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

NCT05900089 | Not Yet Recruiting Phase 1

• 1 other identifier: PTCL-IIT-SHR0302
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 30 days after the first dose

• 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

  The first dose until 30 days after last dose

Study Arms (3)

SHR0302 Group A

EXPERIMENTAL

Drug: SHR0302

SHR0302 Group B

EXPERIMENTAL

Drug: SHR0302

SHR0302 Group C

EXPERIMENTAL

Drug: SHR0302

Interventions

SHR0302 DRUG

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

SHR0302 Group A; SHR0302 Group B; SHR0302 Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Keshu Zhou, Dr

CONTACT

+86-13674902391; drzhouks77@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: May 30, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 12, 2023

Record last verified: 2023-05

Locations

CN (1)