Actively Recruiting
A Phase I Trial to Evaluate the Tolerability, Pharmacokinetics and Preliminary Efficacy of XS-04 in Patients with Hematologic Malignancies
Led by NovaOnco Therapeutics Co., Ltd. · Updated on 2025-03-04
168
Participants Needed
4
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying XS-04 tablets in patients with relapsed or refractory blood cancers, including B-cell lymphoma, acute myeloid leukemia, and myelodysplastic syndrome. The main goal is to evaluate the safety and tolerability of XS-04, determine the highest dose patients can handle, and find the recommended dose for future studies. The trial also looks at how the body processes the drug and explores early signs of how well the treatment works, including how food affects drug levels and the relationship between drug exposure and biological markers. This is a Phase I, open-label study with a dose escalation phase and a dose expansion phase. In the dose escalation phase, patients receive increasing doses of XS-04 tablets orally twice daily in 28-day cycles, starting with a smaller initial dose to observe drug behavior. Dose levels range from 1 mg up to 160 mg per day, with adjustments allowed based on safety and drug levels. Following this, selected doses will be studied further in the dose expansion phase with specific patient groups. Treatment is continuous throughout each cycle. Participants will attend visits for safety monitoring, laboratory tests, and assessments throughout the study. Researchers will track adverse events, measure drug levels in blood after single and multiple doses, and evaluate treatment impact through biomarker analysis. Bone marrow samples and imaging will be used to assess disease status. Participants will be followed for up to 24 months to monitor side effects and determine the maximum tolerated dose and recommended Phase II dose. The study ensures careful monitoring of health and treatment effects during and after the trial.
CONDITIONS
Brief Title
A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Voluntarily agree to participate and sign informed consent
- For dose escalation: patients with mature B-cell malignant tumors confirmed by 2017 WHO classification, relapsed or refractory after prior treatments
- For dose expansion: patients with B-cell lymphoma or myeloid tumors confirmed by WHO classification, including DLBCL, other B-cell lymphomas, AML, or MDS
- Specific prior treatment requirements depending on lymphoma subtype (e.g., at least two lines including anti-CD20 antibodies or BTK/BCL-2 inhibitors)
- At least one measurable lesion for B-cell lymphoma patients
- Willing to undergo bone marrow aspiration and/or biopsy
- ECOG performance status 0-1 (dose escalation) or 0-2 (dose expansion)
- Expected survival of at least 3 months
- Adequate bone marrow and organ function as defined by lab values before first dose
- Female patients must have negative pregnancy test and agree to use effective contraception
- Ability to comply with study procedures and visits
You will not qualify if you...
- Diagnosis of Burkitt lymphoma/leukemia, plasma cell myeloma, or plasmablastic lymphoma
- Acute promyelocytic leukemia or BCR-ABL positive AML, or history of myeloproliferative neoplasms
- Use of other antitumor drugs within 14 days or 5 half-lives before first dose, except hydroxycarbamide or leukapheresis
- Tumor immunotherapy, antibody, or peptide treatments within 4 weeks before first dose
- Major surgery within 4 weeks before first dose or planned during study
- Systemic radiotherapy within 4 weeks before first dose
- Unresolved toxic reactions from prior treatments beyond defined severity
- Recent stem cell transplantation or adoptive immune cell therapy within specified timeframes
- Lymphoma or leukemia involving the central nervous system
- Severe gastrointestinal diseases affecting drug absorption or control
- Active ocular lesions unless treated
- Unstable or active cardiovascular or cerebrovascular diseases
- History of interstitial lung disease, pulmonary fibrosis, or active pneumonia
- Congenital immune deficiencies or active autoimmune diseases
- Coagulopathy or current anticoagulant use
- Severe allergies or allergy to study drug components
- Uncontrolled infections or positive for certain viral infections
- Other primary malignancies except certain cured skin cancers
- Use of systemic immunosuppressants or corticosteroids above specified doses
- Use of strong CYP3A inhibitors or inducers within 2 weeks before first dose
- Pregnant or breastfeeding women
- Any other severe or uncontrolled disease or lab abnormality deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants take XS-04 tablets orally twice daily in repeated 28-day cycles. The dose may be adjusted based on safety, pharmacokinetic, and efficacy data.
Repeated visits during each 28-day treatment cycle
Duration - 30 days after last dose
Participants are monitored for adverse events and safety for 30 days after the last dose of XS-04.
1 to 2 visits after treatment ends
Trial Site Locations
Total: 4 locations
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangdong, China
Not Yet Recruiting
3
Affiliated Hospital of Hebei University
Hebei, China
Actively Recruiting
4
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, China
Not Yet Recruiting
Research Team
J
Jun Zhu, MD
Y
Yuqin Song, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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