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

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05900089
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
36.1
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma
Anticipated Study Start Date :
May 30, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR0302 Group A

Drug: SHR0302
SHR0302 will be administered orally as tablet. SHR0302 treatment will be continued until disease progression or intolerant adverse reactions
Experimental: SHR0302 Group B

Drug: SHR0302
SHR0302 will be administered orally as tablet. SHR0302 treatment will be continued until disease progression or intolerant adverse reactions
Experimental: SHR0302 Group C

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

Outcome Measures

Primary Outcome Measures

  1. RP2D [Up to 30 days after the first dose]

    The RP2D is defined as the dose level chosen for phase II study, based on safety, tolerability, efficacy, collected during the dose escalation study of SHR0302.

  2. Incidence and severity of AEs and SAEs [The first dose until 30 days after last dose]

    To evaluate the safety and tolerability of SHR0302 in patients with PTCL in terms of AEs and SAEs as Assessed by CTCAE v5.0

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age ≥ 18;

  2. Pathologically confirmed T or NK cell lymphoma at the enrolling institution;

  3. Measurable disease;

  4. Relapse or refractory disease after at least 1 systemic therapy;

  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 ；

  6. With a life expectancy of ≥12 weeks;

  7. Adequate bone marrow reserve and organ system functions;

  8. Women of Childbearing Potential (WOBCP) must undergo a serum pregnancy test within seven days before the first medication and the results are negative. WOBCP or men and their WOBCP partners should agree to take effective contraceptive measures from the signing of ICF until 180 days after the last dose of the study drug is used;

  9. Willing to provide written informed consent.

Exclusion Criteria:

  1. Patient has undergone an allogeneic stem cell transplant. Or patient had autologous stem cell transplant within 6 months;

  2. Any unsolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia);

  3. Central nervous system (CNS) or leptomeningeal lymphoma;

  4. received any antitumor therapy within 28 days prior to the first drug use, or the first dose was given within five half-lives of the previous antitumor drug, whichever is shorter;

  5. Major surgical procedures were performed within 28 days before the first dose of study treatment, or surgery was planned during the study period;

  6. Diagnosed with any other malignancies ≤5 years prior to the first dose, early tumors cured after radical treatment were evaluated by PI and considered for exclusion or not;

  7. History of psychotropic substance abuse or drug use;

  8. Previous history of allergy to the investigational drug or its excipients;

  9. Severe cardiovascular disease;

  10. Significant impairment of lung function;

  11. Active infections;

  12. Pregnant or lactation;

  13. Known GI disease or GI procedure that could interfere with the oral absorption of oral medications, including not well controlled refractory nausea, vomiting, chronic gastrointestinal disorders, or capsule swallowing difficulties, or prior surgical resection of intestinal segments;

  14. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henan cancer hospital Zhengzhou Henan China

Sponsors and Collaborators

  • Henan Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Henan Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05900089
Other Study ID Numbers:
  • PTCL-IIT-SHR0302
First Posted:
Jun 12, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Jun 12, 2023