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XS-04

Phase 1

B-cell Lymphoma | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Mar 4, 2025

Target and mechanism

ModalitySmall molecule

Also known as XS-04 tablet

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment168

FDA Designations

No designations recorded

Clinical trial landscape

XS-04 · 1 trial · 3 indications

Phase 1 1
NCT06820268A Study of XS-04 in Patients with Relapsed or Refractory Hematologic MalignanciesB-cell Lymphoma
RECRUITING168 Analytics
PHASE1RECRUITING
A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies
B-cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

The occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
At the end of C1D21(each cycle is 28 days)

Safety indicators

Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D)
Up to 24 months

Safety indicators and efficacy indicators

Secondary Endpoints

The occurrence of adverse events (AEs) reported in all subjects who received study drug
From enrollment up to 30 days after last dose
The occurrence of treatment-emergent adverse events (TEAs)
From first dose up to 30 days after last dose
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Cycle1(28days)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A multicenter, open-label, single-arm Phase I dose-escalation and dose-expansion clinical studyEXPERIMENTALFor drugs, use the generic name and include dosage form, dosage, frequency, and duration. Note: Group description not yet entered.\] XS-04 tablet specifications: 0.5 mg, 5 mg, 20 mg. Dose escalation phase: 1 mg, 3 mg, 10 mg, 20 mg, 40 mg, 80 mg, 120 mg, 160 mg/day (dose adjustment allowed based on actual escalation situation); Cycle 0 phase, oral administration once (dose is half of the total daily dose for the respective dose group), observe for two days (based on the PK results of the first 1-2 dose groups, decide whether the remaining dose groups need Cycle 0 phase); thereafter Cycle 1-N phase, each 28 days is one treatment cycle, continuous administration, two times daily. Dose regimen adjustments are allowed based on PK, safety, and efficacy data in this trial. Dose expansion phase: Based on the results of the dose escalation phase, cohort one and cohort two are planned to use the RP2D dose, cohort three safety lead-in phase is

Interventions

NameTypeDescription
XS-04 tabletDRUGEach treatment cycle is 28 days, with continuous oral administration, twice daily.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria Patients must meet all of the following conditions to be enrolled: * 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 co...

Countries:China
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Competitive Landscape -Cutaneous T-Cell Lymphoma 3 trials (matched to "B-cell Lymphoma")

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Frequently asked questions about XS-04

What is XS-04 used for?

XS-04 is an investigational small molecule being developed for the treatment of B-cell Lymphoma. It is also being studied in patients with relapsed or refractory hematologic malignancies, including Acute Myeloid Leukemia and Myelodysplastic Syndrome. The drug is currently in Phase 1 clinical development.

Who makes XS-04?

XS-04 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting a Phase 1 clinical trial of XS-04 in patients with relapsed or refractory hematologic malignancies.

What phase is XS-04 in?

XS-04 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently recruiting participants to evaluate the drug in patients with B-cell Lymphoma and other hematologic malignancies.

What clinical trials is XS-04 in?

XS-04 is being studied in a Phase 1 clinical trial with the identifier NCT06820268. This trial is titled 'A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies' and is currently recruiting participants in China. The study is an uncontrolled, open-label trial with an enrollment target of 168 patients.

Is XS-04 the same as XS-04 tablet?

Yes, XS-04 is also known as XS-04 tablet. The drug is being developed as an oral tablet formulation for the treatment of B-cell Lymphoma and other hematologic malignancies.

What conditions does the XS-04 clinical trial cover?

The Phase 1 clinical trial of XS-04 (NCT06820268) is studying the drug in patients with B-cell Lymphoma, Acute Myeloid Leukemia, and Myelodysplastic Syndrome. The trial is enrolling adults aged 18 years and older of all sexes in China.