临床试验/NCT06760702

NCT06760702

终止

2 期

A Phase II, Open-label, Randomized, Dose-ranging Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients With Colorectal, Ovarian, and Renal Cancers (TEJAS-2)

Aurigene Discovery Technologies Limited10 个研究点分布在 1 个国家目标入组 29 人2024年11月9日

适应症Ovarian Cancer Colorectal Cancer Renal Cancer

干预措施AUR109 200mg AUR109 300mg AUR109 400mg

概览

阶段: 2 期
干预措施: AUR109 200mg
疾病 / 适应症: Ovarian Cancer
发起方: Aurigene Discovery Technologies Limited
入组人数: 29
试验地点: 10
主要终点: Safety and Efficacy
状态: 终止
最后更新: 15天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This is an open-label, multicentre, randomized, Phase II study and will be conducted with co-primary objectives of the study are to assess the efficacy of AUR109, as measured by ORR and safety / tolerability at three different dose levels of the study drug in three cancer indications i.e., colorectal, ovarian cancer and renal cancer.

详细描述

This is a Phase II, open-label, multicenter study evaluating the efficacy and safety of the drug AUR109 at three different dose levels (200 mg, 300 mg, and 400 mg) in patients with colorectal, ovarian, or renal cancer. Participants must have undergone at least two lines of systemic therapy and exhausted all local treatment options. The 200 mg and 300 mg doses will be administered continuously over a 21-day cycle, while the 400 mg dose will follow an interrupted regimen (2 weeks on, 1 week off). The drug is to be taken once daily according to the specified dosing schedule.

注册库

clinicaltrials.gov

开始日期

2024年11月9日

结束日期

2026年2月1日

最后更新

15天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Aurigene Discovery Technologies Limited

责任方

Sponsor

入排标准

入选标准

•Provide signed and dated informed consent and agree to comply with all study related activities.
•Male or female patients aged ≥ 18 years.
•Pathological diagnosis of adenocarcinoma of colorectal origin, epithelial ovarian cancer (ovarian cancer term also includes fallopian tube cancer as well as primary peritoneal cancer), or renal cell carcinoma of the kidney.
•Patients must have received at least two lines of systemic therapy and should have exhausted all available local therapies. At a minimum, for each of the respective cancer types, patients should have received the following:
•Colorectal Cancer - Previous treatment should include 5-FU based treatments, oxaliplatin based treatments, irinotecan-based treatments, IV VEGF inhibitors, IV EGFR antibodies (for KRAS wildtype), PD-1 antibodies for known MSI-H positive tumors, regorafenib and lonsurf, anti-HER2 agents (e.g., FDA approved Tucatinib and Trastuzumab combination, where available) for HER2 amplified colorectal cancer, unless any of these are not available locally or prohibitive for the patient financially or if the patient is not eligible for these or if the patient has refused these.
•Ovarian cancer (also includes fallopian tube cancer and primary peritoneal cancer) - Tumor must be platinum refractory, defined as treatment free interval of \< 6 months from the last platinum-based regimen. In addition, patient should have received topotecan, gemcitabine, liposomal doxorubicin, bevacizumab and PARP inhibitors (for BRCA mutants), mirvetuximab for folate receptor alpha amplified ovarian cancer, unless any of these are not available locally or prohibitive for the patient financially or if the patient is not eligible for these or if the patient has refused these.
•Renal Cell Carcinoma - Patient should have received an oral VEGF inhibitor and PD-1/PD-L1 inhibitors, unless any of these are not available locally or prohibitive for the patient financially or if the patient is not eligible for these or if the patient has refused these.
•Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 (Patients with disease related ECOG 2 are allowed, in addition to ECOG 0 and 1).
•Acceptable bone marrow function as described below:
•ANC ≥ 1200/μL (without WBC growth factor support) Platelet count ≥ 90,000/μL without transfusion support Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)

排除标准

•Patients without any wild type allele (Such as \*28/\*28, \*37/\*37 or \*37/\*28 variants) genotypes for UGT1A
•Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or Immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study.
•Presence of an acute or chronic toxicity resulting from prior anti-cancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.
•Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).
•Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day
•Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (\> 6 months of screening) and are now stable and asymptomatic, from CNS perspective, are allowed.
•Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).
•Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
•Known active or chronic hepatitis B or hepatitis C infection.
•Uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day

研究组 & 干预措施

Colorectal cancer

干预措施: AUR109 200mg

Colorectal cancer

干预措施: AUR109 300mg

Colorectal cancer

干预措施: AUR109 400mg

Ovarian Cancer

干预措施: AUR109 200mg

Ovarian Cancer

干预措施: AUR109 300mg

Renal Cancer

干预措施: AUR109 300mg

Ovarian Cancer

干预措施: AUR109 400mg

Renal Cancer

干预措施: AUR109 200mg

Renal Cancer

干预措施: AUR109 400mg

结局指标

主要结局

Safety and Efficacy

时间窗: Baseline, Cycle 2 Day 1,Cycle 4 Day 1,Cycle 6 Day1,Cycle 8 Day 1 and Cycle 10 Day 1 (each cycle is 21 days)

To assess the safety and efficacy of three dose levels of AUR109 (200 mg, 300 mg, and 400 mg) in patients with colorectal, ovarian, and renal cancers, as measured by Objective Tumor Response Rate (ORR) (CR + PR).

次要结局

Pharmacokinetic Profile (Cmax)(Day 1 and Day 15)
Pharmacokinetic Profile (Tmax)(Day 1 and Day 15)
Pharmacokinetic Profile (AUC)(Day 1 and Day 15)
HRQoL(Assessment will be performed at 3 rd week (Day 15 to 21) of every 3 cycles (21 days per Cycle) until either progressive disease or intolerable toxicity occurs)