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IMM2510 in Advanced Solid Tumors for Solid Tumors
Phase 1
Recruiting
Research Sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 28 days after the first dose of imm2510, all patients included
Awards & highlights
Summary
This trial is a first-in-human, open-label, multi-center, dose escalation phase 1a study followed by cohort expansion phase 1b study to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of IMM2510, a PD-L1 and VEGF bispecific fusion protein, in patients with advanced solid tumors.
Eligible Conditions
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during 28 days after the first dose of imm2510, all patients included
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 28 days after the first dose of imm2510, all patients included
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AEs
Changes in Electrocardiogram
Changes in Laboratory Test Result
+4 moreSecondary study objectives
AUC0-inf
AUC0-tau
AUC0-tlast
+15 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: IMM2510 in Advanced Solid TumorsExperimental Treatment1 Intervention
IMM2510 Phase 1a Dose Escalation: 0.007 mg/kg, 0.03 mg/kg, 0.1 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 6.0 mg/kg, 10 mg/kg, 20 mg/kg, or higher dose, through intravenous administration every 2 weeks up to 52 weeks.
Phase 1b Cohort Expansion: multiple cohorts are planned, including, but not limited to: non-small cell lung cancer, liver cancer, cervical cancer, cholangiocarcinoma, pancreatic cancer and renal cell carcinoma, with at least 12 patients enrolled in each cohort to further explore the safety and efficacy of IMM2510 in different tumors. The dose for expansion is given by intravenous infusion up to 52 weeks.
Find a Location
Who is running the clinical trial?
Zhejiang Cancer HospitalOTHER
331 Previous Clinical Trials
784,267 Total Patients Enrolled
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Lead Sponsor
13 Previous Clinical Trials
1,424 Total Patients Enrolled
Fudan UniversityOTHER
1,185 Previous Clinical Trials
1,629,627 Total Patients Enrolled
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