A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With Peripheral T-cell Lymphoma

NCT06173999 | Recruiting Phase 1

• 1 other identifier: SHR2554-201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.

Conditions

Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Safety endpoints: incidence and severity of adverse events (AEs)

  Ib phase

  through study completion, an average of about 6 months

• Overall response rate (ORR)

  II phase

  90 days since the date of first dose

Secondary Outcomes (5)

• Plasma concentration

  Day 1 of cycle 1 to day 1 of cycle 4 (21 days/cycle)

• Progression Free Survival (PFS)

  through study completion, an average of about 6 months

• Overall Survival (OS)

  2 years since the date of first dose

• Duration of response (DOR)

  through study completion, an average of about 6 months

• Incidence and severity of adverse events (AEs)

  through study completion, an average of about 6 months

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: SHR2554/CHOP

Treatment group B

EXPERIMENTAL

Drug: SHR2554/CHOEP

Interventions

SHR2554/CHOP DRUG

SHR2554 with CHOP

Treatment group A

SHR2554/CHOEP DRUG

SHR2554 with CHOEP

Treatment group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18-70 years (inclusive);
• Histologically confirmed peripheral T-cell lymphoma;
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1;
• Life expectancy ≥ 12 weeks;
• Have measurable lesions ;
• The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures.

You may not qualify if:

• Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug;
• Known active HBV or HCV infection;
• History of clinically significant cardiovascular disease;
• History of other malignancies within 5 years;
• Pregnant or lactating women;
• Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

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

Yang Wu

CONTACT

0518-82342973; yang.wu.yw96@hengrui.com

Study Design

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

Model Details: SHR2554 with CHOP/CHOEP.

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: December 22, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CN (1)