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Advanced Solid Tumor, Non-small Cell Lung CancerPhase 1/2NCT03389815

A Study Evaluates the Safety, Pharmacokinetics and Efficacy of WX-0593 in Advanced Solid Tumor Patients

A Phase 1/2 study testing WX-0593 Tablets in people with Advanced Solid Tumor, Non-small Cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of WX-0593 alone in the treatment of advanced cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
WX-0593 Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
14 Sep 2017to Dec 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 to 70 years, inclusive.
  • Female or male
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Life expectancy of at least 12 weeks.
  • At least one measurable lesion (according to RECIST v1.1)
  • Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy with ALK/ROS1+ (For the expansion phase, patients must have NSCLC with ALK+ ):
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  • Patients with advanced tumor (eg. NSCLC, lymphoma, inflammatory myofibroblastic tumor) who failed in standard treatment (eg. resistant of ALK inhibitors or chemotherapy)
  • Patients with advanced NSCLC who cannot accept chemotherapy or intolerance with chemotherapy.
  • Advanced NSCLC patients who could not afford ALK inhibitor treatment.
  • Patients with treated or untreated asymptomatic Central Nervous System（CNS） metastases may be allowed to enroll.
  • Patients must have normal function as defined: ANC≥1.5*10^9/L PLT≥100*10^9/L， Total Bilirubin （TBIL）≤1.5*Upper Limit of Normal（ULN） ( Gilbert's Syndrome TBIL ≤3.0*ULN and DBIL≤1.5*ULN )，Alanine Transaminase （ALT）and Aspartate Aminotransferase（AST）≤2.5*ULN. For liver metastasis patients, ALT and AST≤5*ULN, Cr≤1.5*ULN, LVEF≥50%.
  • Any surgery or radiation (expect for palliative radiation) must have been completed at least 4 weeks prior to first dosing. Palliative radiation must have been completed at least 48 hours prior to first dosing.
  • All related adverse events from previous anti-cancer therapies must have recovered to ≤ Grade 1 (except for alopecia).
  • Patients must be able to understand and volunteer to sign the informed consent.

Who cannot join

  • Clinically significant cardiovascular disease within 3 months prior to first dosing.
  • Ongoing cardiac dysrhythmias, or any grade of uncontrolled atrial fibrillation, or prolonged QT interval (QTc > 480 ms).
  • Patients need medications that may prolong QT interval or induce torsades de pointes within 14 days prior to the first dosing or during the study.
  • Peripheral neuropathy ≥ Grade 3 according to CTCAE 4.03.
  • Patients who received continuous use of steroids for more than 30 days, or who need long-term use of steroid hormones or other immunosuppressive agents.
  • History of extensive disseminated/bilateral pulmonary interstitial fibrosis, interstitial fibrosis or interstitial lung disease of Grade 3/4 .
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  • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of WX-0593.
  • Patients who are receiving warfarin sodium (Coumadin) or any other coumadin-derived anticoagulants，and patients with coagulation disturbance and bleeding tendency.
  • Patient has received other investigational drug within 1 month.
  • Patients with acute or chronic infectious medical conditions, including active hepatitis (Hepatitis A、 Hepatitis B、 Hepatitis C ) or HIV infection.
  • Patients who received prior anti-cancer therapy within 2 weeks (t1/2 ≤ 3 days) or within 4 weeks (3 days < t1/2）. Patients previously treated with crizotinib could start WX-0593 dosing after 1 week from the last dosing.
  • Patients who could not discontinue therapy with potent CYP3A4 inhibitors or inducers within 1 week prior first dosing, or patients who need therapy with CYP3A4 inhibitors or inducers during the study.
  • Patients received medications known to be metabolized by CYP3A4 and with narrow therapeutic indices, who could not discontinue within 1 week prior to the start of WX-0593 administration. Patients who need therapy with those medications during the study.
  • Females who are pregnant or breastfeeding.
  • Patients with childbearing potential must agree to use adequate contraception for the duration of treatment and for 6 months after the study.
  • Drug abusers and alcoholics.
  • History of definite nerves or psychosis diseases including epilepsy or dementia.
  • History of other malignancy.
  • Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, M.D., 86-010-87788293, syuankaipumc@126.com

    Recruiting

Other trials in China

About this study

Official title: The Dose-escalation Study Followed by an Extension Phase Evaluating the Safety, Pharmacokinetics and Efficacy of WX-0593 in Advanced Solid Tumor Patients With Anaplastic Lymphoma Kinase（ALK）/Receptor Tyrosine Kinase（ROS1） Positive

The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of WX-0593 alone in the treatment of advanced cancer.

Read the detailed description

The first part is a single-arm, phase 1, open label, dose-escalation design in patients with anaplastic lymphoma kinase（ALK）/receptor tyrosine kinase（ROS1） Positive ALK/ROS1-positive solid tumor. The second part is an expansion in non-small cell lung Cancer (NSCLC) characterized by abnormalities in anaplastic lymphoma kinase(ALK) expression.

Being tested
WX-0593 Tablets
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • WX-0593 TabletsDrug

    Also called FL-006

    tablets, dosage ranged from 30 mg to 300 mg, quaque die（QD）

Study groups in NCT03389815
Study groupRoleWhat they receive
WX-0593 TabletsExperimentalThe first part is a dose-escalation design in patients with ALK/ROS1-positive solid tumor. The second part is an expansion in non-small cell lung Cancer (NSCLC) characterized by abnormalities in ALK expression.
Receives: Drug: WX-0593 Tablets

What is being measured

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

  1. Maximum tolerated dose（MTD）

    The MTD is determined by the number of the participants in cohort who suffer a dose-limiting toxicity (DLT). The MTD is defined as the former dose at which more than one third of the participants develop a DLT. If no DLTs are observed, the MTD is not reached.

    Measured: 28 days

Secondary outcomes (16)

  1. Tmax of WX-0593

    Pharmacokinetics of WX-0593 by assessment of time to Cmax

    Measured: 28 days

  2. Cmax of WX-0593

    Pharmacokinetics of WX-0593 by assessment of maximum plasma WX-0593 concentration.

    Measured: 28 days

  3. Cmin of WX-0593

    Pharmacokinetics of WX-0593 by assessment of minimum plasma WX-0593 concentration.

    Measured: 28 days

  4. AUC of WX-0593

    Pharmacokinetics of WX-0593 by assessment of area under the plasma concentration time curve from zero to infinity

    Measured: 28 days

  5. tl/2 of WX-0593

    Pharmacokinetics of WX-0593 by assessment of the terminal half-life

    Measured: 28 days

  6. Cssmin of WX-0593

    Cmin of WX-0593 at steady state

    Measured: 28 days

  7. Cssmax of WX-0593

    Cmax of WX-0593 at steady state

    Measured: 28 days

  8. Css-av of WX-0593

    Mean plasma concentration of WX-0593 at steady state

    Measured: 28 days

  9. AUCss of WX-0593

    area under the curve of WX-0593 at steady state

    Measured: 28 days

  10. DF of WX-0593

    Pharmacokinetics of WX-0593 by assessment of degree of fluctuation

    Measured: 28 days

  11. Vz of WX-0593

    volume of distribution during terminal phase after WX-0593 administration

    Measured: 28 days

  12. CLs of WX-0593

    total plasma,serum or blood clearance of WX-0593 after administration

    Measured: 28 days

  13. Objective Response Rate (ORR)

    Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate (ORR) from baseline to final tumor assessment point after treatment. As Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, the percentage of subjects indicating PR (partial response) and CR (complete response) will be calculated.

    According to RECIST 1.1 criteria, complete response (CR) - the disappearance of all target lesions and partial response ( PR ) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

    Measured: From fist administration of WX-0593 to 28 days after last medication.

  14. Progression-free survival (PFS)

    PFS defined as the time from baseline to first observed disease progression or death from any cause.

    Measured: From fist administration of WX-0593 to 28 days after last medication.

  15. Disease Control Rate (DCR)

    DCR is the percentage of patients with best response of CR, PR or Stable Disease (SD).

    SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter.

    Measured: From fist administration of WX-0593 to 28 days after last medication.

  16. Duration of Response (DOR) and so on

    The DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date on which progressive disease (PD) is first noted or date of death.

    Measured: From fist administration of WX-0593 to 28 days after last medication.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2018
  2. Study start14 Sep 2017
  3. Primary completionJun 2020 (estimated)
  4. Study completionDec 2020 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03389815
Sponsor's protocol ID
WX0593-001
Status last verified
Dec 2017
First submitted
6 Dec 2017
Last updated
4 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang G, Wang Y, Zhao H, Zheng Q, Wang X, Jia L, Xin Q, Ma C, Zhang Y, Zheng S, Kang X. Translational Model-Informed Dose Selection for Iruplinalkib, a Selective Oral ALK/ROS1 Tyrosine Kinase Inhibitor. Clin Transl Sci. 2025 Jul;18(7):e70287. doi: 10.1111/cts.70287.

    PubMed 40650620

  • Shi Y, Fang J, Hao X, Zhang S, Liu Y, Wang L, Chen J, Hu Y, Hang X, Li J, Liu C, Zhang Y, Wang Z, Hu Y, Gu K, Huang J, Zhang L, Shan J, Ouyang W, Zhao Y, Zhuang W, Yu Y, Zhao J, Zhang H, Lu P, Li W, Si M, Ge M, Geng H. Safety and activity of WX-0593 (Iruplinalkib) in patients with ALK- or ROS1-rearranged advanced non-small cell lung cancer: a phase 1 dose-escalation and dose-expansion trial. Signal Transduct Target Ther. 2022 Jan 28;7(1):25. doi: 10.1038/s41392-021-00841-8.

    PubMed 35087031

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing WX-0593 Tablets in people with Advanced Solid Tumor, Non-small Cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

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 19 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: status not confirmed, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose（MTD） (time frame: 28 days). 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 NCT03389815, which also lists 2 linked publications.

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 4 Jan 2018.

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