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Solid TumorPhase 1NCT05627063

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX in Patients With Advanced Solid Tumors

A Phase 1 study testing ABSK121-NX in people with Solid Tumor, run by Abbisko Therapeutics Co, Ltd at 24 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK121-NX administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
ABSK121-NX
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
24 sitesin 2 countries
Study dates
26 Jun 2023to 30 Jan 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

  • Patients should understand, sign, and date the written informed consent form prior to screening
  • Male or female age 18 years or older
  • Patients with histologically confirmed locally-advanced or metastatic solid tumors who have progressed on, or are intolerant of standard therapy, or for whom no standard therapy exists, or reject standard therapy
  • For RDE-confirmation in the escalation part: patients with selected advanced solid tumors, i.e.,
  • Patients must have the following FGFR genetic alterations based on central laboratory tests or existing test reports of tumor tissue and/or blood:
  • Urothelial carcinoma (UC): pre-specified FGFR3 mutations (R248C, S249C, G370C, Y373C) or FGFR2/3 fusions (partner gene is previously described or in frame), or
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  • Intrahepatic Cholangiocarcinoma (iCCA): FGFR2 fusions or rearrangements which containing an intact kinase domain as follows:
  • FGFR2 fusions: FGFR2 rearrangements with a literature-derived known partner gene regardless of strand or frame, or FGFR2 rearrangements in the same 5' to 3' orientation and in frame with a novel partner gene
  • FGFR2 rearrangements: FGFR2 rearrangements with one breakpoint in the hotspot region (intron 17-exon 18) and the other breakpoint in an intergenic region or within another gene, or intragenic duplication of the kinase domain (exon 9-17)
  • Patients must have at least one measurable target lesion according to RECIST 1.1
  • For the expansion Part:
  • 1) Patients must have the following FGFR genetic alterations based on central laboratory tests or existing test reports of tumor tissue and/or blood:
  • Urothelial carcinoma: pre-specified FGFR3 mutations (R248C, S249C, G370C, Y373C) or FGFR2/3 fusions (partner gene is previously described or in frame)
  • Cholangiocarcinoma: FGFR2 fusions or rearrangements which containing an intact kinase domain as follows:
  • FGFR2 fusions: FGFR2 rearrangements with a literature-derived known partner gene regardless of strand or frame, or FGFR2 rearrangements in the same 5' to 3' orientation and in frame with a novel partner gene
  • FGFR2 rearrangements: FGFR2 rearrangements with one breakpoint in the hotspot region (intron 17-exon 18) and the other breakpoint in an intergenic region or within another gene, or intragenic duplication of the kinase domain (exon 9-17)
  • Other tumor types: solid tumors harboring FGFR1-4 alterations including activating mutations, fusions or rearrangements and amplifications, e.g., advanced/metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma harboring the FGFR2 amplifications, or iCCA patients or UC patients with other FGFR alterations not mentioned above, are also allowed
  • 2) Patients must have at least one measurable target lesion according to RECIST 1.1
  • 3) Previous FGFR inhibitors treated and progressed cohort in UC or iCCA patients: received treatment with FGFR inhibitors and experienced disease progression/recurrence during or after FGFR inhibitors treatment
  • 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 (without the use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF, M-CSF) within 7 days before testing)
  • Platelet count (PLT) ≥100×109/L (without transfusion within 14 days before testing)
  • Hemoglobin (Hb) ≥90 g/L (without transfusion within 7 days before testing)
  • Total bilirubin (TBIL) ≤1×ULN
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5×ULN
  • Creatinine clearance (Crcl) ≥60 mL/min based on Cockcroft-Gault formula
  • Electrolyte: magnesium within 0.85 to 1.25 × institutional normal limits, sodium ≥130 mmol/L, potassium within institutional normal limits 7. For patients participating exploration of food effect:
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  • be able to eat a standardized high-fat, high caloric meal within 30 minutes
  • be able to fast for 10 hours

Who cannot join

  • Known allergy or hypersensitivity to any component of the investigational product
  • RDE-confirmation in Escalation part: Prior treatment with any FGFR inhibitors
  • Expansion part:
  • <!-- -->
  • Previously FGFR-inhibitors naive cohorts in UC or iCCA patients: Prior treatment with any FGFR inhibitors
  • Other solid tumors cohort: Prior treatment with any FGFR inhibitors
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  • 4. Has a known additional malignancy that is progressing or has required active treatment.
  • 5. Has persistent phosphate level >ULN during screening (within 14 days prior to the first dose of study treatment) and despite medical management
  • 6. Unable to swallow capsules or tablets or malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction. If any of these conditions exist, the site should discuss with the sponsor to determine patient eligibility
  • 7. Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin received ≤ 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy, antibody therapy or other investigational drugs received ≤4 weeks; endocrine therapy ≤2 weeks or ≤5 half-lives (whichever is shorter) prior to initiation of study treatment
  • 8. Major surgery within 4 weeks of the first dose of study drug. Note that all surgical wounds must be healed and free of infection or dehiscence
  • 9. 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 and grade 2 peripheral neurotoxicity
  • 10. Potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort). Refer to https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers for a list of drugs
  • 11. Active central nervous system (CNS) metastases including presence of cerebral edema, requirement for systemic steroid treatment, disease progression due to intracranial lesions, leptomeningeal metastasis, and other clinical symptoms related to CNS metastases
  • 12. 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 cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure,
  • Baseline prolongation of the rate-corrected QT interval based on repeated demonstration of QTcF >470 ms (average of screening triplicates) 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 institutional lower limit of normal (whichever is higher)
  • 13. Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody
  • 14. Exclusion of hepatitis infection based on the following results and/or criteria:
  • Active hepatitis B infection: positive tests for hepatitis B surface antigen (HBsAg), or antibody to hepatitis B core antigen (anti-HBc). A patient with positive tests for HBsAg or anti-HBc but with HBV-DNA measurements lower than detectable (or per local practice) can be enrolled,
  • Active hepatitis C infection: positive Hepatitis C virus antibody. If positive antibody to hepatitis C Virus (anti-HCV) is detected, Hepatitis C virus RNA by polymerase chain reaction (PCR) is necessary. A patient with positive anti-HCV but with a negative test for HCV RNA can be enrolled
  • 15. Any of the following ophthalmological criteria:
  • Current evidence or previous history of retinal pigment epithelial detachment (RPED) /Central serous retinopathy (CSR)
  • Previous laser treatment or intra-ocular injection for treatment of macular degeneration
  • Current evidence or previous history of dry or wet age-related macular degeneration
  • Current evidence or previous history of retinal vein occlusion (RVO)
  • Current evidence or previous history of retinal degenerative diseases (e.g., hereditary)
  • Diabetic retinopathy with macular edema
  • Current evidence or previous history of any other clinically relevant chorioretinal defect
  • Uncontrolled glaucoma or intraocular pressure > 21 mmHg [after intervention per local standard of care (SOC)]
  • History of systemic disease or ophthalmologic disorders requiring chronic use of ophthalmic steroids
  • Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks prior to first dose) or actively progressing
  • Current evidence or previous history of corneal pathology such as keratopathy, corneal abrasion or ulceration, or current evidence of conjunctivitis
  • 16. Patients with refractory/uncontrolled ascites or pleural effusion
  • 17. 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
  • 18. Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control during the study and for approximately 6 months after the last dose of study drug. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid
  • 19. Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines (e.g., COVID-19 vaccines, inactivated influenza vaccines)
  • 20. 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
  • 21. Planned major surgery during study treatment

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

China20 sites

  • Jilin Cancer Hospital

    Changchun, Jilin

  • Hunan Central Hospital

    Changsha, Hunan

  • West China School of Medicine/West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

  • Fujian Cancer Hospital (Department of Hepatobiliary and Pancreatic Oncology /Phase I Ward)

    Fuzhou

  • Harbin Medical University Cancer Hospital (Gastroenterology Department 2nd Ward)

    Haerbin

  • Zhejiang University Cancer Hospital

    Hangzhou, Zhejiang

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan

  • Mianyang Central Hospital

    Mianyang, Sichuan

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Shanghai East Hospital Tongji University

    Shanghai, Shanghai Municipality

  • Zhongshan Hospital of Fudan University (Hepatological Surgery Department)

    Shanghai

  • Zhongshan Hospital of Fudan University (Medical Oncology Department)

    Shanghai

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Liaoning Cancer Hospital (Phase I Ward)

    Shenyang

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Yantai Yuhuangding Hospital (Department of Medical Oncology, 1)

    Yantai

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

United States4 sites

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89119

Other trials in United States

About this study

Official title: A Phase 1, Open-Label Study of ABSK121-NX to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors

This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK121-NX administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK121-NX at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.

Read the detailed description

Escalation Part:

Dose escalation of oral ABSK121-NX will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. During the dose escalation part of the study, patients will receive a single dose of ABSK121 on Day -7 followed by a 7-day washout (Day -7 dosing day as 1st day of wash out) as a run-in period to access the safety and PK of ABSK121-NX. Then, patients will continuously receive ABSK121-NX once daily (QD) beginning at C1D1.

The dose escalation will start at 3 mg QD followed by dose escalation of a total of 8 potential dose levels. Once RDE is determined, an RDE-confirmation group of up to 24 more patients may be enrolled at the selected dose levels to further evaluate safety and efficacy (up to 12 per dose level/regimen), if approved by the sponsor. In addition, a preliminary food-effect (FE) may be evaluated in Cycle 1 D15 or later in at least 6 patients from the RDE- confirmation part.

After the RDE is determined in the dose escalation part, the dose expansion phase will be conducted.

Expansion Part:

When health authorities outside US require that the safety data in the local population be provided prior to the expansion part, a minimum of 3 local subjects will be enrolled and treated at the selected RDE dose level first in that country/region to evaluate the tolerability of ABSK121-NX. The inclusion and exclusion criteria for escalation part will apply for these subjects. After similar safety and tolerability of ABSK121-NX in patients in the relevant locality have been confirmed by local Investigators and the Sponsor, additional patients will be allowed to enroll in the expansion part.

Conditions
Solid Tumor
Being tested
ABSK121-NX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABSK121-NXDrug

    In the escalation part, patients will receive a single dose of oral ABSK121-NX on Day -7 followed by a 7-day washout (Day -7 dosing day as 1st day of wash out) as a run-in period to access the safety and PK of ABSK121-NX. Then, patients will continuously receive ABSK121-NX once daily (QD) starting at C1D1 and continuing in subsequent cycles (28-day cycles). The starting dose is 3mg QD. In the expansion part, patients will each receive oral ABSK121-NX at the RDE in repeated 28-day cycles.

Study groups in NCT05627063
Study groupRoleWhat they receive
ABSK121-NXExperimentalDose escalation of oral ABSK121-NX will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. Patients will receive a single dose of ABSK121-NX on Day -7 followed by a 7-day washout, as a run-in period to access the safety and PK of ABSK121-NX. Then, patients will continuously receive ABSK121-NX once daily (QD). The dose escalation will start at 3 mg QD followed by dose escalation of a total of 8 potential dose levels. Once RDE is determined, an RDE-confirmation group of up to 24 more patients may be enrolled at the selected dose levels to further evaluate safety and efficacy (up to 12 per dose level/regimen), if approved by the sponsor. In addition, a preliminary food-effect (FE) may be evaluated in at least 6 patients from the RDE- confirmation part. After the RDE is confirmed in the dose Escalation part, the dose Expansion phase will be conducted.
Receives: Drug: ABSK121-NX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of DLT

    dose-limiting toxicities (DLTs)

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. Incidence and severity of adverse events (AEs)

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

    Measured: Through study completion, an average of half year

Secondary outcomes (15)

  1. Cmax

    maximum observed concentration

    Measured: Through the study completion, an average of half year

  2. Tmax

    time to maximum observed concentration

    Measured: Through the study completion, an average of half year

  3. AUC

    area under the concentration-time curve

    Measured: Through the study completion, an average of half year

  4. t1/2

    half-life

    Measured: Through the study completion, an average of half year

  5. Vz/F

    apparent volume of distribution

    Measured: Through the study completion, an average of half year

  6. CL/F

    apparent oral clearance

    Measured: Through the study completion, an average of half year

  7. Cmax,ss

    maximum observed concentration of steady/state

    Measured: Through the study completion, an average of half year

  8. Cmin,ss

    minimum observed concentration of steady/state

    Measured: Through the study completion, an average of half year

  9. AUCtau,ss

    area under the concentration-time curve after multiple dose

    Measured: Through the study completion, an average of half year

  10. AR

    accumulation ratio

    Measured: Through the study completion, an average of half year

  11. ORR

    overall response rate

    Measured: Through the study completion, an average of half year

  12. DoR

    duration of response

    Measured: Through the study completion, an average of half year

  13. DCR

    disease control rate

    Measured: Through the study completion, an average of half year

  14. PFS

    Progression-free survival

    Measured: Through the study completion, an average of half year

  15. OS

    overall survival

    Measured: Through the study completion, an 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.

  1. First posted25 Nov 2022
  2. Study start26 Jun 2023
  3. Primary completion24 Sep 2026
  4. Study completion30 Jan 2027 (estimated)

Resources

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
169 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05627063
Sponsor's protocol ID
ABSK121-NX-101
Status last verified
Oct 2026
First submitted
15 Nov 2022
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABSK121-NX in people with Solid Tumor, run by Abbisko Therapeutics Co, Ltd at 24 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 32 inclusion and 40 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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?

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?

Incidence of 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?

On the ClinicalTrials.gov record for NCT05627063.

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 28 Oct 2026.

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