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A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors

NCT06725381 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-05-08

No results posted yet for this study

Summary

This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .

Conditions

  • Solid Malignancies

Interventions

DRUG

SKB571

SKB571 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06725381 on ClinicalTrials.gov