This is a research study of an experimental drug called ACC-1898. ACC-1898 is an oral tyrosine kinase inhibitor (TKI) that blocks several proteins kinases which may help cancer cells grow and spread.
The purpose of this Phase 1 clinical trial is to find a safe dose of ACC-1898 and to understand how the body absorbs, distributes, and eliminates the drug (pharmacokinetics / PK). The study will also look for early signs that ACC-1898 may slow or shrink tumors and explore possible biological markers related to drug activity.
Adults with advanced or metastatic solid tumors who have no remaining standard treatment options may take part.
All participants will receive ACC-1898 tablets by mouth once daily in repeating 21-day cycles. Treatment may continue for up to two years if the cancer does not worsen and side effects are manageable.
Safety information, laboratory results and imaging scans (CT or MRI) will be collected regularly.
The study will first test different dose levels (dose-escalation phase) and may later expand enrollment in selected tumor types once a recommended dose is found.
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Sequential
ACC-1898
DrugACC-1898 is an oral small-molecule tyrosine kinase inhibitor (TKI). Administered once daily by mouth in continuous 21-day cycles. Starting doses range from 80 mg to 300 mg QD, with possible intra-patient dose modifications. Arm(s)/Group(s): * Arm 1 - ACC-1898 Monotherapy * Arm 2 - ACC-1898 Monotherapy Route of Administration: Oral (tablet) Dose Form: Film-coated tablet (20 mg and 40 mg strengths) Treatment Duration: Up to 2 years or until disease progression or unacceptable toxicity.
Incidence of Dose-Limiting Toxicities (DLTs) Part 1 (Dose Escalation)
Occurrence of DLTs within the first treatment cycle to determine the maximum tolerated dose (MTD) and/or recommended Part 2 dose (OBD).
Treatment-Emergent Adverse Events (TEAEs)
Incidence, severity, and relationship of TEAEs graded per CTCAE v5.0.
Maximum Observed Plasma Concentration (Cmax) Part 1 (Pharmacokinetics)
Maximum plasma concentration after oral dosing, derived from individual plasma concentration-time profiles.
Area Under the Concentration-Time Curve (AUC₀-last) Part 1 (Pharmacokinetics)
Total drug exposure from dosing to last measurable concentration.
AUC₀-τ (steady-state interval) Part 1 (Pharmacokinetics)
Exposure during one 24-hour dosing interval at steady state
AUC₀-∞ Part 1 (Pharmacokinetics)
Total systemic exposure extrapolated to infinity after a single dose.
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This trial is not recruiting at the moment. You can still explore other options:
