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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer

ConditionNon-Small Cell Lung Cancer
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, non-randomized, openlabel, phase 1 study of ABSK112 in patients with NSCLC to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients should understand, sign, and date the written informed consent form prior to screening.

Male or female aged 18 years or older.

Patients with histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC.

For the escalation part (except for the RDE confirmation part), patients have progressed on, rejected, or are intolerant of standard therapy, or for whom no standard therapy exists

Disqualifiers

Known allergy or hypersensitivity to any component of the investigational product.

NSCLC patients with EGFR Cys797Ser (C797S) mutation.

Cohort-specific exclusion criteria.

Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ABSK112

    Drug

    In the escalation part, patients will receive a single dose of oral ABSK112 on Cycle1 Day1 only, and then patients will continuously receive ABSK112 once daily (QD) or twice daily (BID) in subsequent cycles. In the expansion part, patients will each be treated at the selected RDE dose level.

Treatment groups

164 Participants
are divided into 1 treatment group
Group A: ABSK112Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of DLT

Dose-limiting toxicities

Time frame
from Day1 to Day28
2

AEs

Adverse events

Time frame
The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 50 months.
3

AESIs

Adverse events of special interest (AESIs)

Time frame
The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 50 months.
4

SAEs

Serious adverse events (SAEs)

Time frame
The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 50 months.

Secondary outcomes

1

Cmax

Maximum observed concentration

Time frame
From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
2

AUC

area under the concentration-time curve

Time frame
From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
3

t1/2

elimination half-life

Time frame
From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
4

Vz/F

apparent volume of distribution

Time frame
From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbisko Therapeutics Co, Ltd

Lead sponsor

Source ClinicalTrials.gov
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