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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
ABTL0812. Five cohorts and one extension phase.
Hospital Clínic
Barcelona, Barcelona, Spain
To determine the maximum tolerated dose (MTD) of ABTL0812, administered orally on a daily continuous schedule in adult patients with advanced solid tumours
Time frame: First 28 days of treatment
To assess safety and tolerability of ABTL0812
Time frame: First 28 days of treatment
To evaluate preliminary antitumour activity of ABTL0812
Time frame: After 6 months of treatment
To determine the recommended Phase II dose
Time frame: First 28 days of treatment
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