CRX100 suspension for infusion for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Colorectal Cancer+6 MoreCRX100 suspension for infusion - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective. The drug will be given to patients with different types of cancer to see if it shrinks their tumors.

Eligible Conditions
  • Colorectal Cancer
  • Osteosarcoma
  • Liver Cancer
  • Stomach Cancer
  • Ovarian Cancer
  • Solid Tumors, Adult
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 6 months after dose administration for each dosed subject.

Day 28
Biodistribution of CRX100 based on subject's viral load as assessed through a viral shedding assay.
Frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities
Immune response to investigational drug based on subject's levels of neutralizing antibodies.
Month 6
Early anti-tumor activity of investigational drug based on iRECIST criteria

Trial Safety

Safety Progress

1 of 3

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Trial Design

1 Treatment Group

Dose Escalation
1 of 1

Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: CRX100 suspension for infusion · No Placebo Group · Phase 1

Dose Escalation
Biological
Experimental Group · 1 Intervention: CRX100 suspension for infusion · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months after dose administration for each dosed subject.

Who is running the clinical trial?

BioEclipse TherapeuticsLead Sponsor
Oliver Dorigo, MDPrincipal InvestigatorStanford University

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must have a histologically confirmed diagnosis of one of the following tumors in order to be eligible: triple negative adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, or gastric cancer
The patient's hematologic function must be adequate at the time of screening, meaning that their absolute lymphocyte count must be greater than 500 cells/mm3, their absolute neutrophil count must be greater than 750 cells/mm3, their hemoglobin must be greater than 8 g/dL, and their platelet count must be greater than 50,000 cells/mm3
People must have recovered from the effects of recent surgery, radiation therapy, or chemotherapy in order to participate in the study.
You must be at least 18 years old to give consent.
I consent to participate in this study, and voluntariness and understanding has been obtained from me
People who have relapsed disease, are refractory or intolerant to standard care, or refusing standard therapies, may be good candidates for this study.
Subjects must have measurable disease using CT or MRI with IV contrast, with at least one measurable target lesion.
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Subjects must not be taking antibiotics, antifungals, or antiviral medications, unless they are receiving treatment doses.
Do not give any cellular therapies for at least 12 weeks before apheresis.