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

Advanced Colorectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645797
• Other study ID #: APR003-001
• Status: Completed
• Phase: Phase 1
• Start date: January 20, 2021
• Est. completion date: January 9, 2023

Study information

• Verified date: January 2021
• Source: Apros Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	NEXT Oncology - Austin	Austin	Texas
United States	Carolina BioOncology Institute Cancer Research Clinic	Huntersville	North Carolina
United States	AdventHealth Orlando	Orlando	Florida
United States	NEXT Oncology - San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Apros Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure	Determine Maximum Tolerated Dose and/or Recommended Dose within the test APR003 dose range	Up to one year
Secondary	Secondary Outcome	Overall Response Rate	Up to three years