Trial | NCT04645797  Report issue

Title

A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
A Phase 1 Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics/ Pharmacodynamics of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    APR003

  • Study Participants

    11
A Phase 1 dose escalation study to evaluate APR003 in patients with advanced colorectal cancer (CRC) with malignant liver lesions
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 Started
Jan 20
2021
Primary Completion
Jan 09
2023
Study Completion
Jan 09
2023
Last Update
Feb 01
2023

Drug APR003

This portion of the study further explores the clinical activity, safety, pharmacokinetics and pharmacology of APR003 monotherapy at the RP2D and to assess the antitumor activity of APR003 in subjects with unresectable CRC with liver metastases.

APR003 Dose Escalation Experimental

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.

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
No Results Posted