A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions

Stopped early · Phase 1

Conditions studied: Advanced Colorectal Carcinoma

In brief

A Phase 1 dose escalation study to evaluate APR003 in patients with advanced colorectal cancer (CRC) with malignant liver lesions

Key facts

Study ID

NCT04645797

Run by

Apros Therapeutics, Inc

People needed

11

Starts

2021-01-19

Expected to finish

2022-05-07

Last updated by the study team

2025-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status of 0 or 1
• Must have disease that is considered non-surgically resectable.
• Relapsed or persistent/refractory to at least two prior systemic treatment regimens for locally advanced or metastatic disease considered to be standard-of-care (SOC).
• Must have previously received an irinotecan or oxaliplatin-based therapy, as well as a targeted antibody therapy for metastatic disease
• Tumors that are MSI-H/dMMR must have previously received checkpoint inhibitor therapy
• Adequate hepatic function
• Adequate renal function
• Normal coagulation panel
• Willingness to use effective contraception

You may not qualify if…

• Current or history of CNS metastases
• Significant cardiovascular disease
• Pregnant or breastfeeding

Where it is running

• AdventHealth Orlando — Orlando, Florida, United States
• Carolina BioOncology Institute Cancer Research Clinic — Huntersville, North Carolina, United States
• NEXT Oncology - Austin — Austin, Texas, United States
• NEXT Oncology - San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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