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RECRUITING
NCT05896046
PHASE1/PHASE2

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

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-06-14

Completion Date

2026-06-01

Last Updated

2023-06-15

Healthy Volunteers

No

Interventions

DRUG

SHR2554+ SHR1701

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

DRUG

SHR-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