NCT05396339

A Clinical Trial to Evaluate the Effect of IAE0972 in Patients With Advanced Malignant Solid Tumors.

A Phase I/IIa Clinical Trial to Evaluate the Safety,Tolerability,Pharmacokinetics and Preliminary Effectiveness of IAE0972 in Patients With Advanced Malignant Solid Tumors.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/IIa Clinical Trial to Evaluate the Safety,Tolerability,Pharmacokinetics and Preliminary Effectiveness of IAE0972 in Patients With Advanced Malignant Solid Tumors.

Detailed description

The study includes three phases: dose escalation (Phase Ia), dose extension (Phase Ib), and clinical exploration (Phase IIa).First, the Phase Ia dose escalation will be carried out. After finishing the Phase 1a dose escalation, the Phase Ib dose extension study can be carried out in the MTD dose which is obtained from Phase 1a . After Phase Ia \&1b are completed and RP2D is obtained, Phase IIa clinical exploratory research can be carried out.

Conditions

• Advanced Malignant Solid Tumor

Interventions

Type	Name	Description
DRUG	IAE0972	IAE0972 is an investigational product

Timeline

• Start date: 2022-06-24
• Primary completion: 2024-05-30
• Completion: 2024-11-30
• First posted: 2022-05-31
• Last updated: 2023-07-19

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study