function"}
• {"criterion_text":"- Any evidence of severe active infection or inflammatory condition"}
• {"criterion_text":"- Non-adequate hepatic function"}
• {"criterion_text":"- Non adequate coagulation function"}
• {"criterion_text":"- Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C"}
• {"criterion_text":"- Sensitivity to IPN01194 or any of its components"}
• {"criterion_text":"- Non-adequate cardiac function"}
• {"criterion_text":"- Have one or more of study defined ophthalmological findings/conditions"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Active brain metastases or leptomeningeal metastases"}
• {"criterion_text":"- Underlying medical conditions that, in the investigator’s or sponsor’s opinion, will obscure the interpretation of toxicity determination or AEs"}
• {"criterion_text":"- Known second malignancy within the last 2 years prior to first dose of study intervention"}
• {"criterion_text":"- Major surgery within 28 days prior to first dose of study intervention"}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- France-specific: participants under court protection, not affiliated to a social security system or protected adults."}
• {"criterion_text":"- Current enrolment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days"}
• {"criterion_text":"- Live vaccine(s) within 28 days prior to first dose of study intervention"}
• {"criterion_text":"- Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents)."}
• {"criterion_text":"- Treatment with medications that prolong the QT/QTc interval"}
• {"criterion_text":"- Treatment with strong and moderate CYP3A4 inducers"}
• {"criterion_text":"- Treatment with strong or moderate inhibitors of CYP3A4"}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Phase 1: Percentage of participants with dose limiting toxicity (DLT) [Time Frame: Cycle 1: Day 1 to Day 28]","definition_or_measurement_approach":"DLT incidence measured during Cycle 1 (Day 1 to Day 28)"}
• {"endpoint_text":"- Phase 1: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TE SAEs). An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. [Time Frame: From Cycle 1 Day 1 to 30 days following the last administration of study intervention]","definition_or_measurement_approach":"Incidence of TEAEs and TE SAEs from Cycle 1 Day 1 until 30 days after last dose; AEs defined per study definition"}
• {"endpoint_text":"- Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations [Time Frame: From Cycle 1 Day 1 to 30 days following the last administration of study intervention]","definition_or_measurement_approach":"Proportion of participants with dose interruptions or permanent discontinuation recorded from Cycle 1 Day 1 to 30 days post last dose"}
• {"endpoint_text":"- Phase 2a: Objective response rate (ORR) Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator. [Time Frame: Cycle 1 Day 1 to 12 weeks (up to approximately 32 months)]","definition_or_measurement_approach":"ORR = percentage with BOR of CR or PR per investigator assessment using RECIST v1.1 over specified timeframe"}

Secondary endpoints

• {"endpoint_text":"- Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194 [Time Frame: Cycle 1 Day 1 to Day 28]","definition_or_measurement_approach":"Tmax measured after single and multiple doses during Cycle 1 (Day 1 to Day 28)"}
• {"endpoint_text":"- Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194 [Time Frame: Cycle 1 Day 1 to Day 28]","definition_or_measurement_approach":"Cmax measured after single and multiple doses during Cycle 1 (Day 1 to Day 28)"}
• {"endpoint_text":"- Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194. AUCtau is defined as the concentration of drug over one dosing interval. [Time Frame: Cycle 1 Day 1 to Day 28]","definition_or_measurement_approach":"AUCtau calculated over one dosing interval from plasma concentration-time data during Cycle 1"}
• {"endpoint_text":"- Phase 1: Geometric mean ratio of Cmax of IPN01194 administered in fed state relative to fasted state [Time Frame: From Day -10 to Day -1 before baseline (Cycle 1 Day 1)]","definition_or_measurement_approach":"Geometric mean ratio of fed vs fasted Cmax measured in pre-baseline window Day -10 to Day -1"}
• {"endpoint_text":"- Phase 1: Geometric mean ratio of AUClast of IPN01194 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: From Day -10 to Day -1 before baseline (Cycle 1 Day 1)]","definition_or_measurement_approach":"Geometric mean ratio of AUClast (time 0 to last observed concentration) fed vs fasted measured pre-baseline"}
• {"endpoint_text":"- Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state. AUCinf is defined as the concentration of drug extrapolated to infinite time. [Time Frame: From Day -10 to Day -1 before baseline (Cycle 1 Day 1)]","definition_or_measurement_approach":"Geometric mean ratio of AUCinf (extrapolated to infinity) fed vs fasted measured pre-baseline"}
• {"endpoint_text":"- Phase 1: 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: Cycle 1 Day 1 to Day 28]","definition_or_measurement_approach":"QTc prolongation evaluated as upper bound of 90% CI for change from baseline over Cycle 1 at highest exposure"}
• {"endpoint_text":"- Phase 1: 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). [Time Frame: Cycle 1 Day 1 to 12 weeks]","definition_or_measurement_approach":"ORR per investigator assessment (BOR of CR or PR) using RECIST v1.1"}
• {"endpoint_text":"- Phase 2a: Duration of response (DoR). Defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1 [Time Frame: From randomisation to end of treatment (up to approximately 32 months)]","definition_or_measurement_approach":"DoR measured from randomisation to end of treatment for participants with BOR of CR or PR (RECIST v1.1)"}
• {"endpoint_text":"- Phase 2a: Progression-free survival (PFS). PFS is defined as the time from the date of randomisation to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1. [Time Frame: From randomisation to end of treatment (approximately 32 months)]","definition_or_measurement_approach":"PFS measured as time from randomisation to first documented progression per RECIST v1.1"}
• {"endpoint_text":"- Phase 2a: PFS rate at 4 months [Time Frame: From randomisation to 4 months]","definition_or_measurement_approach":"Proportion of participants progression-free at 4 months after randomisation"}
• {"endpoint_text":"- Phase 2a: DCR. DCR is defined as the percentage of participants with BOR of CR, PR or SD, as determined by investigator per RECIST version 1.1. [Time Frame: Cycle 1 Day 1 to end of treatment (approximately 32 months)]","definition_or_measurement_approach":"Disease control rate = percentage with BOR of CR, PR or SD per RECIST v1.1"}
• {"endpoint_text":"- Phase 2a: Percentage of participants with TEAEs and TE SAEs [Time Frame: Cycle 1 Day 1 to end of treatment (up to approximately 32 months)]","definition_or_measurement_approach":"Incidence of TEAEs and TE SAEs from Cycle 1 Day 1 to end of treatment"}
• {"endpoint_text":"- Phase 2a: Percentage of participants with dose interruptions and permanent treatment discontinuations [Time Frame: Cycle 1 Day 1 to end of treatment (up to approximately 32 months)]","definition_or_measurement_approach":"Proportion of participants with dose interruptions or permanent discontinuation recorded from Cycle 1 Day 1 to end of treatment"}

Spain

Earliest CTIS Part Ii Submission Date

08-04-2024

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

756

Number Of Sites

3

Number Of Participants

17

France

Earliest CTIS Part Ii Submission Date

24-04-2024

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

740

Number Of Sites

4

Number Of Participants

19

Primary sponsor

Full Name

Ipsen Pharma

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Multiple sponsor/CRO activities (sponsorDuties codes: 1,10,11,12,13,2,5,6,8,9) per CTIS record

Third parties

• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Central lab - logistics","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Cognizant Technology Solutions India Private Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Italy","full_name":"Aptuit (Verona) S.r.l.","duties_or_roles":"PD biomarker in PBMC","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient expenses reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Belgium","full_name":"S-Clinica","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Clario","duties_or_roles":"Central cardiac assessment","organisation_type":"Health care"}
• {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"PD Biomarker in ctDNA & confirmatory mutation testing lab","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Kymos S.L.","duties_or_roles":"PK testing lab","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Cell&Co","duties_or_roles":"Biobanking","organisation_type":"Pharmaceutical company"}