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Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma

NCT05900089 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-06-12

No results posted yet for this study

Summary

This is a non-randomized, open-label, Phase 1b clinical study to evaluate the safety, tolerability and anti-tumor efficacy of SHR0302 as monotherapy in patients with relapsed/refractory peripheral T/NK cell lymphoma. Around 7-18 patients will be subsequently enrolled into 3 different dose ascending cohorts. Additional 12-18 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts.

Conditions

  • Peripheral T Cell Lymphoma

Interventions

DRUG

SHR0302

SHR0302 will be administered orally as tablet. SHR0302 treatment will be continued until disease progression or intolerant adverse reactions

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2025-11-01
Completion
2026-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05900089 on ClinicalTrials.gov