Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Sandip Patel, MD (ucsd)
Headshot of Sandip Patel
Sandip Patel

Description

Summary

This clinical study is an open-label, Phase 1, dose-escalation study to determine the safety, tolerability, and efficacy of the drug product produced by Administering CRX100 alone and in combination with Pembrolizumab in advanced solid malignancies. Patients will be screened and evaluated to determine whether or not they meet stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo generation of CRX100. Patients with non-small cell lung cancer (NSCLC), ovarian cancer, colorectal cancer, hepatocellular carcinoma (HCC), malignant melanoma (excluding uveal melanoma), gastric cancer, triple negative breast cancer, and osteosarcoma.

The study will start with monotherapy dose escalation followed by combination cohorts.

Official Title

A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid Malignancies

Keywords

Solid Tumor, Adult, Triple Negative Breast Cancer, Colorectal Cancer, Hepatocellular Carcinoma, Osteosarcoma, Epithelial Ovarian Cancer, Gastric Cancer, Non-small Cell Lung Cancer, Malignant Melanoma, Melanoma, Triple Negative Breast Neoplasms, Ovarian Epithelial Carcinoma, Cyclophosphamide, Fludarabine, CRX100 suspension for infusion

Eligibility

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States
  • HonorHealth Research Institute accepting new patients
    Scottsdale Arizona 85258 United States

Lead Scientist at University of California Health

  • Sandip Patel, MD (ucsd)
    Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 70 research publications. Research interests: cancer immunotherapy · phase 1 clinical trials · cellular therapy · microbiome · thoracic oncology · NSCLC · immune related adverse events · spatial biology · cancer informatics · wearables and toxicity monitoring

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BioEclipse Therapeutics
ID
NCT04282044
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated