NCT05076591

IMM2902, a HER2/SIRPα Bispecific MAb-Trap Antibody-receptor Fusion Protein, in Patients with HER2-expressing Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients with HER2-Expressing Advanced Solid Tumors

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a HER2/SIRPα bispecific mAb-Trap antibody-receptor fusion protein, in patients with HER2-expressing advanced solid tumor.

Conditions

• Advanced Solid Tumor
• Advanced Breast Cancer
• Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	IMM2902	a recombinant bispecific monoclonal antibody with high affinity to the dual targets, HER2 and CD47

Timeline

• Start date: 2022-06-20
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-10-13
• Last updated: 2024-10-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study