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 range18 Years
SexALL
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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:
✓. ECOG performance score of 0 or 1, or Karnofsky performance score of ≥ 70.
✕. 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.