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

Primary Purpose

Peripheral T Cell Lymphoma

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR0302
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18; Pathologically confirmed T or NK cell lymphoma at the enrolling institution; Measurable disease; Relapse or refractory disease after at least 1 systemic therapy; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 ; With a life expectancy of ≥12 weeks; Adequate bone marrow reserve and organ system functions; 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; Willing to provide written informed consent. Exclusion Criteria: Patient has undergone an allogeneic stem cell transplant. Or patient had autologous stem cell transplant within 6 months; Any unsolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia); Central nervous system (CNS) or leptomeningeal lymphoma; 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; Major surgical procedures were performed within 28 days before the first dose of study treatment, or surgery was planned during the study period; 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; History of psychotropic substance abuse or drug use; Previous history of allergy to the investigational drug or its excipients; Severe cardiovascular disease; Significant impairment of lung function; Active infections; Pregnant or lactation; 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; 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.

Sites / Locations

  • Henan cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SHR0302 Group A

SHR0302 Group B

SHR0302 Group C

Arm Description

Outcomes

Primary Outcome Measures

RP2D
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.
Incidence and severity of AEs and SAEs
To evaluate the safety and tolerability of SHR0302 in patients with PTCL in terms of AEs and SAEs as Assessed by CTCAE v5.0

Secondary Outcome Measures

Full Information

First Posted
June 2, 2023
Last Updated
June 2, 2023
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05900089
Brief Title
Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma
Official Title
Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR0302 Group A
Arm Type
Experimental
Arm Title
SHR0302 Group B
Arm Type
Experimental
Arm Title
SHR0302 Group C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
SHR0302 will be administered orally as tablet. SHR0302 treatment will be continued until disease progression or intolerant adverse reactions
Primary Outcome Measure Information:
Title
RP2D
Description
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.
Time Frame
Up to 30 days after the first dose
Title
Incidence and severity of AEs and SAEs
Description
To evaluate the safety and tolerability of SHR0302 in patients with PTCL in terms of AEs and SAEs as Assessed by CTCAE v5.0
Time Frame
The first dose until 30 days after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18; Pathologically confirmed T or NK cell lymphoma at the enrolling institution; Measurable disease; Relapse or refractory disease after at least 1 systemic therapy; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 ; With a life expectancy of ≥12 weeks; Adequate bone marrow reserve and organ system functions; 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; Willing to provide written informed consent. Exclusion Criteria: Patient has undergone an allogeneic stem cell transplant. Or patient had autologous stem cell transplant within 6 months; Any unsolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia); Central nervous system (CNS) or leptomeningeal lymphoma; 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; Major surgical procedures were performed within 28 days before the first dose of study treatment, or surgery was planned during the study period; 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; History of psychotropic substance abuse or drug use; Previous history of allergy to the investigational drug or its excipients; Severe cardiovascular disease; Significant impairment of lung function; Active infections; Pregnant or lactation; 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keshu Zhou, Dr
Phone
+86-13674902391
Email
drzhouks77@163.com
Facility Information:
Facility Name
Henan cancer hospital
City
Zhengzhou
State/Province
Henan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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