IPN60300 for Advanced or metastatic solid tumours | Malignant solid tumour

Inclusion criteria

• {"criterion_text":"- (1) Participant must be ≥18 years of age, at the time of signing the informed consent.\n- (10) At the time of screening, a tumour tissue specimen is required for enrolment into the dose escalation and dose optimisation portions of the study for retrospective central laboratory determination\n- (11) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)\n- (12) Have a life expectancy of more than 3 months for disease-related mortality, as evaluated by the investigator\n- (2) Participants with histologically or cytologically documented, locally advanced, or metastatic solid tumours that relapsed or were refractory after being previously treated with standard of care therapy; or for which there is no available established therapy; or standard therapy is contraindicated or not deemed appropriate by the treating investigator.\n- (3) Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.\n- (4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n- (5) 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 studies.\n- (6) Adequate bone marrow function within 7 days before first dose of study intervention\n- (7) Adequate renal function within 7 days before first dose of study intervention\n- (8) Adequate hepatic function or laboratory abnormalities indicating hepatic injury within 7 days before first dose of study intervention\n- (9) Prothrombin time or international normalised ratio (INR) ≤1.5 × ULN"}

Exclusion criteria

• {"criterion_text":"- (1) Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of study intervention within the last 2 years prior to first dose of study intervention.\n- (10) History of noninfectious interstitial lung disease (ILD)/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.\n- (11) Clinically significant gastrointestinal disorder including bleeding, occlusion, diarrhoea >Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.\n- (12) Any evidence of severe active infection or inflammatory condition\n- (13) Significant concurrent, uncontrolled medical condition that would put participants at unacceptable risk from study participation or preclude them from complying with study procedures as per investigator assessment\n- (14) Participants with uncontrolled human immunodeficiency virus (HIV). HIV-infected participants are eligible if they meet the criteria described in protocol\n- (15) Known active infection with hepatitis B virus (HBV) OR hepatitis C virus (HCV). Participants are eligible if they meet the criteria described in protocol\n- (16) Prior anticancer therapy, including chemotherapy, targeted therapy, therapeutic anticancer antibodies, or radio-/toxin-immunoconjugates\n- (17) Ongoing immunosuppressive therapy, including systemic corticosteroids.\n- (2) Residual toxicity from prior anticancer therapy that are NCI CTCAE version 5.0 Grade 2 or higher. Stable chronic Grade 2 toxicities from previous treatments may be eligible per the judgement of investigator.\n- (3) History of major surgery within 4 weeks prior to the first dose of study intervention\n- (4) Previous solid organ transplantation\n- (5) Pre-existing, acute or chronic severe corneal disorders, sequelae from severe cornedisorders, or a history of corneal transplantation\n- (6) Active brain metastases or leptomeningeal metastases with exception to asymptomatic and treated brain metastases\n- (7) History of stroke or significant cerebrovascular disease (ie, transient ischemic attack) within 6 months prior to initiation of study intervention.\n- (8) History of clinically significant cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as NYHA Grade 2 or higher\n- (9) History of clinically significant respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma."}

Primary endpoints

• {"endpoint_text":"- Phase Ia: - Percentage of participants with dose limiting toxicity (DLT). Cycle1: within 21 days following study drug administration.","definition_or_measurement_approach":"Dose limiting toxicity (DLT) measured during Cycle 1 (within 21 days following study drug administration); percentage of participants with DLT."}
• {"endpoint_text":"- Phase Ia and Ib: - Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE-SAEs). From the first IPN60300 administration until 30 days after the last dose","definition_or_measurement_approach":"Proportion of participants experiencing TEAEs and TE-SAEs from first IPN60300 administration until 30 days after last dose; events classified per standard adverse event reporting."}
• {"endpoint_text":"- Phase Ib: Objective response rate (ORR) - 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. At end of study (up to approximately 3 years)","definition_or_measurement_approach":"ORR per investigator assessment using RECIST v1.1: percentage with BOR of CR or PR; assessed through end of study (up to ~3 years)."}

Secondary endpoints

• {"endpoint_text":"- Phase Ia and Ib: - Percentage of Treatment-Emergent Anti-Drug Antibodies (ADA), Including Binding and Neutralizing Antibodies. Prior study drug administration until the End of Treatment (EoT) visit (approximately up to 3 years)","definition_or_measurement_approach":"Percentage of participants developing treatment-emergent ADAs (binding and neutralizing) measured from prior study drug administration until EoT visit (up to ~3 years)."}
• {"endpoint_text":"- Phase Ia: Time to maximum observed drug concentration (tmax) of IPN60300 after single and multiple doses of IPN60300. At Cycle 1 and Cycle 2: within 21 days following study drug administration","definition_or_measurement_approach":"tmax measured at Cycles 1 and 2 within 21 days following study drug administration after single and multiple doses."}
• {"endpoint_text":"- Phase Ia - Maximum observed drug concentration (cmax) of IPN60300 after single and multiple doses of IPN60300. At Cycles 1 and 2: Within 21 days following study drug administration","definition_or_measurement_approach":"Cmax measured at Cycles 1 and 2 within 21 days following administration after single and multiple doses."}
• {"endpoint_text":"- Phase Ia - Area under the plasma concentration time curve over one dosing interval (AUCtau) of IPN60300 after single and multiple doses of IPN60300. At Cycles 1 and 2: Within 21 days following study drug administration","definition_or_measurement_approach":"AUCtau measured at Cycles 1 and 2 within 21 days following administration for single and multiple doses."}
• {"endpoint_text":"- Phase Ia - Tmax of Total Antibody after single and multiple doses of IPN60300. At Cycles 1 and 2: Within 21 days following study drug administration.","definition_or_measurement_approach":"Tmax of total antibody measured at Cycles 1 and 2 within 21 days following dosing."}
• {"endpoint_text":"- Phase Ia - Cmax of Total Antibody after single and multiple doses of IPN60300. At Cycles 1 and 2: Within 21 days following study drug administration.","definition_or_measurement_approach":"Cmax of total antibody measured at Cycles 1 and 2 within 21 days following dosing."}
• {"endpoint_text":"- Phase Ia - AUCtau of Total Antibody after single and multiple doses of IPN6030. At Cycles 1 and 2: Within 21 days following study drug administration.","definition_or_measurement_approach":"AUCtau of total antibody measured at Cycles 1 and 2 within 21 days following dosing."}
• {"endpoint_text":"- Phase Ia - Tmax of free toxin after single and multiple doses of IPN60300. At Cycles 1 and 2: Within 21 days following study drug administration.","definition_or_measurement_approach":"Tmax of free toxin measured at Cycles 1 and 2 within 21 days following dosing."}
• {"endpoint_text":"- Phase Ia - Cmax of free toxin after single and multiple doses of IPN60300. At Cycles 1 and 2: Within 21 days following study drug administration.","definition_or_measurement_approach":"Cmax of free toxin measured at Cycles 1 and 2 within 21 days following dosing."}
• {"endpoint_text":"- Phase Ia - AUCtau of free toxin after single and multiple doses of IPN60300. At Cycles 1 and 2: Within 21 days following study drug administration.","definition_or_measurement_approach":"AUCtau of free toxin measured at Cycles 1 and 2 within 21 days following dosing."}
• {"endpoint_text":"- Phase Ia - Objective Response Rate (ORR). ORR is defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1. At end of study (up to approximately 3 years)","definition_or_measurement_approach":"ORR per RECIST v1.1 by investigator assessment through end of study (up to ~3 years)."}
• {"endpoint_text":"- Ph Ib - DoR is defined as the time from the first documented evidence of CR or PR until progressive disease, as determined by investigator per RECIST version 1.1, or death from any cause, whichever occurs first. At end of study (up to approximately 3 years)","definition_or_measurement_approach":"Duration of Response (DoR) measured from first documented CR/PR until progression or death per RECIST v1.1, through end of study (up to ~3 years)."}
• {"endpoint_text":"- Ph Ib - PFS is defined as the time from the date of first IPN60300 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first. At end of study (up to approximately 3 years)","definition_or_measurement_approach":"Progression-Free Survival (PFS) measured from first IPN60300 administration to documented progression or death per RECIST v1.1, through end of study (up to ~3 years)."}
• {"endpoint_text":"- Ph Ib - DCR is defined as the percentage of participants with BOR of CR, PR or stable desease (SD), as determined by investigator per RECIST version 1.1. At end of study (up to approximately 3 years)","definition_or_measurement_approach":"Disease Control Rate (DCR): percentage with BOR of CR, PR, or SD per RECIST v1.1, through end of study (up to ~3 years)."}

France

Earliest CTIS Part Ii Submission Date

05-12-2025

Latest Decision Or Authorization Date

23-12-2025

Processing Time Days

18

Number Of Sites

3

Number Of Participants

28

Spain

Earliest CTIS Part Ii Submission Date

20-02-2026

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

35

Number Of Sites

3

Number Of Participants

27

Primary sponsor

Full Name

Ipsen Pharma

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

codes:1,10,12,13,2,5,6

Name

Parexel International (IRL) Limited

Responsibilities

code:8

Name

IQVIA Limited

Responsibilities

SAE coding

Name

Medidata Solutions Inc.

Responsibilities

code:7

Third parties

• {"country":"France","full_name":"Charles River Laboratories Saint-Nazaire","duties_or_roles":"PK samples analysis","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"Biomarker in ctDNA","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"Sample Management","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"S-Clinica","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"Biomarker in PBMC","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaron (Germantown) Lab Services Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes:1,10,12,13,2,5,6","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"Tissue slides analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"SAE coding","organisation_type":"Pharmaceutical company"}