Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stabl… (NCT05167409) | Clinical Trial Compass
TerminatedPhase 2
Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer
Stopped: Accrual was terminated due to safety concerns
United States19 participantsStarted 2022-07-28
Plain-language summary
This Phase 2 clinical study will evaluate evorpacept (ALX148) in combination with cetuximab and pembrolizumab for refractory microsatellite stable metastatic colorectal cancer
Who can participate
Age range
18 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
. Provision to sign and date the consent form.
. Able to comply with all study procedures and be available for the duration of the study in the Investigator's judgment.
. Age ≥ 18 years on the day of signing informed consent
. If in Cohort A, the patient must state willingness to undergo pre- and post-treatment biopsies. According to the Investigator's judgement, the planned biopsies should not expose the patient to substantially increased risk of complications.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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
Objective Response Rate (ORR)
Timeframe: The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)
2
Determine the Recommended Dose (RD) of Evorpacept (ALX148) in Combination With Cetuximab and Pembrolizumab
Timeframe: During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.
. Progression on at least two prior lines of therapy for unresectable metastatic colorectal adenocarcinoma.
Exclusion criteria
. Microsatellite stable or proficient mismatch repair status documented (only one of these criteria is needed, however if one criterion is met and one is not met then the patient is excluded)
. Measurable disease, according to RECIST v1.1. Previously irradiated lesions are not considered measurable unless progression has been documented in the lesion. Note that lesions intended to be biopsied should not be target lesions.
0. Adequate hematologic and end organ function, defined by the following laboratory results:
1. QTcF interval of ≤480 msec (Based upon value from the screening ECG).
2. Serum pregnancy test (for females of childbearing potential) negative at screening and at C1D1. A woman is considered fertile (woman of childbearing potential, "WOCBP") following menarche and until becoming post-menopausal unless permanently sterile. Women in the following categories are not considered WOCBP:
3. For men: Male participants with female partners of childbearing potential are eligible to participate if they agree to one of the following during the treatment period and for at least 180 days after the last dose of study treatment as defined below. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Men must also agree to refrain from donating sperm following during the treatment period and for at least 180 days after the last dose of study treatment.
. Patients with known MSI-high status or known mismatch repair deficiency (dMMR)
. Patients in whom both mismatch repair and microsatellite stability status are unknown