NCT04282044

Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: BioEclipse Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor, Adult
• Triple Negative Breast Cancer
• Colorectal Cancer
• Hepatocellular Carcinoma
• Osteosarcoma
• Epithelial Ovarian Cancer
• Gastric Cancer
• Non-small Cell Lung Cancer
• Malignant Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	CRX100 suspension for infusion	A fixed dose of CIK cells combined with the specified dose of CDSR.
COMBINATION_PRODUCT	Fludarabine	25mg/m IV (five doses given from Day -7 until Day -3)
COMBINATION_PRODUCT	Cyclophosphamide	60mg/kg intravenous (IV) (two doses given on Day -7 and -6)

Timeline

• Start date: 2021-01-08
• Primary completion: 2025-08-01
• Completion: 2026-10-01
• First posted: 2020-02-24
• Last updated: 2024-02-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study