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Solid TumorPhase 1/2NCT06531486

A Study of XS-02 Capsules in Patients With Advanced Solid Tumors

A Phase 1/2 study testing XS-02 capsules in people with Solid Tumor and Ovarian Cancer, run by NovaOnco Therapeutics Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

A study to evaluate the safety, tolerability, Pharmacokinetics(pk), and efficacy of XS-02 capsules in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor, Ovarian Cancer, Breast Cancer
What is being tested?
XS-02 capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
No sites listed yet
Study dates
29 Jul 2024to 30 Aug 2027
Phase
Phase 1/2

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

  • Volunteer to participate in clinical trials and sign an informed consent form (ICF).
  • Age ≥18 years old, ≤75 years old, regardless of gender.
  • Patients with locally advanced or metastatic solid tumors diagnosed histologically or cytologically have no standard treatment options or have failed standard treatment or are unable to tolerate standard treatment. Phase II dose expansion/Optimal dose selection phase enrolls advanced ovarian cancer and other advanced entities a tumor patient.
  • The phase I dose escalation phase has at least one evaluable lesion and the phase II dose expansion/optimal dose selection phase has at least one measurable lesion (based on RECIST V1.1). For patients who have previously received radiation therapy, a radiation-treated lesion may be considered a target lesion if the lesion can be measured according to RECIST V1.1 and there is objective evidence of significant progression after radiation therapy.
  • The Eastern Cooperative Oncology Group (ECOG) scored 0-1.
  • The expected survival time is ≥3 months.
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  • Routine blood tests before first dosing must be within the following range (no blood transfusion or use of drugs that assist in raising white blood cells, platelets, hemoglobin, such as cytokines or erythropoietin, etc., for at least 7 days prior to first dosing)
  • Hemoglobin (HB) ≥90 g/L.
  • Platelet (PLT) count ≥100×109/L or ≥5.6 mmol/L.
  • Absolute count of neutrophils (ANC) ≥1.5×109/L.
  • Has proper organ function
  • Female subjects of reproductive age in the screening period had negative serological pregnancy test results within 7 days prior to the first dosing. The subjects also agreed to use a reliable method of contraception for 3 months from signing the informed consent to the last dosing. Including but not limited to: forbidden Sex, male vasectomy, female sterilization, effective IUD, condoms, effective contraceptive drugs.
  • Patients were able to comply with the visits required by the study procedure and protocol.
  • Admission criteria specific to Stage II dose expansion/Optimal dose Selection stage ovarian cancer:
  • Histologically confirmed and documented advanced recurrent epithelial ovarian cancer (high-grade serous ovarian cancer), fallopian tube cancer, and primary peritoneal cancer.
  • For platinum-resistant diseases, there must be evidence of disease progression within 6 months of the most recent platinum-containing treatment, calculated from the date of the last platinum treatment dose. Platinum-refractory patients were not admitted (platinum-refractory was defined as during or after chemotherapy containing platinum-containing chemotherapy)Progress within 4 weeks.
  • Have previously received at least 1 standard line of treatment.

Who cannot join

  • Chemotherapy, small molecule targeted therapy, endocrine therapy and traditional Chinese medicine with anti-tumor indications were received within 2 weeks prior to the first dose. Received tumor immunotherapy, antibodies, polypeptide antitumor, or other investigational drugs within 4 weeks prior to initial administration.
  • Patients who had undergone therapeutic surgery other than diagnosis, biopsy, drainage, or radical radiotherapy within 4 weeks prior to initial dosing, or who expected to undergo major surgery during the study period. Had received palliative radiotherapy within 2 weeks prior to the first dose, or had used radiopharma (strontium, samarium, etc.) within 56 days prior to the first dose.
  • The toxicity of previous antitumor therapy has not recovered (> NCI-CTCAE 5.0 grade 1),alopecia, pigmentation, or other toxicity that the investigators assessed had become chronic and did not affect the safety of the investigational medication returned to NCI-CTCAE 5.0 level 2 or below.
  • Imaging (Computed Tomography(CT) or magnetic resonance imaging(MRI)) shows that the tumor has invaded large blood vessels (such as aorta, pulmonary artery, pulmonary vein, vena cava, etc.) or is at risk of bleeding (such as esophageal and gastric varices).
  • inflammatory breast cancer
  • There is clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to administration).
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  • Patients with central nervous system metastasis who meet any of the following conditions:
  • need to undergo local treatment (surgery, radiation or other);
  • Patients who require steroid hormones, anticonvulsants, or other dehydration treatment;
  • Only enrollment is allowed Stable symptoms, imaging assessment (imaging evaluation of brain metastases within 4 weeks prior to enrollmentlesions that have not progressed) and do not require treatment
  • Patients with difficulty swallowing, or a history of severe gastrointestinal disease (e.g. active inflammatory bowel disease, gastrointestinal perforation) and related symptoms that cannot be reasonably controlled; Or have a gastrointestinal disorder (e.g., Crohn's disease, ulcerative colitis, intestinal obstruction, short bowel syndrome) or other malabsorption conditions that affect drug absorption.
  • Have active or unstable cardiovascular disease
  • Bacterial, fungal, or viral infections requiring intravenous antibiotics/antivirals or hospitalization were investigated within 2 weeks prior to initial drug administration.
  • People who have a history of prior severe allergies, or are allergic to any active or inactive ingredient of the investigatory drug.
  • Known acute or active hepatitis B (hepatitis B virus（HBV） surface antigen positive with HBV deoxyribonucleic acid（DNA）≥500 IU/mL), hepatitis C virus infection (HCV Ribonucleic Acid（RNA） exceeding the normal range), syphilis infection, and human immunodeficiency virus (HIV) infection.
  • Other primary malignancies have been diagnosed within the previous five years (the following conditions can be included: cured and completely resected basal and squamous cell skin cancers, completely resected cancers of any type in situ).
  • Use within 2 weeks prior to first administration, or expect to use a Cytochrome P450 enzyme(CYP3A) booster or strong inducer during study drug administration.
  • Use within 2 weeks prior to first administration, or expect to use any drug known to prolong the corrected QT(QTc) interval during study drug administration.
  • The ATR/CHK1 pathway has been treated in the past.
  • Had a bone marrow transplant or had extensive radiation therapy on more than 25% of the bone marrow in the 8 weeks prior to initial dosing.
  • A history of blood clotting disorders; Anticoagulant or antiplatelet therapy (oral aspirin dose ≤100 mg/d and subcutaneous injection of low molecular weight heparin for prevention of deep vein thrombosis) is required.
  • Pregnant and lactating women.
  • According to the judgment of the investigator, any other serious or uncontrolled acute or chronic diseases or abnormal laboratory tests or other reasons are not suitable for participation in this clinical study.

About this study

Official title: A Multicenter, Open Label, Single-arm Phase I/II Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of XS-02 Capsules in Patients With Advanced Solid Tumors

A study to evaluate the safety, tolerability, Pharmacokinetics(pk), and efficacy of XS-02 capsules in patients with advanced solid tumors.

Read the detailed description

This is a multicenter, open label, single-arm Phase I/II dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of XS-02 capsules in patients with advanced solid tumors.

Being tested
XS-02 capsules
Keywords
XS-02, Cell cycle checkpoint kinase 1（CHK1), Solid tumor, ovarian cancer
Medical subject headings
Ovarian Neoplasms, Breast Neoplasms, Endometrial Neoplasms

What participants receive

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

  • XS-02 capsulesOther

    Upon completion of all screening visits, eligible patients will be treated with XS-02 capsules at the appropriate dose.

Study groups in NCT06531486
Study groupRoleWhat they receive
Phase I dose escalation/Phase II dose expansionExperimentalExperimental: XS-02 Dosage form:capsule Specification: 5mg，25mg Dose: Phase I dose escalation, orally, once daily, the administration schedule (including dose,administration frequency/interval, administration cycle, etc.) can be adjusted according to the experimental data. Phase II Dose Expansion/Optimal Dose selection, will be determined based on the Phase I dose escalation results. Method of administration: Oral
Receives: Other: XS-02 capsules

What is being measured

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

  1. Occurrence of Dose Limiting Toxicity (DLT) (DLT observation period).(phase I)

    DLT is defined as a dose-limiting toxic event that occurs during DLT observation.

    Measured: from first dose up to 31 days

  2. Maximum tolerated dose (MTD) and/or Recommended Phase II Dose(RP2D).(phase I)

    MTD is defined as the maximum tolerated dose。RP2D is defined as the recommended dose for Phase II clinical studies

    Measured: Time Frame: from first dose to phase I completion, an average of 1.5 years

  3. Objective Response Rate（ORR）(phase II)

    ORR is defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as evaluated according to RECIST version 1.1.

    Measured: Through study completion, an average of 3 years

Secondary outcomes (14)

  1. the incidence and severity of adverse events, serious adverse events, deaths, and safety screening abnormalities(phase I/II)

    According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE) version 5.0 evaluates the incidence and severity of adverse events, serious adverse events, deaths, and safety screening abnormalities (such as laboratory tests, vital signs, physical examinations, electrocardiograms, ECOG, etc.). Proportion of patients undergoing dose adjustment or discontinuation due to drug toxicity.

    Measured: From enrollment up to 30 days after last dose

  2. Pharmacokinetics(PK) parameters(phase I/II)

    Area under the concentration-time curve from time 0 (pre-dose) to the last measurable time of concentration(AUC0-t)

    Measured: up to 12 weeks

  3. PK parameters(phase I/II)

    Area under the concentration-time curve from time 0 (pre-dose) to infinity(AUC0-∞)

    Measured: up to 12 weeks

  4. PK parameters(phase I/II)

    Area under the plasma drug concentration-time curve over a dosing interval at steady state(AUCtau)

    Measured: up to 12 weeks

  5. PK parameters(phase I/II)

    Maximum plasma concentration(Cmax)

    Measured: up to 12 weeks

  6. PK parameters(phase I/II)

    Time to maximum plasma concentration(Tmax)

    Measured: up to 12 weeks

  7. PK parameters(phase I/II)

    half-life(t1/2)

    Measured: up to 12 weeks

  8. Disease Control Rate(DCR)(phase I/II)

    DCR is defined as the proportion of patients with confirmed Complete Response(CR), Partial Response(PR), and Stable Disease(SD) based on the Response Evaluation Criteria in Solid Tumors Version 1.1(RECISIT V1.1) evaluation.

    Measured: Through study completion, an average of 3 years

  9. （Clinical Benefit Rate(CBR)(phase I/II)

    CBR was defined as the proportion of patients with CR, PR, and SD lasting at least 24 weeks, as evaluated according to RECIST version 1.1.

    Measured: Through study completion, an average of 3 years

  10. Duration of Response（DOR）(phase I/II)

    DOR is defined as the time from the date of first documented response (which is subsequently confirmed) until progression per RECIST V1.1 criteria or death due to any cause

    Measured: Through study completion, an average of 3 years

  11. Time to Response（TTR）(phase I/II)

    TTR is defined as the time from the first dose to the first confirmed PR or CR evaluated according to RECIST version 1.1.

    Measured: Through study completion, an average of 3 years

  12. Progression Free Survival（PFS）(phase I/II)

    PFS is defined as the time until disease progression or death of the first dose, whichever occurs first.

    Measured: Through study completion, an average of 3 years

  13. Overall Survival（OS）(phase I/II)

    OS is defined as the time from the first use of the study drug until death from any cause.

    Measured: Through study completion, an average of 3 years

  14. Objective Response Rate（ORR）(phase I)

    ORR is defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as evaluated according to RECIST version 1.1.

    Measured: from first dose to phase I completion, an average of 1.5 years

Timeline

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

  1. First posted1 Aug 2024
  2. Study start29 Jul 2024 (estimated)
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Aug 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06531486
Sponsor's protocol ID
XS-02-I101
Status last verified
Jul 2024
First submitted
28 May 2024
Last updated
1 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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