drugset / Trial / NCT04912466

IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.

NCT04912466 ↗

Phase 1 Completed 61 enrolled Innovent Biologics (Suzhou) Co. Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia.

Timeline

Start
2021-07-21
Primary completion
2022-12-03
Completion
2023-08-25

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI322 Monoclonal antibody — —

Indications