A Study of SKB571 in Participants With Gastrointestinal Tumors

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 in participants with gastrointestinal tumors.

Eligibility criteria

Qualifiers

Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).

Participants must have histologically or cytologically confirmed gastrointestinal tumors.

At least one measurable lesion as assessed by the investigator according to RECIST v1.1.

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

Disqualifiers

Participants with other malignant tumors within 3 years before the first dose of study treatment.

History or current metastases to central nervous system.

Current uncontrolled concomitant diseases

Clinically severe lung damage due to complications of lung disorder

Trial design

Treatments tested in this trial

  • SKB571 for injection

Treatment groups

120 Participants
are divided into 4 treatment groups