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A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy

NCT03941574 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-10-28

No results posted yet for this study

Summary

It is a single-arm, open-label, multicenter, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 monotherapy for the treatment of patients with unresectable or metastatic MSI-H or dMMR solid tumors who have progressed or intolerable after standard therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX10 (3 mg/kg) once every 2 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol, or up to the longest treatment duration-2 years (52 dosing periods) (whichever occurs earlier).

Conditions

  • MSI-H Solid Malignant Tumor

Interventions

DRUG

HLX10

HLX10 developed by our company is sterile intravenous injection, with specification of 100 mg/10 mL/bottle. The main ingredient is 10.0 mg/mL of recombinant humanized anti-PD-1 monoclonal antibody. The excipients include 0.95 mg/mL citric acid (citric acid monohydrate), 4.56 mg/mL sodium citrate (sodium citrate dihydrate), 3.0 mg/mL sodium chloride, 30.0 mg/mL mannitol and 0.20 mg/mL polysorbate 80 (tween 80), with pH of 5.5.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2024-05-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03941574 on ClinicalTrials.gov