NCT05896046

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed or Refractory Hodgkin Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-14
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2023-06-09
• Last updated: 2023-06-15

Locations

1 site across 1 country: China