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

NCT05896046 | Recruiting Phase 1

• 1 other identifier: CHN-PLAGH-BT-079
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed or Refractory Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Phase I : Adverse events

  Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

  Up to 90 days after the last dose of study drugs

• 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

  up to 36 months

Secondary Outcomes (4)

• Phase II: Objective response rate (ORR)

  up to 36 months

• Phase II: Progression-free survival (PFS)

  up to 36 months

• Phase II: Overal survival

  up to 36 months

• Phase II: Duration of response (DOR)

  up to 36 months

Other Outcomes (1)

• Phase II: Biomarkers predictive of efficacy and toxicity

  up to 36 months

Study Arms (2)

Phase I/ II: SHR1701

EXPERIMENTAL

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.

Drug: SHR-1701

Phase II: SHR2554+ SHR170

EXPERIMENTAL

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

Drug: SHR2554+ SHR1701

Interventions

SHR2554+ SHR1701 DRUG

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

Phase II: SHR2554+ SHR170

SHR-1701 DRUG

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

Phase I/ II: SHR1701

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Han wei dong

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Hodgkin Disease

Interventions

SHR-1701

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: June 14, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

CN (1)