A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors (NCT06399757) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
United States100 participantsStarted 2024-06-18
Plain-language summary
This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 for the treatment of selected locally advanced or metastatic solid tumors with particular focus on Colorectal carcinoma (CRC).
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.
Exclusion criteria
. Aspartate aminotransferase and/or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) (\>5 x ULN for subjects with liver metastases)
. Total bilirubin \>1.5 × ULN (except participants with Gilbert's syndrome).
. Albumin \< 3 g/dL
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
Incidence of Treatment Emergent Adverse Events [Safety]
Timeframe: Through study completion, approximately one year
2
Incidence of dose limiting toxicities [Tolerability] (Phase 1)
Timeframe: Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days)
3
Determine Recommended Phase 2 Dose (RP2D) levels of APL-5125 in participants with selected advanced solid tumors (Phase 1)
Timeframe: Approximately one year
4
Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)
Timeframe: Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)