Not Yet RecruitingPhase 2

A Study of SKB571 in Participants With Gastrointestinal Tumors

China120 participantsStarted 2026-06-30

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Life expectancy ≥ 12 weeks as assessed by the investigator.
✓. Adequate organ and bone marrow function.
✓. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
✓. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.

Exclusion criteria

✕. 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
✕. Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
✕. A history of severe skin diseases
✕. Unresolved toxicity from prior anti-tumor therapy
✕. Serious infection within 4 weeks before the first dose of study treatment

What they're measuring

Objective response rate (ORR)

Timeframe: Up to approximately 24 months

Trial details

NCT IDNCT07564466

SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Xin Li, MD

86-13311373861 lixin@kelun.com

View on ClinicalTrials.gov More Gastrointestinal Tumors trials