2024-518644-21-01招募中2 期
An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumour Activity of WEF-001 in participants with Advanced KRAS- Mutant Solid Tumours.
Auricula Biosciences Inc.2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2025年12月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Primary Endpoints - Phase 1: 1. Type, incidence and severity of TEAEs, SAEs and abnormal laboratory values per CTCAE v5.0. 2. Frequency of dose interruptions, reductions, and discontinuations. 3. Proportion of participants with DLTs at each dose level.
研究概览
简要总结
Primary Objective: Phase 1
- To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy.
- To establish the MTD and RP2Ds.
Primary Objective: Phase 2a
- To evaluate the antitumour activity following WEF-001 administration as monotherapy.
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 old or older, at the time of signing the informed consent.
- •Have a histologically or cytologically confirmed advanced or metastatic KRAS-mutant tumour. a) Phase 1: KRAS-mutant solid tumours – (PDAC, CRC, NSCLC, platinumresistant serous ovarian cancer, cholangiocarcinoma, or urothelial bladder cancer). b) Phase 2a: One KRAS-mutant solid tumour type to be selected from PDAC, CRC, or NSCLC. Note: See SoA (Section 1.3) for more information on the biopsy sampling.
- •Progressive disease following at least one line of standard of care therapy: a) Patients with Microsatellite instability-high (MSI-H)/ deficient DNA mismatch repair (dMMR) metastatic CRC (mCRC) must have received at least one prior line of therapy with a PD-1 inhibitor. b) Patients with genomic alterations or other biomarkers for which there is approved target therapy for their specific tumor type should have received such therapy.
- •Measurable disease as defined by RECIST v1.1 (Section 10.6).
- •Eastern Cooperative Oncology Group (ECOG) performance status <1 (Section 10.5).
- •Recovered from clinically significant toxicities of prior therapies to Grade ≤1 or baseline, except for alopecia. Participants with ongoing endocrinopathies due to prior treatment that have not resolved but are on appropriate replacement therapy (e.g., thyroid, adrenal or pituitary) are permitted to enroll.
- •Have adequate venous access to allow for blood sampling and IV doses.
- •Adequate organ function, demonstrated by the following laboratory values (Table 5.1). a) If a participant is receiving anticoagulant therapy, an international normalized ratio (INR) >1.5 would be acceptable, if within the expected therapeutic range for the concomitant medication being used, and after discussion with the medical monitor prior to enrollment.
排除标准
- •Any active systemic infection requiring anti-infective therapy within 28 days prior to first dose of IMP.
- •Prior/Concurrent Clinical Study Experience: Are currently enrolled in, or discontinued within 30 days prior to first dose from, a clinical trial involving an investigational product, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Are pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study medication. Participants who have stopped breastfeeding may be enrolled.
- •Currently employed at Auricula Biosciences, or study-associated Contract Research Organization employees; investigator or site personnel directly affiliated with this study and their immediate families.
- •Have an active cardiovascular disease, including: a. Unstable angina b. Myocardial infarction within 6 months prior to study drug administration c. New York Heart Association (NYHA) Class III or IV heart failure d. Electrocardiogram (ECG) abnormality that, in the opinion of the investigator, increases the risks associated with participating in the study e. Electrocardiogram (ECG) abnormality: QTc (Fredericia) >470ms
- •Have a second active primary malignancy, requiring systemic administration of any cancer-related therapy, with the exception of luteinizing hormone-releasing hormone analogs.
- •Have a clinical diagnosis of child-Pugh B or C liver disease.
- •Participants with untreated brain metastases and/or who are neurologically unstable and/or who are not receiving a stable or decreasing corticosteroid dose may not be included in the study.
- •Have a diagnosis of inflammatory bowel disease.
- •Have active and untreated hyperthyroidism.
- •Have a history (within the past 5 years) of, or presence of, systemic lupus erythematosus.
- •Have any other concurrent severe and/or uncontrolled medical or surgical condition which, in the view of the investigator, could compromise the participant’s involvement in the trial due to safety, compliance concerns or ability to evaluate response.
结局指标
主要结局
Primary Endpoints - Phase 1: 1. Type, incidence and severity of TEAEs, SAEs and abnormal laboratory values per CTCAE v5.0. 2. Frequency of dose interruptions, reductions, and discontinuations. 3. Proportion of participants with DLTs at each dose level.
Primary Endpoints - Phase 1: 1. Type, incidence and severity of TEAEs, SAEs and abnormal laboratory values per CTCAE v5.0. 2. Frequency of dose interruptions, reductions, and discontinuations. 3. Proportion of participants with DLTs at each dose level.
Primary Endpoints - Phase 2a: 1. ORR according to RECIST v 1.1.
Primary Endpoints - Phase 2a: 1. ORR according to RECIST v 1.1.
次要结局
- Secondary Endpoints - Phase 1: 1. PK parameters including, but not limited to a. AUC, b. Cmax, c. Tmax, d. T1/2 e. Clearance, f. Vd. 2. BOR, with calculation of ORR as a sum of CR or PR, and DCR as a sum of CR, PR, or SD, PFS, TTR and DOR according to RECIST v 1.1.
- Secondary Endpoints - Phase 2a: 1. DCR, DOR, and PFS according to RECIST v 1.1. 2. Type, incidence and severity of TEAEs, SAEs and clinical laboratory abnormalities per CTCAE v5.0. 3. Frequency of dose interruptions, reductions, and discontinuations. 4. PK parameters including, but not limited to a. AUC, b. Cmax, c. Tmax, d. T1/2, e. Clearance, f. Vd.
研究者
Cynthia Cardinal
Scientific
Auricula Biosciences Inc.
研究点 (2)
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