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

NCT06531486 | Not Yet Recruiting Phase 1

• 1 other identifier: XS-02-I101
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Solid Tumor; Ovarian Cancer; Breast Cancer; Endometrial Cancer

Keywords

XS-02; Cell cycle checkpoint kinase 1（CHK1); Solid tumor; ovarian cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  from first dose up to 31 days

• 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

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

• 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.

  Through study completion, an average of 3 years

Secondary Outcomes (14)

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

  From enrollment up to 30 days after last dose

• Pharmacokinetics(PK) parameters(phase I/II)

  up to 12 weeks

• PK parameters(phase I/II)

  up to 12 weeks

• PK parameters(phase I/II)

  up to 12 weeks

• PK parameters(phase I/II)

  up to 12 weeks

Study Arms (1)

Phase I dose escalation/Phase II dose expansion

EXPERIMENTAL

Experimental: 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

Other: XS-02 capsules

Interventions

XS-02 capsules OTHER

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

Phase I dose escalation/Phase II dose expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• NovaOnco Therapeutics Co., Ltd.: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Uterine Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: August 1, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share