NeoplasmsPhase 1NCT04192344
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
A Phase 1 study testing ABSK021 in people with Neoplasms and Tenosynovial Giant Cell Tumor, run by Abbisko Therapeutics Co, Ltd at 17 sites in 2 countries.
Trial summary
This 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Tenosynovial Giant Cell Tumor
- What is being tested?
- ABSK021
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 20 Jan 2020to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) :
- 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);
- Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;
- Others
Who cannot join
- 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
Show all 18Show fewer
- 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) :
- Known allergy or hypersensitivity to any component of the investigational drug product
- For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US）
- Others
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
China13 sites, 5 recruiting
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Xiaohui Niu, MD
Xiaohui Niu, MD
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Yong Zhou, MD
Yong Zhou, MD
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangzhou
Jingnan Shen, MD
Jingnan Shen, MD
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhaoming Ye, MD
Zhaoming Ye, MD
- Active, not recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
- Active, not recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
- Completed
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality
- Completed
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
- Completed
Liaoning Cancer Hospital
Shenyang, Liaoning
- Completed
Hebei Medical University Third Hospital
Shijiazhuang, Hebei
- Recruiting
Xi'an Hong Hui Hospital
Xian, Shanxi
Zhichao Tong, MD
Zhichao Tong, MD
- Active, not recruiting
Henan Cancer Hospital
Zhengzhou, Henan
- Completed
The First Affiliated Hospital of Zhengzhou Universtity
Zhengzhou, Henan
United States4 sites
- Completed
The Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
- Active, not recruiting
Precision NextGen Oncology
Beverly Hills, California, 90212
- Completed
SCRI at HealthOne
Denver, Colorado, 80218-1238
- Completed
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
This 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.
Read the detailed description
The study will start with a dose escalation part of single-agent ABSK021 administered in repeated 28-day cycles in patients with advanced solid for safety and tolerability. The expansion part of oral ABSK021 at recommended dose of expansion (RDE) will be followed for further evaluating safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.
- Conditions
- Neoplasms, Tenosynovial Giant Cell Tumor
- Being tested
- ABSK021
- Keywords
- Tenosynovial Giant Cell Tumor, TGCT, Solid tumors
- Medical subject headings
- Neoplasms, Giant Cell Tumor of Tendon Sheath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK021Drug
ABSK021 oral capsule
| Study group | Role | What they receive |
|---|---|---|
| ABSK021 | Experimental | Dose escalation of oral ABSK021 with a starting dose of 25mg once daily will be guided by"3+3" escalation rules based on safety data until an MTD has been identified or a RDE. For each dose, patients will first receive a single dose ABSK021 tablet(s) by mouth at Day -3 and be followed by a 3-day off as a run-in period to access the safety and PK of single-dose. Then, patients will continuously receive ABSK021 once daily (QD) in repeated 28-day cycles. Receives: Drug: ABSK021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLTs
DLT(dose-limiting toxicity)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Incidence and Severity of AEs
Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
Measured: Through study completion, an average of 6 months
Secondary outcomes (7)
PFS
Progression-Free Survival (PFS)
Measured: From date of enrollment until the date of first documented progression or death, assessed up to 12 months
DoR
Duration of Response (DoR)
Measured: From date of enrollment until the date of first documented progression or death, assessed up to 12 months
DCR
Disease Control Rate (DCR)
Measured: 24 weeks post-dose
Cmax
The peak plasma concentration of a drug after administration
Measured: Pre-dose and multiple timepoints (up to 72 hours) post-dose
tmax
Time to reach Cmax
Measured: Pre-dose and multiple timepoints (up to 72 hours) post-dose
Bioavailability
The systemically available fraction of a drug
Measured: Pre-dose and multiple timepoints (up to 72 hours) post-dose
Elimination half-life
The time required for the concentration of the drug to reach half of its original value
Measured: Pre-dose and multiple timepoints (up to 72 hours) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start20 Jan 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics Co, LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siqing Fu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192344
- Sponsor's protocol ID
- ABSK021-101
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2019
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04192344
- Acronym / sponsor ID
- ABSK021-101
- Conditions
- Neoplasms, Tenosynovial Giant Cell Tumor
- Keywords
- Tenosynovial Giant Cell Tumor, TGCT, Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 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.
Detailed description
The study will start with a dose escalation part of single-agent ABSK021 administered in repeated 28-day cycles in patients with advanced solid for safety and tolerability. The expansion part of oral ABSK021 at recommended dose of expansion (RDE) will be followed for further evaluating safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABSK021 | Experimental | Drug: ABSK021Dose escalation of oral ABSK021 with a starting dose of 25mg once daily will be guided by"3+3" escalation rules based on safety data until an MTD has been identified or a RDE. For each dose, patients will first receive a single dose ABSK021 tablet(s) by mouth at Day -3 and be followed by a 3-day off as a run-in period to access the safety and PK of single-dose. Then, patients will continuously receive ABSK021 once daily (QD) in repeated 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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);
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABSK021ABSK021 oral capsule | Drug | ABSK021 |
Primary outcome
Incidence of DLTs
Time frame: At the end of Cycle 1 (each cycle is 28 days)
DLT(dose-limiting toxicity)
Incidence and Severity of AEs
Time frame: Through study completion, an average of 6 months
Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
7 secondary outcomes
PFS
Time frame: From date of enrollment until the date of first documented progression or death, assessed up to 12 months
DoR
Time frame: From date of enrollment until the date of first documented progression or death, assessed up to 12 months
DCR
Time frame: 24 weeks post-dose
Cmax
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
tmax
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
Bioavailability
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
Elimination half-life
Time frame: Pre-dose and multiple timepoints (up to 72 hours) post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Siqing Fu, MD principal investigator
M.D. Anderson Cancer Center
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABSK021 in people with Neoplasms and Tenosynovial Giant Cell Tumor, run by Abbisko Therapeutics Co, Ltd at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YUAN LU (+86-21-68910052, clinical@abbisko.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLTs (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.