Who is sponsoring NCT04282044?

NCT04282044 is sponsored by BioEclipse Therapeutics.

What condition does NCT04282044 study?

NCT04282044 studies Solid Tumor, Adult, Triple Negative Breast Cancer, Colorectal Cancer, Hepatocellular Carcinoma, Osteosarcoma, Epithelial Ovarian Cancer, Gastric Cancer, Non-small Cell Lung Cancer, Malignant Melanoma.

What drugs are being tested in NCT04282044?

Interventions: CRX100 suspension for infusion, Fludarabine, Cyclophosphamide.

What is the status of NCT04282044?

NCT04282044 is currently RECRUITING.

Last reviewed 2024-02-07 · How we verify

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

NCT04282044 Phase 1 RECRUITING

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.

Details

Lead sponsor	BioEclipse Therapeutics
Phase	Phase 1
Status	RECRUITING
Enrolment	60
Start date	2021-01-08
Completion	2026-10

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

CRX100 suspension for infusion
Fludarabine
Cyclophosphamide

Primary outcomes

Frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities — 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 investigational drug in monotherapy and investigational drug with combination therapy.
Determine the maximum tolerated dose (MTD), maximum feasible dose (MFD) or optimal biological dose (OBD) and determine recommended Phase 1b/Phase 2a dose level. — 28 days following dose administration for each dosed subject.
Review of safety review committee following subject treatment to review any AEs, SAEs, or DLTs

Countries

United States