A Phase I Study of ABSK211 in Participants With Advanced Solid Tumors With KRAS Alteration
ConditionSolid Tumor (Phase I)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbisko Therapeutics Co, Ltd
About this trial
This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants should understand, sign, and date the written informed consent form prior to screening.
Male or female age 18 years or older
Participants with histologically confirmed locally-advanced or metastatic solid tumors harboring KRAS alteration
ECOG performance status 0 or 1
Disqualifiers
Known allergy or hypersensitivity to any component of the investigational product
Participants who were previously treated with any inhibitors targeting specific KRAS alleles, pan-KRAS inhibitors, pan- or multi-RAS inhibitors, or any other treatments directly targeting RAS.
Has a known additional malignancy that is progressing or has required active treatment
Has swallowing dysfunction or malabsorption syndrome
Trial design
Design model
Sequential
Treatments tested in this trial
ABSK211
DrugDuring the escalation part ,all participants will firstly receive a single dose of ABSK211 as a run-in period to access the safety and PK of ABSK211. Then, participants will continuously receive ABSK211 once daily (QD), with each treatment cycle of 21 days； In the expansion part，participants will orally receive ABSK211 at the recommended dose for expansion (RDE).
Treatment groups
247 Participants
are divided into 1 treatment groupGroup A: ABSK211Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of DLTs
dose-limiting toxicities
Time frame
from Run-in to Day212
AEs
Adverse events
Time frame
The date of signing the informed consent form until 30 days (including Day 30) after the last administration of investigational product3
SAEs
Serious adverse events (SAEs)
Time frame
The date of signing the informed consent form until 30 days (including Day 30) after the last administration of investigational productSecondary outcomes
1
Cmax
maximum observed concentration
Time frame
from pre-dose to up to 72 hours post-dose2
Tmax
time to maximum observed concentration
Time frame
from pre-dose to up to 72 hours post-dose3
AUC
area under the concentration-time curve
Time frame
from pre-dose to up to 72 hours post-dose4
t1/2
elimination half-life
Time frame
from pre-dose to up to 72 hours post-doseSponsors and contacts
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Source ClinicalTrials.gov