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Advanced Solid TumorsPhase 1NCT05470933

A Study Explore WJ01075 Tablets in Patients With Advanced Solid Tumors

A Phase 1 study testing WJ01075 in people with Advanced Solid Tumors, run by Suzhou Junjing BioSciences Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase I study to Investigate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJ01075 tablets in patients with advanced malignant solid tumors, including phase Ia (dose escalation phase) and Phase Ib (dose expansion phase,cohort… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
WJ01075
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteChina
Study dates
23 Aug 2022to 18 Apr 2023
Phase
Phase 1
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with advanced malignant solid tumors clearly diagnosed pathologically and/or cytologically, who have failed to receive standard treatment, or who currently do not/or refuse standard treatment, or who are intolerant to standard treatment;
  • Patient must have at least one measurable lesion as defined per RECIST v1.1;
  • Aged between 18 and 75 (including 18 and 75), male and female patients;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score ≤1;
  • Life expectancy ≥ 3 months;
  • The functions of patients' major organs were basically normal, and the laboratory tests performed within 7 days prior to the first administration of study drugmet the following criteria, Patients must not have required a blood transfusion or growth factor support within 14 days before the examination:
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  • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5 × Upper limit of Normal (ULN); Total Bilirubin≤ 1.5×ULN; International Normalized Ratio (INR) ≤1.5; Creatinine ≤ 1.5 × ULN, and Creatinine Clearance Rate (calculated by Cockcroft-Gault formula) ≥ 50 mL/min; Hemoglobin (Hg) ≥ 90g/L; Platelets ≥ 100×10⋀9/L; Absolute Neutrophil Count(ANC) ≥ 1.5×10⋀9/L
  • Fertile women must confirm a negative blood pregnancy test within 7 days prior to the first administration of study drug;All enrolled patients (both male and female) are required to use adequate and effective contraceptive measures throughout the treatment period and within 3 months after the end of treatment;
  • Those who voluntarily participate in the study and sign the written Informed Consent Form upon full informed consent.

Who cannot join

  • Prior treatment with XPO1 inhibitors;
  • Have a history of allergy to any component or excipient of WJ010175 tablets;
  • Patient with a primary malignancy other than the tumor treated in the study within 5 years prior to the first administration of study drug (exceptions include cured malignancies that did not recur within 3 years prior to enrollment;Basal cell and squamous cell carcinoma completely resected;Complete excision of any type of carcinoma in situ, etc.);
  • Received other anti-tumor therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy and other anti-tumor therapies (such as anti-tumor traditional Chinese medicine), within 4 weeks or 5 half-life periods (whichever is longer) prior to the first administration of study drug;Or long-term treatment with potent CYP1A2 inhibitors, potent CYP3A4 inducers and potent CYP3A4 inhibition;
  • Thrombosis or embolism occurred within 6 months prior to the first administration of study drug;
  • Received medium or major surgical treatment within 4 weeks prior to the first administration of study drug, other than diagnostic biopsy ;
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  • Any of the following conditions within 6 months prior to the first administration of study drug: New York Cardiology Association (NYHA) > Grade II cardiac insufficiency, congestive heart failure, severe/unstable angina pectoris (symptoms of resting angina pectoris), myocardial infarction, arrhythmias requiring treatment, uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy;
  • Adverse events and/or complications caused by previous treatment are not relieved to < Level 2 (per NCI-CTCAE V5.0);Any level of hair loss/pigmentation and long-term toxicity caused by other treatment, other than those that the investigator diagnosiss cannot be recovered and do not affect study administration or compliance and patient safety;
  • Patient with central nervous system metastasis or tumors originating in the central nervous system;,
  • Patient with grade ≥ 2 neuropathy (per NCI-CTCAE V5.0);
  • Severe infections requiring antibiotic treatment within 14 days prior to the first administration of study drug ( > CTCAE Grade 2 ), such as severe pneumonia, bacteremia, infection complications requiring hospitalization;
  • Uncontrolled pericardial effusion, pleural effusion or clinically obvious moderate to severe abdominal effusion during screening is defined as meeting the following criteria: having clinical symptoms and detectable thoracic and abdominal effusion during physical examination;Or in the screening process, the thoracoabdominal effusion needs to be punctured pumping liquid and/or intravenously administered;
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Patient has serious psychological or mental abnormalities affecting the compliance of the subjects to participate in the study;
  • With active Hepatitis B, or Hepatitis C, or Human Immunodeficiency Virus positive [HIV (+)] and syphilis antibody (+);Note: Hepatitis B virus surface Antigen (HBsAg) or core antibody (HBcAb) positive should be tested for HBV-DNA, and HBV-DNA should be below the lower limit of the reference range.Patients who are positive for Hepatitis C virus Antibody (HCV Ab) will be tested for HCV RNA and can be enrolled if they are below the upper limit of normal.
  • With Gastrointestinal dysfunction that may affect drug absorption (e.g., intestinal obstruction, inability to swallow tablets, malabsorption syndrome, uncontrollable nausea or vomiting, etc.);
  • Pregnant or lactating women or men who still have reproductive needs;
  • Other conditions that the investigator considers to be ineligible for inclusion, including but not limited to subjects whose body weight is less than ideal and who are expected to be significantly affected by weight change as determined by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

Other trials in China

About this study

Official title: A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of WJ01075 Tablets in Oral Dose Escalation and Expansion in Patients With Advanced Solid Tumors

This is a phase I study to Investigate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJ01075 tablets in patients with advanced malignant solid tumors, including phase Ia (dose escalation phase) and Phase Ib (dose expansion phase,cohort expansion phase).The study includes screening, treatment and follow-up periods.

In phase Ia, accelerated titration (the first two dose groups) and "3 + 3" combination (the subsequent dose group) were used for dose escalation.

In phase Ib, specific dose groups will be selected for dose expansion according to PK(Pharmacokinetics) and safety data of different dose groups in dose escalation phase.It is planned that SMC(Safety Monitoring Committee) will select one or more dose groups based on previous data for cohort expansion studies to further determine RP2D, safety tolerability and initial efficacy.

Being tested
WJ01075

What participants receive

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

  • WJ01075Drug

    Phase Ia: Dose Escalation Accelerated titration (the first two dose groups) and "3 + 3" combination (the subsequent dose group) were used for dose escalation.

    Phase Ib: Dose Expansion and Cohort Expansion The actual dose, dosing schedule (including combination) and indication selection will be evaluated based on the results of existing trials.

Study groups in NCT05470933
Study groupRoleWhat they receive
WJ01075 tabletsExperimentalOnce a week (QW).
Receives: Drug: WJ01075

What is being measured

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

  1. Dose limited toxicity (DLT)

    incidence and severity of Dose limited toxicity(DLT);

    Measured: 3 years

  2. Adverse event (AE)

    incidence and severity of adverse event (AE), Abnormal changes in laboratory and other tests of clinical significance;

    Measured: 3 years

  3. Serious adverse event (SAE)

    incidence and severity of Serious adverse event (SAE);

    Measured: 3 years

  4. Maximum tolerated dose (MTD)

    Maximum tolerated dose (MTD)

    Measured: 2 years

  5. Recommended phase II dose (RP2D)

    Recommended phase II dose (RP2D)

    Measured: 2 years

Secondary outcomes (21)

  1. Objective response rate(ORR)

    Efficacy endpoints: Objective response rate(ORR) per RECIST v1.1

    Measured: 2 years

  2. Duration of response (DOR)

    Efficacy endpoints: Duration of response (DOR) per RECIST v1.1

    Measured: 2 years

  3. Disease control rate (DCR)

    Efficacy endpoints: Disease control rate (DCR) per RECIST v1.1

    Measured: 2 years

  4. Time to response(TTR)

    Efficacy endpoints: Time to response(TTR) per RECIST v1.1

    Measured: 2 years

  5. Progression-free survival (PFS)

    Efficacy endpoints: Progression-free survival (PFS) per RECIST v1.1

    Measured: 2 years

  6. Overall survival (OS)

    Efficacy endpoints: Overall survival (OS) per RECIST v1.1

    Measured: 2 years

  7. Peak time(Tmax)

    Pharmacokinetic (PK) parameter : Peak time(Tmax) after a single dose;

    Measured: 2 years

  8. Maximum plasma concentration (Cmax)

    Pharmacokinetic (PK) parameter : Maximum plasma concentration (Cmax) after a single dose;

    Measured: 2 years

  9. Clearance rate (CL/F)

    Pharmacokinetic (PK) parameter : Clearance rate (CL/F) after a single dose;

    Measured: 2 years

  10. Apparent volume of distribution (Vd/F)

    Pharmacokinetic (PK) parameter : Apparent volume of distribution (Vd/F) after a single dose;

    Measured: 2 years

  11. Area under blood concentration - time curve (AUC)

    Pharmacokinetic (PK) parameter : Area under blood concentration - time curve (AUC) after a single dose;

    Measured: 2 years

  12. Elimination rate constant (λz)

    Pharmacokinetic (PK) parameter : Elimination rate constant (λz) after a single dose;

    Measured: 2 years

  13. Elimination half-life time ( t1/2) and other parameters

    Pharmacokinetic (PK) parameter : Elimination half-life time ( t1/2) and other parameters after a single dose;

    Measured: 2 years

  14. Steady state valley concentration(Cssmin)

    Pharmacokinetic (PK) parameter : Steady state valley concentration(Cssmin) after repeated administration;

    Measured: 2 years

  15. Steady state peak concentration(Cssmax)

    Pharmacokinetic (PK) parameter : Steady state peak concentration(Cssmax) after repeated administration;

    Measured: 2 years

  16. Average steady-state plasma concentration(Css-av)

    Pharmacokinetic (PK) parameter : Average steady-state plasma concentration(Css-av) after repeated administration;

    Measured: 2 years

  17. Elimination half-life time ( t1/2)

    Pharmacokinetic (PK) parameter : Elimination half-life time ( t1/2) after repeated administration;

    Measured: 2 years

  18. Steady state Area under blood concentration - time curve(AUCss)

    Pharmacokinetic (PK) parameter : Steady state Area under blood concentration - time curve(AUCss) after repeated administration;

    Measured: 2 years

  19. Fluctuation coefficient (DF)

    Pharmacokinetic (PK) parameter : Fluctuation coefficient (DF) after repeated administration;

    Measured: 2 years

  20. Steady-state distribution volume(Vss )

    Pharmacokinetic (PK) parameter : Steady-state distribution volume(Vss ) after repeated administration;

    Measured: 2 years

  21. Accumulation coefficient (AR) and other parameters

    Pharmacokinetic (PK) parameter : Accumulation coefficient (AR) and other parameters after repeated administration;

    Measured: 2 years

Timeline

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

  1. First posted22 Jul 2022
  2. Study start23 Aug 2022
  3. Primary completion18 Apr 2023
  4. Study completion18 Apr 2023

Why it stopped: Terminate the study and close the research center based on strategic changes in product development, unrelated to drug safety.

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
Single group
Model description
Single Group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05470933
Sponsor's protocol ID
JS124-001-I
Status last verified
Aug 2023
First submitted
7 Jul 2022
Last updated
1 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing WJ01075 in people with Advanced Solid Tumors, run by Suzhou Junjing BioSciences 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 9 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: stopped early, as of the sponsor's last update on 1 Sep 2023. 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 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?

The study was stopped early (reason given: Terminate the study and close the research center based on strategic changes in product development, unrelated to drug safety.). Results are not available in the source record.

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?

Dose limited toxicity (DLT) (time frame: 3 years). The study lists 5 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 NCT05470933.

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 1 Sep 2023.

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