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OncoMatch/Clinical Trials/NCT06225804

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

Is NCT06225804 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ABSK112 for non-small cell lung cancer.

Phase 1RecruitingAbbisko Therapeutics Co, LtdNCT06225804Data as of May 2026

Treatment: ABSK112This 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR in-frame exon 20 insertion mutation

documented EGFR in-frame exon 20 insertion mutations confirmed by certificated local laboratories

Excluded: EGFR C797S mutation

NSCLC patients with EGFR Cys797Ser (C797S) mutation

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard therapy

patients have progressed on, rejected, or are intolerant of standard therapy, or for whom no standard therapy exists

Cannot have received: anti-cancer therapy

Previous anti-cancer therapy, including chemotherapy, radiotherapy, molecular targeted therapy, antibody therapy or other investigational drugs received ≤4 weeks prior to initiation of study treatment

Lab requirements

Blood counts

adequate bone marrow function

Kidney function

adequate organ function

Liver function

adequate organ function

Adequate organ function and bone marrow function.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Precision NextGen Oncology · Beverly Hills, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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