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Recruiting NCT07564466

A Study of SKB571 in Participants With Gastrointestinal Tumors

Phase II Interventional Gastrointestinal Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SKB571 for injection.
Who it may be relevant to
Registry conditions: Gastrointestinal Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Gastrointestinal Tumors

Overview

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.

Detailed description

This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with gastrointestinal tumors. Approximately 120 subjects will be enrolled in this study, including 4 cohorts with approximately 20-30 participants enrolled in each cohort.

Interventions

  • Drug SKB571 for injection
    Intravenous(IV) infusion(Q3W)

Primary outcome measures

  • Objective response rate (ORR) [Time frame: Up to approximately 24 months]
Secondary outcome measures (9)
  • Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS) [Time frame: Up to approximately 24 months]
  • Safety and tolerability [Time frame: Up to approximately 24 months]
  • Maximum Plasma Concentration (Cmax) of SKB571-ADC [Time frame: Up to approximately 24 months]
  • Immunogenicity [Time frame: Up to approximately 24 months]
  • Minimum Plasma Concentration(Cmin) of SKB571-ADC [Time frame: Up to approximately 24 months]
  • Maximum Plasma Concentration(Cmax) of SKB571-TAb [Time frame: Up to approximately 24 months]
  • Minimum Plasma Concentration(Cmin) of SKB571-TAb [Time frame: Up to approximately 24 months]
  • Maximum Plasma Concentration (Cmax) of unconjugated KL610348 [Time frame: Up to approximately 24 months]
  • Minimum Plasma Concentration(Cmin) of unconjugated KL610348 [Time frame: Up to approximately 24 months]

Eligibility criteria

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
  • Known active pulmonary tuberculosis.
  • Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
  • Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
  • Pregnant or breastfeeding women.
  • Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 25 centers
  • Chongqing University Three Gorges Hospital — Chongqing
  • Fujian Cancer Hospital — Fuzhou
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • Sun Yat-sen University Cancer Center — Guangzhou
  • The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou
  • The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning
  • The Fourth Hospital of Hebei Medical University — Shijiazhuang
  • Tumor Hospital of Harbin Medical University — Harbin
  • … and 17 more centers

Identifiers

NCT: NCT07564466 · SKB571-II-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗