drugset
drugset / Trial / NCT07584057

An Phase I/IIa Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of INB301 Injection in Patients With Cancer Cachexia

NCT07584057 ↗

Phase 1/2 Not yet recruiting 146 enrolled Yunnan Baiyao Group Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, multiple-dose Phase I/IIa clinical study to assess the safety/tolerability, PK characteristics,immunogenicity, and preliminary efficacy of INB301 Injection in patients with cancer cachexia. The indication to be explored for Phase I is malignant solid tumor with cachexia; Phase IIa will determine the specific study cohort after discussion between the investigator and the sponsor based on the previously obtained clinical trial data and the benefit/risk ratio of the subjects, and preliminarily consider 3 cohorts of tentative 20-30 patients each, including non-small cell lung cancer, pancreatic cancer and colorectal cancer with cachexia.

Timeline

Start
2026-05
Primary completion
2030-02
Completion
2030-03

Drugs

EvaluationDrugModalityDoseRoute
Subject INB301 Unknown 50 mg Subcutaneous
Subject INB301 Unknown 100 mg Subcutaneous
Subject INB301 Unknown 200 mg Subcutaneous
Subject INB301 Unknown 300 mg Subcutaneous
Subject INB301 Unknown 400 mg Subcutaneous
Subject INB301 Unknown 500 mg Subcutaneous

Indications

No indication recorded.