A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbisko Therapeutics Co, Ltd
About this trial
This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.
Eligibility criteria
Qualifiers
Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists
ECOG (electrocorticogram) performance status 0~1
Life expectancy ≥ 3 months
Adequate organ function and bone marrow function
Disqualifiers
Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colony stimulating factor 1 receptor) pathway inhibitors
Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment
Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication
Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever is shorter) prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment)
Trial design
Treatments tested in this trial
- ABSK021
Treatment groups
276 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov