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

Sponsor

Apros Therapeutics, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04645797

Collaborator

(none)

Enrollment

Locations

Arm

34.3

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

Phase 1 Dose EscalationPhase 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 :

Jan 20, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

Primary Outcome Measure [Up to one year]
Determine Maximum Tolerated Dose and/or Recommended Dose within the test APR003 dose range

Secondary Outcome Measures

Secondary Outcome [Up to three years]
Overall Response Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AdventHealth Orlando	Orlando	Florida	United States	32803
2	Carolina BioOncology Institute Cancer Research Clinic	Huntersville	North Carolina	United States	28078
3	NEXT Oncology - Austin	Austin	Texas	United States	78758
4	NEXT Oncology - San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Apros Therapeutics, Inc

Investigators

Study Director: Aaron Weitzman, MD, Apros Therapeutics, Inc
Study Director: Trinh Le, Apros Therapeutics, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Apros Therapeutics, Inc

ClinicalTrials.gov Identifier:

NCT04645797

Other Study ID Numbers:

APR003-001

First Posted:

Nov 27, 2020

Last Update Posted:

May 3, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of May 3, 2021