OncoMatch/Clinical Trials/NCT04282044
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
Is NCT04282044 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CRX100 suspension for infusion and Fludarabine for solid tumor, adult.
Treatment: CRX100 suspension for infusion · Fludarabine · Cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Triple-Negative Breast Cancer
Breast Carcinoma
Colorectal Cancer
Hepatocellular Carcinoma
Osteosarcoma
Ovarian Cancer
Gastric Cancer
Non-Small Cell Lung Carcinoma
Melanoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — relapsed or refractory ovarian cancer
Subjects with Ovarian cancer must have received at least one prior standard of care for their relapsed or refractory disease, which must include a platinum-based regimen
Cannot have received: chemotherapy
Subjects who received any chemotherapy ... within three weeks of enrollment
Cannot have received: immunotherapy (non-cell-based therapies)
Subjects who received any ... immunotherapies (non-cell-based therapies) ... within three weeks of enrollment
Cannot have received: oncolytic virus therapy
Subjects who received any ... oncolytic virus therapy ... within three weeks of enrollment
Cannot have received: radiotherapy
Subjects who received any ... radiotherapy ... within three weeks of enrollment
Cannot have received: radiosurgery
Subjects who received any ... radiosurgery ... within three weeks of enrollment
Cannot have received: investigational agents
Subjects who received any ... investigational agents within three weeks of enrollment
Cannot have received: cell-based therapies
Subjects who received any type of cell-based therapies within the last 12 weeks from the planned apheresis date
Lab requirements
Blood counts
ALC >500 cells/mm3, ANC >750 cells/mm3 (LDC cohorts: >1000), hemoglobin >8 g/dL, platelet count >50,000 cells/mm3 (LDC cohorts: >100,000); thresholds must be achieved without transfusion or growth factors within two weeks
Kidney function
serum creatinine <1.5x institutional ULN or calculated creatinine clearance >50 mL/min
Liver function
total bilirubin ≤1.5x institutional ULN; AST and ALT ≤2.5x institutional ULN, unless liver metastases are present, in which case ≤5x ULN; INR ≤1.5. For HCC: total bilirubin ≤3x ULN, AST/ALT ≤5x ULN, INR ≤1.7, Child-Turcotte-Pugh score <8.
Adequate hematologic function ... Adequate organ function, defined as: ... (see above for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- HonorHealth Research Institute · Scottsdale, Arizona
- UC San Diego Moores Cancer Center · La Jolla, California
- Stanford University · Stanford, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify