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

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ClinicalTrials.gov Identifier: NCT04645797
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Apros Therapeutics, Inc

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

Condition or disease Intervention/treatment Phase
Advanced Colorectal Carcinoma Drug: APR003 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1 Dose Escalation
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: APR003 Dose Escalation
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Outcome Measure [ Time Frame: Up to one year ]
    Determine Maximum Tolerated Dose and/or Recommended Dose within the test APR003 dose range


Secondary Outcome Measures :
  1. Secondary Outcome [ Time Frame: Up to three years ]
    Overall Response Rate


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645797


Contacts
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Contact: There may be multiple sites in this clinical trial. 858-345-6638 clinical@aprostx.com

Locations
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United States, Florida
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Elizabeth Griffith    407-303-2800 ext 1101783    elizabeth.griffith@adventhealth.com   
United States, North Carolina
Carolina BioOncology Institute Cancer Research Clinic Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Jaelyn Linski    980-441-1015    jlinkski@carolinabiooncology.org   
United States, Texas
NEXT Oncology - Austin Recruiting
Austin, Texas, United States, 78758
Contact: Cynthia Deleon    210-580-9521    cdeleon@nextoncology.com   
NEXT Oncology - San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Cynthia Deleon    210-580-9521    cdeleon@nextoncology.com   
Sponsors and Collaborators
Apros Therapeutics, Inc
Investigators
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Study Director: Aaron Weitzman, MD Apros Therapeutics, Inc
Study Director: Trinh Le Apros Therapeutics, Inc
More Information
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Responsible Party: Apros Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT04645797    
Other Study ID Numbers: APR003-001
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases