Clinical Trials /

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

NCT04645797

Description:

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

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
  • 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 IDs

  • ORG STUDY ID: APR003-001
  • NCT ID: NCT04645797

Conditions

  • Advanced Colorectal Carcinoma

Interventions

DrugSynonymsArms
APR003APR003 Dose Escalation

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
APR003 Dose EscalationExperimentalThis 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.
  • APR003

Eligibility 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
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Primary Outcome Measure
Time Frame:Up to one year
Safety Issue:
Description:Determine Maximum Tolerated Dose and/or Recommended Dose within the test APR003 dose range

Secondary Outcome Measures

Measure:Secondary Outcome
Time Frame:Up to three years
Safety Issue:
Description:Overall Response Rate

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Apros Therapeutics, Inc

Last Updated

January 25, 2021