CTIS2023-508002-20-00招募中1 期
A Phase 1/2 Study of CPI-0209 in Patients with Advanced Solid Tumors and Lymphomas - 0209-01
Constellation Pharmaceuticals Inc.0 个研究点目标入组 210 人开始时间: 2024年3月11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
- 210
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Adult (aged = 18 years), Male and female patients and their partners with childbearing potential should agree to use at least one of the highly effective contraceptive methods listed in Section 6.12.1.1 while on study therapy and for 93 days after the last dose of CPI0209 for male patients and male partners of female patients, and for 183 days- after the last dose of CPI-0209 for female patients and female partners of male patients. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year., Signed and dated institutional review board (IRB)/independent ethics committee (IEC) approved informed consent form (ICF) before any protocol-directed screening procedures are performed., P1:adults with confirmed locally advanced or metastatic tumors (solid tumors or lymphoma) who have relapsed after or progressed through standard therapy or who have a disease with no standard effective therapy P2, M1: adults with UC or other advanced/metastatic solid tumors, except COCC, and endometrial carcinoma EC: Only for UC: a Confirmed, locally advanced, unresectable or metastatic UC with predominant urothelial histology b Known ARID1A mutation c If eligible for PCC, must have PD during or following prior PCC, should have received prior PD1 or PD-L1 therapy. Pts unfit for cisplatin must have previously received carboplatin combination (and prior anti-PD1 or anti-PD-L1 therapy, as per local clinical practice). d If not eligible for PCC, must have PD during or following prior anti-PD1 or anti-PD-L1 therapy e Measurable disease per RECIST1.1 Only for other metastatic solid tumors: a Confirmed metastatic solid tumor with known ARID1A mutation (except COCC, EC, pleural or peritoneal mesothelioma) b Known ARID1A mutation c Pt must have PD following approved therapies or for which no standard therapy exists (all countries), all available therapies have failed, and no therapies known to provide clinical benefit are available (FR only) d Measurable disease per RECIST1.1 P2 pts, M2:adults with CCOC: a Confirmed advanced CCOC b ARID1A mutation c Must have received min.1 line of PCC and bevacizumab d Measurable disease per RECIST1.1 e Pt must have PD after receiving effective and available SoC treatment for CCOC P2 pts, M3:adults with EC: a Confirmed recurrent, metastatic, or unresectable EC b Known ARID1A mutation c Min.1 line of PCC in recurrent/metastatic setting d Pts with documented MSI-high or, dMMR or non-dMMR/microsatellite stable tumors should have received prior anti-PD-1 or anti-PD-L1 therapy e Brachytherapy is allowed if completed >12wks before 1st dose of study drug f Measurable disease per RECIST1.1 g Pt must have received effective and available SoC treatment for EC. Pts with operable metastases in first relapse are not eligible and must undergo surgery; such pts are eligible with min.4wks between surgery and 1st dose of study drug and recovery from any effects of the surgery. P2 pts, M4: adults with lymphoma: a Confirmed PTCL or DLBCL with following criteria: PTCL: Documented refractory, relapsed, or PD after min.1 prior line of systemic therapy. Must have min.1 prior line of systemic therapy for PTCL o Pts must be considered HCT ineligible during screening due to disease status (active disease), comorbidities, other factors o In PTCL cohort, pts with ALCL must have prior brentuximab vedotin treatment DLBCL: Relapsed/refractory disease following 2 or more prior lines of SoC therapy
排除标准
- •Previous solid organ or allogeneic HCT., Clinically active or symptomatic viral hepatitis or chronic liver disease., Unstable or severe uncontrolled medical condition or any important medical or psychiatric illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study., Known symptomatic untreated brain metastases. Patients with CNS metastases must have stable neurologic status following local therapy for at least 4 weeks on stable or decreasing dose of steroid = 10 mg daily prednisone (or equivalent). Patients in the M4 lymphoma cohort will not be eligible if they have known CNS involvement by lymphoma., Clinically significant cardiovascular disease including: a. Myocardial infarction/stroke within 3 months prior to Day 1 of treatment. b. Unstable angina within 3 months prior to Day 1 of treatment. c. Congestive heart failure or cardiomyopathy with New York Heart Association (NYHA; see APPENDIX 3) Class 3 or 4. d. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes). e. Uncontrolled hypertension (as defined per institutional standards) despite 2 concomitant antihypertensive therapies. f. QT interval corrected by the Fridericia correction formula (QTcF) = 480 msec on the Screening ECG., Major surgery within 4 weeks before starting study drug or not recovered from any effects of prior major surgery (uncomplicated central line placement or fine needle aspirate are not considered major surgery)., Gastrointestinal disorders, ie, ulcerative colitis, malabsorption syndrome, refractory nausea and vomiting, biliary shunt, significant bowel resection, or any other condition that may significantly interfere with absorption of the study medication by Investigator’s assessment., Uncontrolled active infection requiring intravenous antibiotic, antiviral, or antifungal medications within 14 days before the first dose of study drug. Infections (eg, urinary tract infection) controlled on concurrent antimicrobial agents and antimicrobial prophylaxis per institutional guidelines are acceptable., Suspected pneumonitis or interstitial lung disease (confirmed by radiography or CT) or a history of pneumonitis or interstitial lung disease., Have a history of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for = 1 year prior to randomization, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for = 3 years. Patients with a history of T-cell lymphoblastic lymphoma or T-cell lymphoblastic leukemia are not eligible., Have current known active or chronic infection with HIV, hepatitis B, or hepatitis C. Screening of patients with serologic testing for these viruses is not required. However, patients who have a past history of viral hepatitis or in whom there is a current suspicion of viral hepatitis should have serologic testing for hepatitis B and hepatitis C performed to determine whether there is any current evidence for ongoing infection with these viruses. Patients considered to be at risk for HIV i
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