NCT05991583

A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors

A Phase I/II Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBB0979 in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, open-label, dose escalation and dose expansion study designed to characterize the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of IBB0979 in previously treated patients with locally advanced or metastatic solid tumors.

Detailed description

The study consists of Dose Escalation Phase, Dose Expansion Phase and Clinical Exploration Phase. Dose Escalation Phase：This phase is an open-label, non-randomized, multicenter, dose-escalation study. From the starting dose of 0.01 mg/kg, an accelerated titration combined with a "3+3" design will be adopted. Dose Expansion Phase：The application of Dose Expansion Phase can be discussed by investigator and sponsor based on data obtained in Dose Escalation Phase. This phase is an open-label, non-randomized, multicenter study. 6 patients with locally advanced or metastatic solid tumors are expected to be enrolled at DRDE. Each treatment cycle is defined as 21 days, patient may receive treatment until withdrawal or Treatment Discontinuation. Clinical Exploration Phase：After completing the dose escalation and expansion studies, the indication and study population can be discussed by the investigator and sponsor based on the efficacy and safety data that have been obtained.

Conditions

• Advanced Malignant Tumors

Interventions

Type	Name	Description
DRUG	IBB0979	IBB0979 should be subcutaneous injected，qw

Timeline

• Start date: 2023-07-03
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2023-08-14
• Last updated: 2025-01-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study