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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apros Therapeutics, Inc

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Current or history of CNS metastases

• Significant cardiovascular disease

• Pregnant or breastfeeding