NCT05396391

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients With Advanced Malignant Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (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 Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant 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，the Phase Ib dose extension study can be carried out in the MTD dose which can be achieved from Phase 1a. After Phase Ia \& Ib are completed and RP2D is obtained, Phase IIa clinical exploratory research can be carried out.

Conditions

• Advanced Malignant Tumors

Interventions

Type	Name	Description
DRUG	IAP0971	IAP0971 should be subcutaneous injected，q2w

Timeline

• Start date: 2022-06-22
• Primary completion: 2024-05-30
• Completion: 2024-11-30
• First posted: 2022-05-31
• Last updated: 2023-07-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study