NeoplasmsPhase 1NCT04964375
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
A Phase 1 study testing ABSK043 oral capsule in people with Neoplasms, run by Abbisko Therapeutics Co, Ltd at 20 sites in 2 countries.
Trial summary
This is a Phase 1, Open-Label Study of ABSK043 to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced Solid Tumor. Preliminary antitumor activity will also be assessed. Investigate the pharmacodynamics (PD) effects and Investigate the metabolites of oral ABSK043 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- ABSK043 oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 31 Aug 2021to 30 Dec 2027
- 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
- Patient should understand, sign, and date the written voluntary informed consent form prior to screening.
- Male or female aged 18 years or older (or other age range required by local regulations or IRB).
- For Escalation part: patients must have histologically confirmed solid tumors that have progressed on or intolerance to standard therapy or whom no standard therapy exists or whom refuse to receive standard therapy；
- For Expansion Part:
- Melanoma cohort: Patients must have histologically confirmed melanoma that have have progressed on or intolerance to standard therapy(including immune-checkpoint inhibitors) or whom no standard therapy exists or whom refuses to receive standard therapy
- MSI-H/dMMR cohort: Patients must have histologically confirmed solid tumors harboring MSI-H or dMMR that have progressed on or intolerance to standard therapy or whom no standard therapy exists or whom refuses to receive standard therapy.
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- Patients must have at least one measurable target lesion according to RECIST 1.1.
- Patients are willing to receive biopsy. 4. ECOG performance status 0 or 1 5. Life expectancy ≥3 months 6. Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study drug:
- Absolute neutrophil count (ANC) ≥1.5×109/L
- Platelet count (PLT) ≥75×109/L without transfusions within 14 days before 1st dose
- Hemoglobin (Hb) ≥90 g/L
- Total bilirubin (TBIL) ≤1.5×ULN
- Aspartate transaminase (AST)/alanine transaminase (ALT), ≤3×ULN (≤5 × ULN in the presence of hepatic metastases).
- Serum creatinine (Cr) of ≤1.5×ULN for the reference laboratory or creatinine clearance (Crcl) ≥50 mL/min based either on urine collection or Cockcroft-Gault estimation
Who cannot join
- Known allergy or hypersensitivity to any component of the investigational product.
- For expansion part MSI-H or dMMR cohort only: previously treated with PD-(L)1 pathway inhibitors (including monoclonal antibody and small molecular agents).
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, etc.
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan, history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- For expansion part only: Has a known additional malignancy that is progressing or required active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or other in situ cancers.
- 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.
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- Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy or other investigational drugs received in previous clinical trial ≤4 weeks; endocrine therapy ≤2 weeks or ≤5-half-life (whichever is shorter) 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.
- Vaccination with a live, attenuated vaccine within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivate vaccines (e.g., COVID-19 vaccines, inactivated influenza vaccines).
- Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤1 severity (CTCAE v5.0) with the exception of alopecia, vitiligo or event(s) that is considered non-clinical meaningful by the Investigator.
- History of Grade ≥3 immune-related adverse event(s) occurred in previous treatment.
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial (patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study; patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have baseline and subsequent tumor assessments performed using MRI; the use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
- For expansion part only: last treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to first dose of study treatment.
- Concomitant use of the drugs/remedies that may cause pharmacokinetic drug-drug interactions; Consumption of grapefruit juice, grapefruit hybrids, pomegranates, starfruit, pomelos, Seville oranges or juice or products within 7 days prior to the first dose of study medication (for Escalation Part only).
- Active central nervous system (CNS) metastases including cerebral edema, system hormone treatment, disease progression due to intracranial lesions, leptomeningeal metastasis, and other clinical symptoms related to CNS metastases (if stable disease>8 weeks after treatment and free from glucocorticoids can be enrolled).
- Impaired cardiac function or clinically significant cardiac disease, including any one of the following:
- New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiacarrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
- Baseline prolongation of the rate-corrected QT interval based on repeated demonstration of QTcF >480 ms or history of long QT interval corrected (QTc) syndrome (Note: QTc interval corrected by Fridericia's formula). Left ventricular ejection fraction (LVEF) <50% or below the lower limit of normal(whichever is higher)
- Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection or active tuberculosis. Positive tests for hepatitis B virus surface antigen (HBsAg), or antibody to hepatitis B core Ag or hepatitis C RNA in serum. (subjects with history of hepatitis C infection but negative hepatitis C virus polymerase chain reaction (PCR) test and subjects with hepatitis B with positive hepatitis B surface antibody are allowed)
- Patients with refractory/uncontrolled ascites or pleural effusion. Patients with indwelling catheters are allowed.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to the start of study drug.
- Non-surgically sterilized male or female patients of childbearing potential must agree to use effective methods of birth control during the study and for up to 6 months after the last dose of study drug.
- Sexually active males unless they use a condom during intercourse while taking drug and for 5 compound half-lives plus 60 days after stopping study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
- Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
China17 sites
Chongqing University Cancer Hospital
Chongqing
Fujian Cancer hospital
Fuzhou
First Affiliated Hospital of Gannan Medical University
Ganzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
The Second Hospital of Anhui Medical University
Hefei
Mianyang Central Hospital
Mianyang
Jiangsu Province Hospital
Nanjing
Shanghai Chest Hospital
Shanghai
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai
Yuebei People's Hospital
Shaoguan
Liaoning Cancer Hospital
Shenyang
Renmin Hospital of Wuhan University
Wuhan
Union Hospital Tongji Medical College Huazhong University of science and technology
Wuhan
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an
Xiangyang Central Hospital
Xiangyang
Yanbian University Hospital（Yanbian Hospital）
Yanbian
Australia3 sites
Icon Cancer Centre South Brisbane
Brisbane, Queensland, 4101
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria
Sydney South West Private Hospital
Liverpool
About this study
Official title: A Phase 1, Open-Label Study of ABSK043 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
This is a Phase 1, Open-Label Study of ABSK043 to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced Solid Tumor.
Preliminary antitumor activity will also be assessed. Investigate the pharmacodynamics (PD) effects and Investigate the metabolites of oral ABSK043
Read the detailed description
The study will start with a dose escalation part of single-agent ABSK043 administered in repeated 28-day cycles in patients with advanced solid for safety and tolerability. The expansion part of oral ABSK043 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
- Being tested
- ABSK043 oral capsule
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK043 oral capsuleDrug
ABSK043 is a novel, oral small molecule inhibitor of PD-L1
| Study group | Role | What they receive |
|---|---|---|
| ABSK043 | Experimental | Dose escalation of oral ABSK043 with a starting dose of 200mg once daily will be guided by"BOIN" escalation rules based on safety data until an MTD has been identified or a RDE. For each dose,In the escalation part, sequential cohorts of patients will receive an oral dose of ABSK043 in repeated 28-day cycles. Starting dose level will be 200 mg QD. Cohort 3 on 800mg will be switched to 400mg BID.Then, patients will continuously receive ABSK043 （total daily dose） in repeated 28-day cycles.For the Dose Expansion Phase, patients will each receive orally administered doses of ABSK043 at the RDE in repeated 28-day cycles. Receives: Drug: ABSK043 oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (14)
PFS
Progression-Free Survival
Measured: throughout study completion, on average of half year
DCR
Disease control rate up to 24 weeks
Measured: throughout study completion, on average of half year
DOR
Duration of response
Measured: throughout study completion, on average of half year
Cmax
maximun observed concentration
Measured: at the end of Cycle 1 Day15 (each cycle is 28 days)
Tmax
time to maximum observed concentration
Measured: at the end of Cycle 1 Day15 (each cycle is 28 days)
AUC
area under the concentration-time curve
Measured: at the end of Cycle 1 Day15 (each cycle is 28 days)
t1/2
half-life
Measured: at the end of Cycle 1 Day15 (each cycle is 28 days)
Vz/F
apparent volume of distribution
Measured: at the end of Cycle 1 Day15 (each cycle is 28 days)
CL/F
apparent oral clearance
Measured: at the end of Cycle 1 Day15 (each cycle is 28 days)
Css_max
maximun observed concentration of steady-state
Measured: at the end of Cycle 1 Day15 (each cycle is 28 days)
Css_min
minimum observed concentration of steady-state
Measured: at the end of Cycle 1 Day15 (each cycle is 28 days)
AUCss
area under the concentration-time curve of steady-state
Measured: at the end of Cycle 1 Day15 (each cycle is 28 days)
Rac
accumulation rate
Measured: at the end of Cycle 1 Day15 (each cycle is 28 days)
ORR
Overall response rate
Measured: throughout study completion, on average of half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start31 Aug 2021
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jermaine Coward, Principal investigator, Icon Cancer Centre South Brisbane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964375
- Sponsor's protocol ID
- ABSK043-101
- Status last verified
- Nov 2026
- First submitted
- 24 Jun 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study of ABSK043 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04964375
- Acronym / sponsor ID
- ABSK043-101
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 Jul 2021 (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 a Phase 1, Open-Label Study of ABSK043 to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced Solid Tumor.
Preliminary antitumor activity will also be assessed. Investigate the pharmacodynamics (PD) effects and Investigate the metabolites of oral ABSK043
Detailed description
The study will start with a dose escalation part of single-agent ABSK043 administered in repeated 28-day cycles in patients with advanced solid for safety and tolerability. The expansion part of oral ABSK043 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 |
|---|---|---|
| ABSK043 | Experimental | Drug: ABSK043 oral capsuleDose escalation of oral ABSK043 with a starting dose of 200mg once daily will be guided by"BOIN" escalation rules based on safety data until an MTD has been identified or a RDE. For each dose,In the escalation part, sequential cohorts of patients will receive an oral dose of ABSK043 in repeated 28-day cycles. Starting dose level will be 200 mg QD. Cohort 3 on 800mg will be switched to 400mg BID.Then, patients will continuously receive ABSK043 （total daily dose） in repeated 28-day cycles.For the Dose Expansion Phase, patients will each receive orally administered doses of ABSK043 at the RDE 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 (14 listed)
- Patient should understand, sign, and date the written voluntary informed consent form prior to screening.
- Male or female aged 18 years or older (or other age range required by local regulations or IRB).
- For Escalation part: patients must have histologically confirmed solid tumors that have progressed on or intolerance to standard therapy or whom no standard therapy exists or whom refuse to receive standard therapy；
- Melanoma cohort: Patients must have histologically confirmed melanoma that have have progressed on or intolerance to standard therapy(including immune-checkpoint inhibitors) or whom no standard therapy exists or whom refuses to receive standard therapy
- MSI-H/dMMR cohort: Patients must have histologically confirmed solid tumors harboring MSI-H or dMMR that have progressed on or intolerance to standard therapy or whom no standard therapy exists or whom refuses to receive standard therapy.
Key exclusion criteria (24 listed)
- Known allergy or hypersensitivity to any component of the investigational product.
- For expansion part MSI-H or dMMR cohort only: previously treated with PD-(L)1 pathway inhibitors (including monoclonal antibody and small molecular agents).
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, etc.
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan, history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- For expansion part only: Has a known additional malignancy that is progressing or required active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or other in situ cancers.
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 |
|---|---|---|
| ABSK043 oral capsuleABSK043 is a novel, oral small molecule inhibitor of PD-L1 | Drug | ABSK043 |
Primary outcome
DLT
Time frame: At the end of Cycle 1 (each cycle is 28 days)
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)
14 secondary outcomes
PFS
Time frame: throughout study completion, on average of half year
DCR
Time frame: throughout study completion, on average of half year
DOR
Time frame: throughout study completion, on average of half year
Cmax
Time frame: at the end of Cycle 1 Day15 (each cycle is 28 days)
Tmax
Time frame: at the end of Cycle 1 Day15 (each cycle is 28 days)
AUC
Time frame: at the end of Cycle 1 Day15 (each cycle is 28 days)
t1/2
Time frame: at the end of Cycle 1 Day15 (each cycle is 28 days)
Vz/F
Time frame: at the end of Cycle 1 Day15 (each cycle is 28 days)
CL/F
Time frame: at the end of Cycle 1 Day15 (each cycle is 28 days)
Css_max
Time frame: at the end of Cycle 1 Day15 (each cycle is 28 days)
Css_min
Time frame: at the end of Cycle 1 Day15 (each cycle is 28 days)
AUCss
Time frame: at the end of Cycle 1 Day15 (each cycle is 28 days)
Rac
Time frame: at the end of Cycle 1 Day15 (each cycle is 28 days)
ORR
Time frame: throughout study completion, on average of half year
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 6 Nov 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. This study is not recruiting at the moment.
Jermaine Coward principal investigator
Icon Cancer Centre South Brisbane
20 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 ABSK043 oral capsule in people with Neoplasms, run by Abbisko Therapeutics Co, Ltd at 20 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 14 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China, Australia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (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 6 Nov 2026.