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A Study of ABSK-021 for Advanced Solid Tumors and Tenosynovial Giant Cell Tumor

This study is testing a new targeted therapy called ABSK-021, given as an oral capsule, for people with advanced solid tumors or tenosynovial giant cell tumor (TGCT). It aims to find out how safe ABSK-021 is, how well your body tolerates it, and how it moves through your body. The study will also look for early signs that the treatment might shrink tumors. You may be able to join if you are 18 or older, have a solid tumor that has progressed or for which standard treatments aren't working, and meet other health requirements. The study plans to enroll up to 276 participants. The current status of the study is unclear.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving ABSK-021. It will start with a dose escalation phase to find the safest dose, followed by an expansion phase to further evaluate safety and early anti-tumor activity.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored throughout the study, which is expected to last an average of 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04192344

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Abbisko Therapeutics Co, Ltd
~276 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:ABSK021

At a glance

Recruiting sites
5 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of DLTs
Measured over At the end of Cycle 1 (each cycle is 28 days)
+1 more outcome measured

Conditions

Neoplasms
Tenosynovial Giant Cell Tumor

Explore related trials

Solid NeoplasmTenosynovial Giant Cell Tumor

NCT04192344

Where you'd take part

This study runs at 17 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangdong, Guangzhou, Chinano site contact published

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, Chinano site contact published

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, Chinano site contact published

    Recruiting

  • Xi'an Hong Hui Hospital

    Xian, Shanxi, Chinano site contact published

    Recruiting

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei, Chinano site contact published

    Completed

  • Henan Cancer Hospital

    Zhengzhou, Henan, Chinano site contact published

    Active, not recruiting

  • Huashan Hospital of Fudan University

    Shanghai, Shanghai Municipality, Chinano site contact published

    Completed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Siqing Fu, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

YUAN LU
[email protected]
+86-21-68910052
Email the study team

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Eligibility criteria

Inclusion

Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists
ECOG (electrocorticogram) performance status 0\~1
Life expectancy ≥ 3 months
Adequate organ function and bone marrow function

Exclusion

Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colony stimulating factor 1 receptor) pathway inhibitors
Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment
Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication
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 (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment)
Major surgery within 4 weeks of the first dose of study drug and all surgical wounds must be healed and free of infection or dehiscence
Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤2 severity (CTCAE v5.0) with the exception of alopecia and vitiligo
Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug
Concomitant use of strong inhibitors or inducers of CYP3A4
Active central nervous system (CNS) metastases
Impaired cardiac function or clinically significant cardiac disease
Patients with Gilbert's Syndrome or other underlying conditions that may lead to a greater likelihood of developing LFT(liver function test) abnormalities during the study
Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection
Refractory/uncontrolled ascites or pleural effusion
Pregnant or nursing

What this trial measures

  • Incidence of DLTsAt the end of Cycle 1 (each cycle is 28 days)

    DLT(dose-limiting toxicity)

  • Incidence and Severity of AEsThrough study completion, an average of 6 months

    Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)