Cancer Clinical Trial
Official title:
A PHASE I/Ib, FIRST IN HUMAN, DOSE-ESCALATION STUDY OF ABTL0812 IN PATIENTS WITH ADVANCED SOLID TUMOURS
Ability Pharmaceuticals promotes a clinical trial to determine the adequate dose of a new drug, ABTL0812, that will be administered orally daily to patients with advanced solid tumors.
This is a phase I/Ib, unicenter, open-label and single-agent study. This study consists of
two different parts, a dose escalation phase and an extension phase in patients with
advanced solid tumors.
ABTL0812 will be administered orally, daily, for 28 days (considered cycle 1). First
endpoint is to determine the Maximum Tolerated Dose (MTD). MTD is defined as the highest
dose at which no more than one in six patients experiences a ABTL0812 related Dose-Limiting
Toxicity (DLT). DLT will be evaluated during the first treatment cycle.
Dose escalation phase will be performed with an accelerated design of 3 + 3
Once the 28 days cycle has finished, patients may continue receiving ABTL0812 on a daily
continuous schedule if the patient is deemed to have clinical benefit from treatment,
according to the treating physician. Treatment will continue until disease progression,
onset of unacceptable drug toxicities, or patient/physician's request to discontinue.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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