A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbisko Therapeutics Co, Ltd
About this trial
This is a multicenter, open-label phase 2 study that will enroll KRASG12C mutated patients with locally advanced or metastatic NSCLC, receiving treatment (ABSK043 in combination with Glecirasib) in a 21-day combination cycle.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Prior to any protocol- specific procedures are performed, the patient should understand and voluntarily sign and date the written informed consent form.
Gender was not limited patients aged ≥18 years at the time of signing the informed consent.
Histologically or cytologically confirmed locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC).
Prior treatment requirements for patients in cohort (Part B) are the same as those for patients in (Part A);
Disqualifiers
Histological or cytological evidence of small cell lung cancer or neuroendocrine carcinoma components.
Toxicities from prior antitumor therapy have not returned to baseline or stabilized.
Patients with active brain metastases.
The patient currently has active interstitial lung disease.
Trial design
Design model
Single group
Treatments tested in this trial
ABSK043 in combination with Glecirasib
DrugDose escalation cohort( Part A) ABSK043 150 mg BID in combination with Glecirasib 200 mg QD will be selected as the starting dose. Based on the accumulated safety data and PK profile, the Safety Review Committee (SRC), composed of the investigator and the sponsor, may discuss and agree to allow exploration of other possible doses. Dose confirmation cohort (Part B) and Expansion cohort Patients in dose confirmation cohort and expansion cohort will receive the recommended dose in dose escalation cohort and be evaluated for safety and preliminary anti-tumor activity. All patients will continue to receive combination therapy every 21 days until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator decision to discontinue treatment, or end of the study.
Treatment groups
86 Participants
are divided into 1 treatment groupGroup A: Experimental: ABSK043 in combination with GlecirasibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of DLT
Dose-limiting toxicities
Time frame
At the end of Cycle 1 (each cycle is 21 days)2
AEs
Adverse events
Time frame
From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months.3
SAEs
Serious adverse events (SAEs)
Time frame
From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months.4
AESIs AESIs
Adverse events of special interest (AESIs)
Time frame
From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months.Secondary outcomes
1
Cmax
Maximum observed concentration
Time frame
From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months2
AUC
area under the concentration-time curve
Time frame
From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.3
t1/2 t1/2
elimination half-life
Time frame
From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.4
Vz/F
apparent volume of distribution
Time frame
From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.Sponsors and contacts
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Source ClinicalTrials.gov