NCT06581419

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

A Phase I/II Clinical Study Evaluating Safety, Tolerability, and Efficacy of IAP0971 in Advanced Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase I: To evaluate the safety, tolerance and effectiveness of IAP0971 for the treatment of advanced malignant tumors. Phase II: Evaluation of IAP0971 therapy driver negative and PD-L1 positive (TPS≥50%) The initial treatment is effective in subjects with advanced or metastatic non-small cell lung cancer.

Detailed description

The study includes dose-escalation (Phase I) and dose-expansion (Phase II) clinical trials. Phase I clinical trials will be conducted first. After completing the dose-escalation phase, the plan is to determine the recommended Phase II dose (RP2D) in the maximum tolerated dose (MTD) group and proceed with the subsequent Phase II exploratory studies. The objective of the Phase I dose-escalation phase is to preliminarily assess the safety and tolerability of IAP0971 and to determine the MTD based on the incidence of dose-limiting toxicities (DLTs) in each dose group. Phase II will use an open-label, non-randomized, single-arm, multicenter design. The study will evaluate adverse events and adverse reactions through clinical observation, vital sign monitoring, and laboratory tests. Tumor assessments will be conducted using RECIST 1.1 criteria: within 48 weeks of the first infusion of the investigational drug, assessments will be performed after every two cycles (±7 days), and after 48 weeks, assessments will occur every four cycles (±7 days) until disease progression, initiation of new anti-tumor therapy, investigator-determined ineligibility (e.g., intolerable adverse reactions), loss to follow-up, voluntary withdrawal, death, or study termination/suspension.

Conditions

• Advanced Malignant Neoplasm
• Advanced or Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	IAP0971	Subjects receive IAP0971, which will be administered every 3 weeks in a 3-week cycle.

Timeline

• Start date: 2024-12-31
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2024-09-03
• Last updated: 2025-01-15

Locations

1 site across 1 country: China