This study was conducted in accordance with the requirements of the clinical approval document (CFDA2013L01855). It was a single-center, open-label, single-dose escalation Phase I clinical trial, with both human tolerability and pharmacokinetic studies performed simultaneously.

Trial objectives:

To observe the tolerability of CHA for injection in humans and to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in patients with advanced malignant tumors.

Target group:

Patients with malignant solid tumors confirmed by histopathology or cytology.  

Clinical results:

1、Tolerability and safety

In the phase I dose-escalation study of CHA for injection as a monotherapy for advanced solid tumors, no drug-related dose-limiting toxicities (DLT) were observed. The subjects demonstrated good tolerability to CHA for injection.

2、Efficacy

For advanced cancer patients (e.g., lung cancer, rectal cancer and prostate cancer) who have failed conventional treatments, CHA for injection demonstrated a high clinical benefit rate, as evaluated according to RECIST 1.0, suggesting its potential anti-tumor efficacy.  

CHA for injection has shown clinical characteristics of being safe, effective, and having a wide therapeutic spectrum.