A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignan… (NCT04645797) | Clinical Trial Compass
TerminatedPhase 1
A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
Stopped: Study terminated prematurely due to internal corporate decision
United States11 participantsStarted 2021-01-19
Plain-language summary
A Phase 1 dose escalation study to evaluate APR003 in patients with advanced colorectal cancer (CRC) with malignant liver lesions
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the Number of Patients With Dose Limiting Toxicities (DLTs)
Timeframe: Until disease progression, or up to approximately 15 months and 18 days, whichever is first
2
Maximum Concentration (Cmax) of APR003
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
3
Time-to-maximum Concentration (Tmax) of APR003
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
4
Area Under the Curve (AUC) From Time Zero to 24 hr (AUC0-24) of APR003
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15 (Cycle duration is 21 days)
5
AUC From Time Zero to Time Infinity (AUC0-ꝏ) of APR003
Timeframe: Cycle 1 Day 1 (Cycle duration is 21 days)
6
AUC Over the Dosing Interval (AUClast) of APR003
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)