A first-in-human, phase 1/2, dose escalation study of BOXR1030 T cells in subjects with advanced GPC3-positive solid tumors

SOTIO Biotech Inc0 个研究点目标入组 98 人开始时间: 2022年9月29日最近更新: 2023年6月20日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 98

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Aged 18 to 80 years at time of enrollment
•2. Able to provide a recent tumor specimen taken since the time of the subject’s most recent systemic anticancer therapy, for GPC3 expression assessment by IHC.
•3. Histologically confirmed advanced unresectable or metastatic hepatocellular carcinoma (HCC), squamous cell carcinoma (SCC) of the lung, myxoid/round cell liposarcoma, or MCC with GPC3 overexpression by IHC, with a cytoplasmic/membranous H-score >30 for study eligibility.
•4. Documentation of disease progression or refractory disease or intolerance to prior lines of standard-of-care (SOC) therapies. Patients with tumors with genetic alterations and mutations who have approved targeted therapies available for their cancer will need to have been treated with such approved therapies or refused such approved targeted therapy for their cancer prior to enrolling in this study.
•5. Life expectancy >16 weeks
•6. Have adequate organ/renal function as defined by the protocol
•7. Left ventricular ejection fraction (LVEF) =50% by multiple-gated acquisition (MUGA) scan or echocardiogram (ECHO)
•8. Eastern Cooperative Oncology Group performance status of 0 to 1
•9. For subjects with HCC:
•9.1 Child-Pugh Score of A
•9.2 No fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma histology
•9.3 No moderate or severe ascites
•10. A minimum of 2 sites of disease, including at least 1 site that is measurable by RECIST Version 1.1 criteria to ensure sufficient disease for response assessment. At least 1 of the other lesions must be considered adequate for protocol-required
•tumor biopsy. Consider prioritization of percutaneous lesions that are palpable, or guided by imaging if necessary, and exclude biopsies of any lesions that are in proximity to vital visceral, cardio-pulmonary, or any neurovascular structures. A single site of disease is considered adequate to allow for response assessment and protocol-required tumor biopsies if it measures at least 2 cm in the shortest axis.
•11.1 Adequate wash-out of prior systemic therapy for underlying malignancy, relative to leukapheresis:
•11.1.a Last dose of any antineoplastic treatment must be at least 2 weeks before leukapheresis.
•11.1.b Last dose of any investigational agent must be at least 3 half-lives of the treatment, or 28 days, before leukapheresis (whichever is shorter).
•11.2 Adequate wash-out of prior systemic therapy for underlying malignancy, relative to LD chemotherapy:
•11.2.a The last dose of systemic nitrosourea or systemic mitomycin-C must be at least 6 weeks before the first dose of LD chemotherapy in this study.
•11.2.b For all other for systemic cytotoxic chemotherapy, the wash-out must be the duration of a full cycle of that therapy.
•11.2.c For biologic therapy (eg, antibodies) the wash-out must be either the duration of the biologic agent dosing interval, or 3 weeks, whichever is shorter.
•11.2.d For small molecule therapies, the wash-out must be 5 half-lives of the drug.
•11.2.e For any investigational agent, the wash-out must be 3 half-lives of the investigational agent, or 4 weeks, whichever is shorter.

排除标准

•1. Prior treatment with adoptive cell therapy
•2. History of allogenic hematopoietic stem cell transplant (HSCT).
•3. Untreated central nervous system (CNS) tumors or brain metastasis unless they are asymptomatic, were treated and patients have neurologically returned to baseline. Imaging obtained for the purpose of CNS metastases management performed within 28 days prior to Day 1 must document radiographic stability of CNS lesions and be performed after completion of any CNS directed therapy. CNS evaluation for asymptomatic patients is not required for the study. Patients with leptomeningeal metastases are excluded.
•4. Patients who have not recovered to = Grade 1 or baseline from all AEs due to previous therapies (patients with = Grade 2 neuropathy that has been stable for at least 4 weeks or =Grade 2 endocrine-related AEs that has been stable for at least 4 weeks on replacement therapy).
•5. Planned use of any antineoplastic treatment or investigational agent from the time of the first dose of LD chemotherapy through the end of study participation, except for allowed local radiation of lesions for palliation (to be considered non-target lesions after treatment) and hormone ablation.
•6. Uncontrolled or life-threatening symptomatic concomitant disease including clinically significant gastrointestinal bleeding or pulmonary hemorrhage within 4 weeks before screening, known symptomatic human immunodeficiency virus (HIV) positive with an
•acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count <350 cells/uL, symptomatic active hepatitis B or C checked at screening, or active tuberculosis. Patients with HIV are eligible if:
•6.1 They have received antiretroviral therapy (ART) as clinically indicated for at least 4 weeks prior to starting study treatment
•6.2 They continue on ART as clinically indicated while enrolled on study
•6.3 CD4 counts and viral load are monitored per standard of care by a local health care provider
•7. Has undergone a major surgery within 3 weeks of starting study treatment or has inadequate healing or recovery from complications of surgery prior to starting study treatment.
•8. Has received prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had severe radiation pneumonitis. A 1-week wash-out is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
•9. Potentially life-threatening second malignancy requiring systemic treatment within the last 3 years (ie, patients with a history of prior malignancy are eligible if treatment was completed at least 3 years before entering the Treatment Period and the patient has no evidence of disease) or which would impede evaluation of treatment response. Hormone ablation therapy is allowed within the last 3 years. Patients with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible.
•10. Clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enro

研究者

发起方

SOTIO Biotech Inc

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