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New pill for tough tumors enters human testing

NCT ID NCT04192344

Disease control Sponsor: Abbisko Therapeutics Co, Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests an experimental pill called ABSK021 in people with advanced solid tumors (including a rare joint tumor called TGCT) who have run out of standard options. The main goal is to check safety and find the best dose, while also seeing if the drug can shrink tumors. About 276 participants will take the drug by mouth and be closely monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 276 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 For patients with tenosynovial giant cell tumor (TGCT) : 1. A diagnosis of TGCT \[i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board); 2. Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans; 3. Others Exclusion Criteria: * 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 For patients with tenosynovial giant cell tumor (TGCT) : 1. Known allergy or hypersensitivity to any component of the investigational drug product 2. For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US） 3. Others

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Conditions

The condition(s) this trial relates to.

Giant Cell Tumor of Tendon Sheath neoplasm tenosynovial giant cell tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms Tenosynovial giant cell tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beijing Jishuitan Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Hebei Medical University Third Hospital

    COMPLETED

    Shijiazhuang, Hebei, China

  • Henan Cancer Hospital

    ACTIVE_NOT_RECRUITING

    Zhengzhou, Henan, China

  • Huashan Hospital of Fudan University

    COMPLETED

    Shanghai, Shanghai Municipality, China

  • Jiangsu Province Hospital

    ACTIVE_NOT_RECRUITING

    Nanjing, Jiangsu, China

  • Liaoning Cancer Hospital

    COMPLETED

    Shenyang, Liaoning, China

  • MD Anderson Cancer Center

    COMPLETED

    Houston, Texas, 77030, United States

  • Nanjing Drum Tower Hospital

    ACTIVE_NOT_RECRUITING

    Nanjing, Jiangsu, China

  • Precision NextGen Oncology

    ACTIVE_NOT_RECRUITING

    Beverly Hills, California, 90212, United States

  • SCRI at HealthOne

    COMPLETED

    Denver, Colorado, 80218-1238, United States

  • Shanghai Sixth People's Hospital

    COMPLETED

    Shanghai, Shanghai Municipality, China

  • The First Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangdong, Guangzhou, China

  • The First Affiliated Hospital of Zhengzhou Universtity

    COMPLETED

    Zhengzhou, Henan, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The Winship Cancer Institute of Emory University

    COMPLETED

    Atlanta, Georgia, 30322, United States

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xi'an Hong Hui Hospital

    RECRUITING

    Xian, Shanxi, China

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