Study of CRX100 in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04282044|
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult Triple Negative Breast Cancer Colorectal Cancer Hepatocellular Carcinoma Osteosarcoma Epithelial Ovarian Cancer Gastric Cancer||Biological: CRX100 suspension for infusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Dose-Escalation Study of CRX100 in Patients With Advanced Solid Tumors|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: Dose Escalation
Dose escalation cohort for treatment of solid tumors that are relapsed, refractory or intolerant to standard care, or refusing standard therapies.
Biological: CRX100 suspension for infusion
A fixed dose of CIK cells combined with the specified dose of CDSR.
- Frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities [ Time Frame: 28 days following dose administration for each dosed subject. ]The Primary Outcome Measure will be based on the frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities during and after the administration of a single dose of the investigational drug.
- Biodistribution of CRX100 based on subject's viral load as assessed through a viral shedding assay. [ Time Frame: 28 days following dose administration for each dosed subject. ]To characterize the biodistribution of CRX100 based on each subject's viral load as assessed through a viral shedding assay, following a single dose of investigational product.
- Immune response to investigational drug based on subject's levels of neutralizing antibodies. [ Time Frame: 28 days following dose administration for each dosed subject. ]Levels of neutralizing vvDD antibodies will be summarized by dose level and time point following a single dose of investigational product.
- Early anti-tumor activity of investigational drug based on iRECIST criteria [ Time Frame: 6 months after dose administration for each dosed subject. ]Summarized based on best response observed using RECIST classification of response. Overall response and frequencies of each level of response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282044
|Contact: Leslie Stricklerfirstname.lastname@example.org|