Description:
A Phase 1 dose escalation study to evaluate APR003 in patients with advanced colorectal cancer (CRC) with malignant liver lesions
Clinical Trials /
A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
NCT04645797
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
| Drug | Synonyms | Arms |
|---|---|---|
| APR003 | APR003 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
| Name | Type | Description | Interventions |
|---|---|---|---|
| APR003 Dose Escalation | Experimental | 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. |
|
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
May 3, 2021
