RecruitingPhase 1Phase 2NCT05896046

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

An Open-Label Phase I/II Study of SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma


Sponsor

Chinese PLA General Hospital

Enrollment

100 participants

Start Date

Jun 14, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two experimental drugs — SHR1701 (an immune checkpoint blocker) and SHR2554 (an EZH2 inhibitor) — alone or together for people with Hodgkin lymphoma that has come back or stopped responding to treatment. **You may be eligible if...** - You have confirmed Hodgkin lymphoma that has relapsed or is no longer responding to treatment - You are between 12 and 75 years old - You have had at least two previous rounds of treatment and have been off treatment for at least 4 weeks - You are generally well enough to care for yourself (good performance status) - You have at least one measurable tumor - Your bone marrow, liver, kidneys, and heart are functioning adequately **You may NOT be eligible if...** - You have an autoimmune disease or need steroid/immune-suppressing medications - You have uncontrolled serious medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR2554+ SHR1701

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

DRUGSHR-1701

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


Locations(1)

Han wei dong

Beijing, Beijing Municipality, China

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NCT05896046


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