Safety and Effectiveness of ABM-168 in Adults with Advanced Solid Tumors. (NCT05831995) | Clinical Trial Compass
TerminatedPhase 1
Safety and Effectiveness of ABM-168 in Adults with Advanced Solid Tumors.
Stopped: Due to development strategy change.
United States12 participantsStarted 2023-03-30
Plain-language summary
This is a Phase 1, First-in-Human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ABM-168 in adult patients with RAS or RAF or NF-1 mutated advanced solid tumors as ABM-168 may have a significant effect in inhibiting cell growth.
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
. Male and female subjects age 18 years and older who are able to sign informed consent and comply with the protocol
. Patients with histologically or cytologically documented, locally advanced, or metastatic solid tumor malignancy that has either:
. failed prior standard therapy; or
. exhausted all existing standard therapy; or
. standard therapy is not considered appropriate per subject and/or investigator. No limitation on the lines of previous standard therapy received.
. Patients with asymptomatic or symptomatic but stable brain metastases or CNS primary malignancies who meet following criteria specifically:
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.
. ECOG performance score of 0 or 1, or Karnofsky performance score of ≥ 70.
. ≥ 3 months life expectancy
Exclusion criteria
. Women who are pregnant or breast-feeding.
. Have leptomeningeal disease (LMD).
. Have a history of stroke within 6 months prior to the first dose.
. Have impaired cardiac function or clinically significant cardiovascular disease(s) including but not limited to any of the following:
. Have uncontrolled hypertension at screening, with systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg after receiving anti-hypertension treatment.
. Have unresolved ≥ CTCAE Grade 2 diarrhea at the time of the first dose; or have gastrointestinal impairment conditions or diseases that significantly alter ABM-168 absorption at screening per investigator (e.g., ulcerative disease, poorly controlled nausea, vomiting, malabsorption syndrome, or small intestine dissection)
. Have ≥ CTCAE Grade 2 eye diseases at screening, such as conjunctival mixed cellular inflammation, corneal ulcer.
. Have severe chronic or active infection requiring intravenous antibiotic treatment(s) within 2 weeks prior to the first dose, including but not limited to hospitalization due to infection complications, bacteremia, severe pneumonia or active tuberculosis.