search
Back to results

SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma

Primary Purpose

Relapsed or Refractory Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR2554+ SHR1701
SHR-1701
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Hodgkin Lymphoma

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL). 12 to 75 years of age. ECOG performance of less than 2. Life expectancy of at least 3 months. Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria. Subjects must have received two or more lines of previous therapy, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Previous treatment with anti-PD-1/PD-L1 antibodies or cytotoxic T lymphocyte associated antigen 4 (CTLA-4) inhibitors are allowed, and must be off therapy for at least 4 weeks. Subjects must have adequate marrow, live, renal and heart functions. Exclusion Criteria: Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month . Prior organ allograft. Women who are pregnant or breastfeeding. Women with a positive pregnancy test on enrollment or prior to investigational product administration. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Sites / Locations

  • Han wei dongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase I/ II: SHR1701

Phase II: SHR2554+ SHR170

Arm Description

Phase I: 30-150 mg/kg, IV over 30 minutes, every 3 weeks. Phase II: recommended dose from phase I trial, IV over 30 minutes, every 3 weeks.

SHR2554: 350mg/day, PO, twice a day, every 3 weeks. SHR1701: recommended dose from phase I trial, IV over 30 minutes, every 3 weeks.

Outcomes

Primary Outcome Measures

Phase I : Adverse events
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Phase I/ II: Complete response rate (CRR)
CRR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects

Secondary Outcome Measures

Phase II: Objective response rate (ORR)
The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
Phase II: Progression-free survival (PFS)
Time from the date of first administration of the study drug to disease progression or death from any cause.
Phase II: Overal survival
The median overall survival (OS) time is defined as the time from enrollment to the date of death.
Phase II: Duration of response (DOR)
Time from the first recording of CR or PR evidence to disease progression or death from any cause which was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).

Full Information

First Posted
May 31, 2023
Last Updated
June 14, 2023
Sponsor
Chinese PLA General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05896046
Brief Title
SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma
Official Title
An Open-Label Phase I/II Study of SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General 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 an open-label, phase I/II dose escalation and expansion trial. The primary objective of dose escalation phase I study is to evaluate the safety and feasibility of SHR1701 in patients with relapsed or refractory classical Hodgkin Lymphoma. The primary objective of open-label, randomized, phase II study is to assess the antitumor effect of SHR1701 alone or in combination with SHR2554 in patients with relapsed or refractory classical Hodgkin Lymphoma.
Detailed Description
In phase I study, patients received intravenous SHR1701 30-150 mg/kg every 3 weeks. Sequential patient groups received the following doses of SHR1701: 30 mg/kg, 60 mg/kg, 90 mg/kg, 120 mg/kg, or 150 mg/kg in a 3+3 design with the intention of determining the recommended dose for phase 2. Toxicities are graded according to the Common Terminology Criteria for Adverse Events, version 5.0. In phase II expansion study, based on the recommended dose of SHR1701 from phase I study, patients are treated with SHR1701 alone if CR rate is satisfactory, or randomized to SHR1701 monotherapy group or SHR2554 plus SHR1701 combination group to assess the clinical efficacy of SHR2554 plus SHR1701 combination therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase I/ II: SHR1701
Arm Type
Experimental
Arm Description
Phase I: 30-150 mg/kg, IV over 30 minutes, every 3 weeks. Phase II: recommended dose from phase I trial, IV over 30 minutes, every 3 weeks.
Arm Title
Phase II: SHR2554+ SHR170
Arm Type
Experimental
Arm Description
SHR2554: 350mg/day, PO, twice a day, every 3 weeks. SHR1701: recommended dose from phase I trial, IV over 30 minutes, every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
SHR2554+ SHR1701
Intervention Description
SHR2554: 350mg/day, PO, twice a day. SHR1701: recommended dose from phase I trial, IV, over 30 minutes.
Intervention Type
Drug
Intervention Name(s)
SHR-1701
Intervention Description
Phase I: 30-150 mg/kg, IV over 30 minutes. Phase II: recommended dose from phase I trial, IV over 30 minutes.
Primary Outcome Measure Information:
Title
Phase I : Adverse events
Description
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Time Frame
Up to 90 days after the last dose of study drugs
Title
Phase I/ II: Complete response rate (CRR)
Description
CRR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Phase II: Objective response rate (ORR)
Description
The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
Time Frame
up to 36 months
Title
Phase II: Progression-free survival (PFS)
Description
Time from the date of first administration of the study drug to disease progression or death from any cause.
Time Frame
up to 36 months
Title
Phase II: Overal survival
Description
The median overall survival (OS) time is defined as the time from enrollment to the date of death.
Time Frame
up to 36 months
Title
Phase II: Duration of response (DOR)
Description
Time from the first recording of CR or PR evidence to disease progression or death from any cause which was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
Time Frame
up to 36 months
Other Pre-specified Outcome Measures:
Title
Phase II: Biomarkers predictive of efficacy and toxicity
Description
Biomarkers such as EZH2, PD-L1 and TGF-β from tumor tissue and peripheral blood will be assessed for their potential in predicting clinical efficacy and toxicity.
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL). 12 to 75 years of age. ECOG performance of less than 2. Life expectancy of at least 3 months. Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria. Subjects must have received two or more lines of previous therapy, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Previous treatment with anti-PD-1/PD-L1 antibodies or cytotoxic T lymphocyte associated antigen 4 (CTLA-4) inhibitors are allowed, and must be off therapy for at least 4 weeks. Subjects must have adequate marrow, live, renal and heart functions. Exclusion Criteria: Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month . Prior organ allograft. Women who are pregnant or breastfeeding. Women with a positive pregnancy test on enrollment or prior to investigational product administration. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Facility Information:
Facility Name
Han wei dong
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han W dong
Phone
+861055499341
Email
hanwdrsw@sina.com

12. IPD Sharing Statement

Learn more about this trial

SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma

We'll reach out to this number within 24 hrs