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

Phase 1

Completed

• Conditions: Advanced Colorectal Carcinoma
• Interventions: Drug: APR003

• Registration Number: NCT04645797
• Lead Sponsor: Apros Therapeutics, Inc

Brief Summary

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

Detailed Description

APR003 is a small molecule TLR7 agonist that concentrates in the GI, and liver with limited systemic exposure. It is designed to increase the therapeutic window of a TLR7 agonist by minimizing the side-effects associated with generalized systemic immune activation and inflammation.

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-11-22
• Study First Posted: 2020-11-27
• Status Verified: 2021-01
• Study Start: 2021-01-20
• Primary Completion: 2023-01-09
• Study Completion: 2023-01-09
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
APR003 Dose Escalation	APR003	This portion of the study will evaluate the safety and pharmacokinetics of a range of APR003 doses administered once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure	Up to one year	Determine Maximum Tolerated Dose and/or Recommended Dose within the test APR003 dose range

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome	Up to three years	Overall Response Rate

Trial Locations

Locations (4)

NEXT Oncology - San Antonio; 🇺🇸 San Antonio, Texas, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

NEXT Oncology - Austin; 🇺🇸 Austin, Texas, United States

Carolina BioOncology Institute Cancer Research Clinic; 🇺🇸 Huntersville, North Carolina, United States