2024-519184-18-00招募中2 期
An open-label, phase I/II first-in-human, dose escalation and confirmation study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and anti-tumour activity of IPN01195 as single agent in adult participants with advanced solid tumours
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Ipsen Pharma
- 入组人数
- 26
- 试验地点
- 8
- 主要终点
- Part A: Percentage of participants with dose limiting toxicity (DLT) [Time Frame: Part A: within 28 days of first dose.]
研究概览
简要总结
Part A Dose Escalation • To evaluate safety and tolerability of IPN01195 and determine the MTD/MAD. • To determine the pharmacologically active dose range of IPN01195. Part B Dose Confirmation • To determine the optimal dose of IPN01195 in selected tumour type(s).
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
- •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.
- •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
- •Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.
- •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.
- •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.
- •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
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •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.
排除标准
- •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)
- •Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
- •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.
- •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.
- •Non-adequate bone marrow function
- •Non-adequate renal function
- •Non-adequate hepatic function
- •Known human immunodeficiency virus (HIV) infection. HIV testing will be performed in any countries where mandatory per local requirements.
- •Known uncontrolled or untreated hepatitis infection. (a) Known uncontrolled hepatitis B virus (HBV) infection. (b) Known untreated current hepatitis C virus (HCV) infection.
- •Sensitivity to IPN01195 or any of its components.
- •Any evidence of severe active infection or inflammatory condition.
- •Non-adequate cardiac function
- •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 either progressing or requiring active treatment within the last 2 years prior to first dose of the study intervention.
- •Active brain metastases or leptomeningeal
- •Current enrolment or past participation in any other clinical studies involving an investigational study treatment within the last 28 days
- •Live vaccine(s) within 28 days prior to first dose of the study intervention or plan to receive such vaccines during the study.
结局指标
主要结局
Part A: Percentage of participants with dose limiting toxicity (DLT) [Time Frame: Part A: within 28 days of first dose.]
Part A: Percentage of participants with dose limiting toxicity (DLT) [Time Frame: Part A: within 28 days of first dose.]
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.]
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.]
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.]
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.]
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)]
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)]
次要结局
- 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.]
- 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.]
- 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.]
- 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)]
- 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)]
- 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)]
- 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.]
- 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)]
- 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)]
- 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)]
- 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]
- 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)]
研究者
Ipsen Clinical Study Enquiries
Scientific
Ipsen Pharma
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