CTRI/2025/01/078964招募中1 期
A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 in Patients with Relapsed Advanced Lymphoma (ADITI-1)
Aurigene Oncology Limited (Subsidiary of Dr Reddys Laboratories Limited )20 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 20
- 主要终点
- Primary Endpoints:
研究概览
简要总结
The study will have two parts: a Dose Escalation Part (Part 1) and Dose Expansion Part (Part 2).
In Part 1, initially, cancer patients who do not have any available curative treatment options and have exhausted all effective therapies will be enrolled in a traditional 3 +3 design in order to evaluate the safety, tolerability, PK/PD, and determine dose(s) of AUR112 as a single agent which will be investigated in future trials
In Part 2, expansion cohorts in relevant tumor types will be enrolled at the dose(s) to gather preliminary efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males and females more than or equal to 18 years of age 2.ECOG of 0 or 1 3.Acceptable bone marrow and organ function at screening as described below: a.
- •ANC more than or equal to 1000/microL (without WBC growth factor support) b.
- •Platelet count: For patients with CLL more than or equal to 50,000/microL; For patients with lymphomas more than or equal to 75,000/microL without bone marrow involvement and more than or equal to 50,000/microL with bone marrow involvement.
- •These thresholds should be qualified without platelet transfusion support.
- •Hemoglobin more than or equal to 9 g/dL (RBC Transfusion is allowed to achieve this Hb) d.Total Bilirubin less than or equal to 1.5 x ULN; (Patients with known Gilberts syndrome are allowed with a Total Bilirubin less than or equal to 2.5 x ULN) e.
- •AST (SGOT) less than or equal to 3 x ULN (less than or equal to 5 X ULN if known liver metastases) f.
- •CrCl more than or equal to 60 mL/min
- •Ability to swallow and retain oral medications.
- •Histopathological diagnosis of NHL or CLL or Hodgkin disease.
- •at screening.
- •The lymphomas included in this study must fall within one of the following 2017 World Health Organization categories except lymphoma mentioned in Exclusion criterion #5: Mature B-cell neoplasms (excluding plasma cell neoplasms, heavy chain disease, and primary central nervous system [CNS] lymphoma).
- •Mature T- and NK-cell neoplasms.
- •Hodgkin lymphomas.
- •The CLL should be Binet Stage C/Rai stage III or IV, as per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines.
- •In the case of subjects who have lymphoma for which HD-ASCT is considered a standard curative therapy, eligibility for this study requires that the subjects disease has relapsed after HD-ASCT, or the subject is not eligible for HD-ASCT, or that the subject has refused HD-ASCT.
- •In the case of patients who have lymphoid malignancies for which CAR-T therapy is indicated, eligibility for this study requires that the disease has relapsed after CAR-T, or the patient is not eligible for CAR-T, or the patient has refused CAR-T, or the CAR-T is not available locally.
- •Evidence of measurable disease as per Lugano Criteria for Lymphoma or evidence of measurable disease as per iwCLL Criteria for CLL.
- •Note: Patients with Small Lymphocytic Lymphoma (SLL) alone or in combination with CLL are allowed.
- •Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally.
- •The patients must have relapsed or refractory to at least 2 prior lines of systemic therapies for NHL or CLL, or Hodgkin disease.
- •Note: Any cancer patient with access to any effective therapy locally must not be enrolled.
- •Patients with CLL should have documented evidence for progressive or symptomatic disease (active disease) and must have indications for treatment.
- •Patients with indolent lymphomas also must have indications for treatment, such as the GELF (Brice et al 1997) or BNLI criterion.
排除标准
- •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.
- •Note: Concomitant use of low dose prednisone is allowed.
- •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 less than or equal to 1, as determined by NCI CTCAE
- •Definitive Radiotherapy within the last 21 days of Cycle 1 Day
- •Use of any investigational agent within 28 days or 5 halflives prior to Cycle 1 Day 1
- •Patients with Burkitts lymphoma, Burkitt-like lymphoma, post-transplant lymphoproliferative disease, primary mediastinal large-B cell lymphoma, cutaneous lymphomas, mycosis fungoides, or Sezary syndrome.
- •Known symptomatic or untreated or recently treated CNS lymphoma.
- •Patients with previously treated CNS lymphoma and are now stable and asymptomatic, from CNS perspective, are allowed.
- •Patients with lymphoma that requires immediate cytoreductive therapy.
- •Patients with low-grade lymphoma or indolent lymphoma that does not meet conventional criteria for requiring treatment.
- •Patients on drugs which are inhibitors of P-gp or BCRP or UGT1A1 and when these drugs cannot be discontinued from at least one week prior to Cycle 1 Day
- •Note: These drugs will be prohibited during Cycle 1 of therapy.
- •Major surgery less than 28 days from Cycle 1 Day 1
- •Active infection requiring systemic therapy.
- •Note: Prophylactic use of antibiotics is allowed.
- •Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed.
- •Known to be HIV positive or have an acquired immunodeficiency syndrome-related illness.
- •Known active or chronic hepatitis B or hepatitis C infection.
- •Uncontrolled congestive heart failure, angina, myocardial infarction, cerebrovascular accident, cCABG, or TIA, or pulmonary embolism within 3 months prior to Cycle 1 Day
- •Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day
- •QTcF interval more than 470 ms on ECG at screening or at Cycle 1 Day 1 pre-dose.
- •Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding diatheses, presence of any major medical illness, which, in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results or the patients ability to participate in the study.
- •Current swab-positive or suspected Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of personwith confirmed Covid-19 infection, at screening or Cycle 1 Day
- •History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study.
- •Positive pregnancy test for WOCBP at the screening or enrolment visit.
- •Lactating women or WOCBP or a man with a partner who has childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods during the screening period, while on AUR112 and at least 28 days after last dose.
结局指标
主要结局
Primary Endpoints:
时间窗: 28 DAYS
To assess the safety and tolerability of single agent AUR112 in patients with relapsed advanced lymphoid malignancies
时间窗: 28 DAYS
To assess the PK profile of AUR112.
时间窗: 28 DAYS
To determine the doses to be recommended for evaluation in future studies.
时间窗: 28 DAYS
次要结局
- Exploratory Endpoints:(To explore the pharmacodynamics (PD) effects of AUR112)
研究者
Dr Akhil Kumar
Aurigene Oncology Limited (Subsidiary of Dr Reddys Laboratories Limited )
研究点 (20)
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