2025-522184-15-00招募中2 期
An Open-label, Phase I/II First in Human, Dose Escalation, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Participants With Locally Advanced or Metastatic Solid Tumours Who Have Progressed on or After Immune Checkpoint Inhibitor Therapies
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Ipsen Pharma
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Ph Ia 1. Percentage of participants with dose limiting toxicity (DLT)
研究概览
简要总结
Phase Ia To evaluate the safety and tolerability of IPN01203 as a single agent and determine the MTD/MAD in participants with selected tumours Phase Ib To determine the optimal dosing regimen of IPN01203 in selected tumours
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up period
- 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
- •Participant must be ≥18 years of age, at the time of signing the informed consent.
- •ECOG performance status of 0 to 1
- •Measurable disease per RECIST version 1.1 (at least one lesion that is measurable by RECIST 1.
- •Tumour lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation) and documented locally advanced or metastatic disease with CT and/or MRI.
- •All acute, clinically significant (CS) treatment-related AEs from a prior therapy resolved to Grade 1 or lower prior to study entry. Participants with chronic toxicities that are stable of moderate intensity (Grade ≤2) and well controlled can be included
- •Have a life expectancy for disease-related mortality, as evaluated by the investigator.
- •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.
- •Adequate haematologic and end organ function
- •Participant is capable of giving signed informed consent as described in the protocol.
排除标准
- •Have untreated or active primary brain tumour, CNS metastases, leptomeningeal disease, or spinal cord compression.
- •For French participants ONLY: participants are under court protection, not affiliated to a social security system or protected adults.
- •Experienced severe, life-threatening immune-mediated AEs, or infusionrelated reactions such as those that lead to permanent discontinuation while on treatment with prior anticancer therapy such as immune checkpoint inhibitor therapy.
- •History of known autoimmune disease
- •History of stroke or significant cerebrovascular disease, encephalitis, meningitis, organic brain disease (e,g., Parkinson’s disease) or uncontrolled seizures in the year prior to first dose of study drug.
- •History of CS 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 New York Heart Association Grade 2 or higher. Additional exclusion criteria include: a. Left ventricular ejection fraction <45% b. QT interval corrected by Fridericia (QTcF) >470 ms (for women) and >450 ms (for men) or CS arrhythmias.
- •History of CS respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.
- •Prior organ transplantation.
- •Chronic or ongoing active infections within 4 weeks prior to C1D
- •Presence of hepatitis B surface antigen (HBsAg) [or hepatitis B core antibody (HBcAb)] at screening or within 3 months prior to the first dose of study intervention.
- •Positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study intervention.
- •Participants with known history of HIV infection are excluded from the study unless they meet the following criteria: a. Stable Antiretroviral Therapy: Participants must be on a stable antiretroviral therapy regimen for at least 4 weeks prior to enrolment. b. CD4+ T cell Count: Participants must have a CD4+ T cell count of at least 200 cells/µL. c. Viral Load: Participants must have an undetectable viral load (HIV RNA <50 copies/mL) d. No Opportunistic Infections: Participants must not have had any opportunistic infections or other human immunodeficiency virus (HIV)-related illness within the past 6 months Note: HIV testing will be performed in any countries where it is mandatory per local requirements.
- •History of other malignancy within the last years.
- •Significant concurrent, uncontrolled medical condition that would put participants at unacceptable risk from study participation or preclude them from complying with study procedures per investigator including, but not limited to renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
- •Treatment with >10 mg per day of prednisone (or equivalent) or other immune suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for participants who have had allergicreaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.
- •Concurrent participation in another therapeutic treatment study.
- •Participants accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised.
结局指标
主要结局
Ph Ia 1. Percentage of participants with dose limiting toxicity (DLT)
Ph Ia 1. Percentage of participants with dose limiting toxicity (DLT)
2. Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs)
2. Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs)
Ph Ib 3. objective response rate (ORR) Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1
Ph Ib 3. objective response rate (ORR) Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1
次要结局
- 5. Objective response rate (ORR)
- Ph Ia 1.Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203
- 2. Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203
- 3. Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203
- 4. Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies
- 6. Ph Ib Duration of response (DoR). DoR is defined as the time from 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
- 7. Duration of stable disease (SD). SD is defined as the time from the date of first IPN01203 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, for participants with SD as best response, with a minimum SD duration of 8 weeks
- 8. Progression-free survival (PFS). PFS is defined as the time from the date of first IPN01203 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.
- 9. Disease control rate (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, from the first IPN01203 administration throughout the study.
- 10. Time to response (TTR). TTR is defined as the time between date of start of treatment until first documented response (CR or PR), as determined by investigator per RECIST version 1.1.
- 11. Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies
研究者
Ipsen Clinical Study Enquiries
Scientific
Ipsen Pharma
研究点 (1)
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