A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
Primary Purpose
Advanced Colorectal Carcinoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
APR003
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Colorectal Carcinoma
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
Sites / Locations
- AdventHealth Orlando
- Carolina BioOncology Institute Cancer Research Clinic
- NEXT Oncology - Austin
- NEXT Oncology - San Antonio
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
APR003 Dose Escalation
Arm Description
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.
Outcomes
Primary Outcome Measures
Primary Outcome Measure
Determine Maximum Tolerated Dose and/or Recommended Dose within the test APR003 dose range
Secondary Outcome Measures
Secondary Outcome
Overall Response Rate
Full Information
NCT ID
NCT04645797
First Posted
September 16, 2020
Last Updated
January 31, 2023
Sponsor
Apros Therapeutics, Inc
1. Study Identification
Unique Protocol Identification Number
NCT04645797
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
January 9, 2023 (Actual)
Study Completion Date
January 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apros Therapeutics, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Phase 1 Dose Escalation
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APR003 Dose Escalation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
APR003
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Outcome Measure
Description
Determine Maximum Tolerated Dose and/or Recommended Dose within the test APR003 dose range
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Secondary Outcome
Description
Overall Response Rate
Time Frame
Up to three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Weitzman, MD
Organizational Affiliation
Apros Therapeutics, Inc
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trinh Le
Organizational Affiliation
Apros Therapeutics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Carolina BioOncology Institute Cancer Research Clinic
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
NEXT Oncology - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
NEXT Oncology - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
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