EUCTR2022-000891-20-IT招募中1 期
An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients with Relapsed or Refractory Hematologic Malignancies - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Curis, Inc.
- 入组人数
- 221
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females >= 18 years of age
- •2. Life expectancy of at least 3 months
- •3. ECOG Performance Status of <= 1
- •4. Diagnosis of histopathologically confirmed B-cell NHL, as per the WHO 2016 classification (Swerdlow et al. 2016). Eligible NHL subtypes include follicular lymphoma, MZL, MCL, DLBCL (including extranodal lymphomas of leg-, testicular-, or not otherwise specified [NOS]-type), and primary or secondary CNS lymphoma. NOTE: Once a dose has been shown not to exceed the MTD in NHL patients, other hematological malignancies can be considered for enrollment in specific malignancies that have been approved by the CSC and Sponsor. Patients with MCL or MZL should meet clinical criteria for requiring treatment of their disease.
- •5. Relapsed or refractory disease (as defined below) for which patients are ineligible for or have exhausted standard therapeutic options that would be considered standard of care.
- •a. Relapsed NHL is per Revised Response Criteria for Malignant Lymphoma and as documented by excisional/incisional biopsy (preferred) or FNA or CNB as PD after a CR, PR, or SD. NOTE: For confirmation of documented relapse during prior treatment, biopsy/FNA of the lymphoma at Screening is recommended but not mandatory.
- •b. Refractory NHL is defined for all eligible NHL by PD (per Revised Response Criteria for Malignant Lymphoma) during prior treatment or failure to achieve an objective response on prior treatment. NOTE: Biopsy (preferred) or FNA at Screening is recommended but not mandatory.
- •6.Measurable disease (as defined below):
- •Defined as CT scan showing at least 1 or more clearly demarcated lymph node(s) with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated extranodal lesion(s) with a long axis > 1.0 cm and short axis > 1.0 cm. All lesions must have a maximum diameter of < 10 cm
- •7.Must have recovered from toxicity after any prior autologous stem cell transplants or CAR-T cell therapy, and must have disease progression prior to initiation of study treatment
- •8.Acceptable marrow and organ function at screening as described below:
- •a. ANC >= 1,000/µL*
- •b. Platelet count >= 50,000/µL without transfusion within 1 week prior to start of study treatment*
- •c. Serum creatinine <= 1.5 × ULN or a calculated creatinine clearance >= 30 mL/min according to Cockcroft-Gault formula (using actual body weight) or by 24-hour urine collection
- •d. AST or ALT <= 2 × ULN
- •e. Total bilirubin <= 1.5 × ULN or <= 3 × ULN in patients with documented Gilbert's syndrome
- •*NOTE: For patients with bone marrow involvement of their disease, eligibility will be determined following discussion between Investigator and Medical Monitor
- •9. Ability to swallow and retain oral medications
- •10. Negative serum pregnancy test in WOCP
- •11. WOCP and men who partner with a WOCP must agree to use highly effective contraceptive methods for the duration of the study and for 3 months after the last dose of study treatment.
- •12. Willing and able to provide written informed consent and comply with the requirements of the trial
- •13. Creatinine Phosphokinase (CPK) < Grade 2
- •14. Patients on a cholesterol lowering statin must be on a stable dose with no changes within 3 weeks prior to study start
- •- Part B. Check protocol for complete list.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •All exclusion criteria are detailed in protocol
- •1.Patients with active CNS involvement other than PCNSL at study entry are ineligible. Patients with prior CNS disease (leptomeningeal disease or brain metastasis) that has been adequately treated (eg, radiation or intravenous or intrathecal chemotherapy) are permitted, but must have completed such treatment and have no evidence of active CNS disease for at least 4 weeks prior to the first dose of study treatment. Intrathecal chemoprophylaxis to prevent the emergence or recurrence of lymphoma in the CNS is permitted on study during dose expansion only and may be administered per institutional guidelines.
- •2.Radiotherapy delivered to non-target lesions involving > 25% of bone marrow within 1 week prior to starting study treatment or delivered to target lesions that will be followed on the study (NOTE: prior sites of radiation will be recorded)
- •3.Exclusion criterion 3 was deleted as of protocol v5.0 (retained here to preserve numbering).
- •4.Any prior systemic anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc, received within 14 days prior to start of study treatment (with the exception of ibrutinib for Parts A2 and B, which may be continued as part of this study without interruption)
- •5.Current or planned glucocorticoid therapy, with the following exceptions:
- •a.Doses <= 10 mg/day prednisolone or equivalent is allowed, provided that the steroid dose has been stable or tapering for at least 14 days prior to the first dose of study treatment.
- •b.Inhaled, intranasal, intra-articular, and topical steroids are permitted.
- •6.Use of any investigational agent within 21 days or 5 half-lives, whichever is shorter, prior to start of study treatment
- •7.Presence of an acute or chronic toxicity resulting from prior anticancer therapy, with the exception of alopecia, that has not resolved to Grade <= 1, as determined by NCI CTCAE v4.03, within 7 days prior to start of study treatment unless approved by the Medical Monitor
- •8.Known allergy or hypersensitivity to any component of the formulation of CA-4948 (or ibrutinib for entry into Parts A2 or B) used in this study
- •9.Major surgery, other than diagnostic surgery, < 28 days from the start of study treatment; minor surgery < 14 days from the start of study treatment
- •NOTE: Insertion of a vascular access device is not considered minor surgery.
- •10.Known to be human immunodeficiency virus positive or have an acquired immunodeficiency syndrome-related illness
- •11.Hepatitis B virus (HBV) DNA positive or hepatitis C virus (HCV) infection < 6 months prior to start of study treatment unless viral load is undetectable, or HCV with cirrhosis (NOTE: testing required only in patients with history of HBV or history of HCV < 6 months prior to start of study treatment)
- •12.In patients with a history of HBV, hepatitis B core antibody testing is required and if positive, then hepatitis B DNA testing will be performed and if positive the patient will be excluded.
- •13.Uncontrolled or severe cardiovascular disease, including myocardial infarction, unstable angina, or atrial fibrillation within 6 months prior to the start of study treatment; New York Heart Association Class II or greater congestive heart failure; serious arrhythmias requiring medication for treatment; clinically significant pericardial disease; cardiac amyloidosis; or QTc with Fridericia's correction (QTcF) that is unmeasurable or >= 480 msec on Screening ECG. NOTE: For QTcF >= 480 msec on the
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