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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
ABSK021
DrugABSK021 oral capsule
Treatment groups
276 Participants
are divided into 1 treatment groupGroup A: ABSK021Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of DLTs
DLT(dose-limiting toxicity)
Time frame
At the end of Cycle 1 (each cycle is 28 days)2
Incidence and Severity of AEs
Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
Time frame
Through study completion, an average of 6 monthsSecondary outcomes
1
PFS
Progression-Free Survival (PFS)
Time frame
From date of enrollment until the date of first documented progression or death, assessed up to 12 months2
DoR
Duration of Response (DoR)
Time frame
From date of enrollment until the date of first documented progression or death, assessed up to 12 months3
DCR
Disease Control Rate (DCR)
Time frame
24 weeks post-dose4
Cmax
The peak plasma concentration of a drug after administration
Time frame
Pre-dose and multiple timepoints (up to 72 hours) post-doseSponsors and contacts
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Source ClinicalTrials.gov