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 sites98 target enrollmentSeptember 29, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: SOTIO Biotech Inc
Enrollment: 98
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 29, 2022

End Date

December 23, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

SOTIO Biotech Inc

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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