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

Phase 1/2 Unknown 100 enrolled Chinese PLA General Hospital

RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2023-06-14
Primary completion: 2025-06-01
Completion: 2026-06-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Retlirafusp alfa	Protein / enzyme biologic	30 mg/kg	Intravenous
Subject	Retlirafusp alfa	Protein / enzyme biologic	60 mg/kg	Intravenous
Subject	Retlirafusp alfa	Protein / enzyme biologic	90 mg/kg	Intravenous
Subject	Retlirafusp alfa	Protein / enzyme biologic	120 mg/kg	Intravenous
Subject	Retlirafusp alfa	Protein / enzyme biologic	150 mg/kg	Intravenous
Subject	SHR2554	Small molecule	350 mg	Oral

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

Summary

Timeline

Drugs

Indications