A Phase 1/2 interventional study of SHR2554+ SHR1701 and SHR-1701 in Relapsed or Refractory Hodgkin Lymphoma, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Chinese PLA General Hospital · Phase 1/2, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
SHR2554: 350mg/day, PO, twice a day. SHR1701: recommended dose from phase I trial, IV, over 30 minutes.
Phase I: 30-150 mg/kg, IV over 30 minutes. Phase II: recommended dose from phase I trial, IV over 30 minutes.
Phase I : Adverse events
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Time frame: 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
Time frame: up to 36 months
Phase II: Objective response rate (ORR)
The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
Time frame: up to 36 months
Phase II: Progression-free survival (PFS)
Time from the date of first administration of the study drug to disease progression or death from any cause.
Time frame: up to 36 months
Phase II: Overal survival
The median overall survival (OS) time is defined as the time from enrollment to the date of death.
Time frame: up to 36 months
Phase II: Duration of response (DOR)
Time from the first recording of CR or PR evidence to disease progression or death from any cause which was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
Time frame: up to 36 months
Phase II: Biomarkers predictive of efficacy and toxicity
Biomarkers such as EZH2, PD-L1 and TGF-β from tumor tissue and peripheral blood will be assessed for their potential in predicting clinical efficacy and toxicity.
Time frame: up to 36 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Chinese PLA General Hospital