A Study of XS-04 in Patients With Relapsed or Refractory Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
About this trial
Evaluation of the safety, tolerability, pharmacokinetics, and preliminary efficacy of XS-04 in patients with relapsed or refractory hematologic malignancies
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participate in the clinical trial and sign the informed consent form (ICF).
Age ≥18 years, ≤75 years, regardless of gender.
Dose escalation phase: Patients with mature B-cell malignant tumors confirmed by histopathology according to the 2017 World Health Organization (WHO) classification, who have failed existing treatments and have no suitable treatment options and have treatment indications.
For indolent B-NHL (follicular lymphoma [FL], marginal zone lymphoma [MZL], and Waldenström macroglobulinemia [WM]), patients must have received at least two lines of systemic therapy, including at least one line of combination therapy containing anti-CD20 antibodies; for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), patients must have received at least two lines of systemic therapy, including BTK inhibitors or BCL-2 inhibitors; for MCL, patients must have received at least two lines of systemic therapy (including anti-CD20 antibodies, BTK inhibitors, etc.); for aggressive B-NHL (DLBCL), patients must have failed or relapsed after at least two lines of systemic therapy and are not suitable for hematopoietic stem cell transplantation.
Disqualifiers
Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma.
Acute promyelocytic leukemia (APL) or BCR-ABL positive AML patients or those with a history of myeloproliferative neoplasms (MPN).
Use of other cytotoxic drugs, investigational drugs, or other antitumor drugs within 14 days or 5 half-lives before the first dose of the study drug (whichever is shorter) (except hydroxycarbamide and leukapheresis). Patients who received tumor immunotherapy, antibody, or peptide antitumor drug treatment within 4 weeks before the first dose of the study drug.
Patients who underwent therapeutic surgery other than diagnostic, biopsy, or drainage procedures within 4 weeks before the first dose of the study drug, or who are expected to undergo major surgery during the study. For patients who underwent drainage procedures (e.g., thoracic, biliary, etc.) and/or placement of drainage tubes within 4 weeks before the study drug, related symptoms/signs must have substantially resolved, and no prophylactic/therapeutic use of antibiotics is required.
Trial design
Design model
Single group
Treatments tested in this trial
XS-04 tablet
DrugEach treatment cycle is 28 days, with continuous oral administration, twice daily.
Treatment groups
168 Participants
are divided into 1 treatment groupGroup A: A multicenter, open-label, single-arm Phase I dose-escalation and dose-expansion clinical studyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
Safety indicators
Time frame
At the end of C1D21(each cycle is 28 days)2
Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D)
Safety indicators and efficacy indicators
Time frame
Up to 24 monthsSecondary outcomes
1
The occurrence of adverse events (AEs) reported in all subjects who received study drug
Safety indicators
Time frame
From enrollment up to 30 days after last dose2
The occurrence of treatment-emergent adverse events (TEAs)
Safety indicators
Time frame
From first dose up to 30 days after last dose3
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Safety indicators
Time frame
Cycle1(28days）4
Pharmacokinetic variables including maximum plasma concentration (Cmin)
Safety indicators
Time frame
Cycle1(28days）Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov