search
Back to results

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
Apros Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Colorectal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 16, 2020
Last Updated
January 31, 2023
Sponsor
Apros Therapeutics, Inc
search

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

We'll reach out to this number within 24 hrs