RecruitingPhase 1NCT04282044

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

Sponsor

BioEclipse Therapeutics

Enrollment

60 participants

Start Date

Jan 8, 2021

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new experimental drug called CRX100, alone or combined with the immunotherapy drug pembrolizumab, in patients with advanced solid tumor cancers that have not responded to other treatments. The study is in early stages and is focused on finding the right dose and assessing safety. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of a specific advanced solid tumor type included in the study - Your cancer has progressed or stopped responding to standard therapies - You are willing to undergo study procedures and monitoring **You may NOT be eligible if...** - You are not diagnosed with one of the eligible tumor types - You have serious active infections or autoimmune conditions - You have had severe side effects from prior immunotherapy - Your organ function is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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