Trials / Unknown
UnknownNCT05780307
IMM2520, a PD-L1 and CD47 Bispecific Antibody in Patients With Advanced Solid Tumors
A Phase 1 Clinical Study to Evaluate IMM2520 Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM2520 in subjects with advanced solid tumors.
Detailed description
IMM2520 is administered via intravenous infusion once week of cycle 1- 12 (4 weeks per cycle). The accelerated titration method and the traditional "3+3" method will be adopted to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) in dose-escalation phase. Once the RP2D is determined, Simon's two-stage design will be used to explore for each specific tumor cohort.adenocarcinoma/esophageal cancer, urothelial cancer, and/or others.
Conditions
- Advanced Solid Tumor
- Non-small Cell Lung Cancer
- Small Cell Lung Cancer
- Breast Cancer
- Squamous Cell Cancer of Head and Neck
- Colorectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IMM2520 | IMM2520 will be administered once a week intravenously at Day 1, Day8, Day 15 and Day 22 each cycle for up to 48 weeks. |
Timeline
- Start date
- 2023-03-23
- Primary completion
- 2024-03-10
- Completion
- 2025-10-26
- First posted
- 2023-03-22
- Last updated
- 2023-06-07
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05780307. Inclusion in this directory is not an endorsement.