临床试验/2025-522139-33-00

2025-522139-33-00招募中2 期

An Open-Label, Phase I/II First-in-Human, Dose Escalation, Dose Optimisation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 as Single Agent in Adult Participants with Locally Advanced or Metastatic Solid Tumours.

Ipsen Pharma3 个研究点分布在 1 个国家目标入组 28 人开始时间: 2025年12月23日最近更新: 2025年12月23日

试验速览

阶段: 2 期
状态: 招募中
发起方: Ipsen Pharma
入组人数: 28
试验地点: 3
主要终点: Phase Ia: - Percentage of participants with dose limiting toxicity (DLT). Cycle1: within 21 days following study drug administration.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Phase Ia To evaluate the safety and tolerability of IPN60300 as a single agent and determine the MTD/MAD in participants with tumour type of interest Phase Ib To determine the optimal dosing regimen ofIPN60300 in participants with selected tumour(s)

研究设计

分配方式: Randomized
主要目的: Ph Ib, Dose Optimisation
盲法: None

入排标准

年龄范围: 18 years 至 65+ years（65+ Years, 18-64 Years）
接受健康志愿者: 是

入选标准

•(1) Participant must be ≥18 years of age, at the time of signing the informed consent.
•(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
•(11) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
•(12) Have a life expectancy of more than 3 months for disease-related mortality, as evaluated by the investigator
•(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.
•(3) Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.
•(4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
•(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.
•(6) Adequate bone marrow function within 7 days before first dose of study intervention
•(7) Adequate renal function within 7 days before first dose of study intervention
•(8) Adequate hepatic function or laboratory abnormalities indicating hepatic injury within 7 days before first dose of study intervention
•(9) Prothrombin time or international normalised ratio (INR) ≤1.5 × ULN

排除标准

•(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.
•(10) History of noninfectious interstitial lung disease (ILD)/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
•(11) Clinically significant gastrointestinal disorder including bleeding, occlusion, diarrhoea >Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.
•(12) Any evidence of severe active infection or inflammatory condition
•(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
•(14) Participants with uncontrolled human immunodeficiency virus (HIV). HIV-infected participants are eligible if they meet the criteria described in protocol
•(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
•(16) Prior anticancer therapy, including chemotherapy, targeted therapy, therapeutic anticancer antibodies, or radio-/toxin-immunoconjugates
•(17) Ongoing immunosuppressive therapy, including systemic corticosteroids.
•(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.
•(3) History of major surgery within 4 weeks prior to the first dose of study intervention
•(4) Previous solid organ transplantation
•(5) Pre-existing, acute or chronic severe corneal disorders, sequelae from severe cornedisorders, or a history of corneal transplantation
•(6) Active brain metastases or leptomeningeal metastases with exception to asymptomatic and treated brain metastases
•(7) History of stroke or significant cerebrovascular disease (ie, transient ischemic attack) within 6 months prior to initiation of study intervention.
•(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
•(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.

结局指标

主要结局

Phase Ia: - Percentage of participants with dose limiting toxicity (DLT). Cycle1: within 21 days following study drug administration.

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

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)

次要结局

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)
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
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
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
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.
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.
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.
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.
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.
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.
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)
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)
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)
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)

研究者

发起方

Ipsen Pharma

申办方类型

Pharmaceutical company

责任方

Principal Investigator

主要研究者

Ipsen Clinical Study Enquiries

Scientific

Ipsen Pharma

研究点 (3)

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