At a glance
ClinicalIndex Comparison Record- ✓Unresectable or metastatic MSI-H or dMMR malignant solid tumors confirmed histopathologically or cytologically
- ✓Disease progression or intolerable reactions after available standard anti-cancer treatment
- ✓Age 18-75 years at informed consent signing
- ✓At least one measurable lesion by RECIST 1.1 per IRRC assessment
- ✕Prior organ or bone marrow transplantation
- ✕Uncontrollable pleural effusion, pericardial effusion, or ascites
- ✕Active CNS metastasis or carcinomatous meningitis
- ✕Spinal cord compression not radically treatable or unstable
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT03941574Phase 2RecruitingUpdate OverdueUpdated 44mo ago · Completion was 25mo agoA Single-arm, Multi-center, Phase Ⅱ Clinical Study to Evaluate the HLX10 Monotherapy for the Treatment of Unresectable or Metastatic Microsatellite Instability-high (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors That Failed to Respond to Standard Therapy
In Brief
A Phase 2 clinical trial evaluating HLX10 for MSI-H Solid Malignant Tumor. Currently recruiting, targeting 108 participants across 33 sites.
Signals
Detailed 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).
Study Details
Timeline
Interventions
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.