A Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the preliminary efficacy.

Eligibility criteria

Qualifiers

Subjects with ability to understand and voluntarily agree to participate by giving written informed consent for the study.

Patients with unresectable recurrent or metastatic solid tumors.

There is at least one lesion that could be measured.

An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

Disqualifiers

Patients with known active central nervous system (CNS) metastases.

Subjects who had other malignancy in five years before the first dose.

Patients with tumor-related pain that can not be controlled as determined.

Patients with serious cardiovascular and cerebrovascular diseases.

Trial design

Treatments tested in this trial

  • FH-006 for Injection

Treatment groups

150 Participants
are divided into 1 treatment group