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OncoMatch/Clinical Trials/NCT04192344

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor

Is NCT04192344 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ABSK021 for neoplasms.

Phase 1RecruitingAbbisko Therapeutics Co, LtdNCT04192344Data as of May 2026

Treatment: ABSK021This 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.

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Extracted eligibility criteria

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: CSF-1/CSF-1R pathway inhibitor

Exception: not applicable for TGCT patients in US (expansion part only)

Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colony stimulating factor 1 receptor) pathway inhibitors

Cannot have received: chemotherapy (nitrosourea, mitomycin)

chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment

Cannot have received: chemotherapy

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

Cannot have received: radiotherapy

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

Cannot have received: endocrine therapy

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

Cannot have received: molecular targeted therapy

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

Cannot have received: corticosteroid

Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug

Lab requirements

Blood counts

bone marrow function

Kidney function

Liver function

Cardiac function

Impaired cardiac function or clinically significant cardiac disease excluded

Adequate organ function and bone marrow function; Impaired cardiac function or clinically significant cardiac disease

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

US trial sites

  • Precision NextGen Oncology · Beverly Hills, California
  • SCRI at HealthOne · Denver, Colorado
  • The Winship Cancer Institute of Emory University · Atlanta, Georgia
  • MD Anderson Cancer Center · Houston, Texas

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

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