Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06404905

Clinical Trial of BT02 in Patients With Advanced Solid Tumors

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-12-27

60

Participants Needed

1

Research Sites

48 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors

CONDITIONS

Official Title

Clinical Trial of BT02 in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older at the time of signing the informed consent form, male or female
  • Histologically or cytologically confirmed diagnosis of advanced solid tumor
  • Adequate organ and blood function
  • At least measurable or evaluable tumor lesion in Phase I and measurable lesion in Phase II per RECIST 1.1
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Ability and willingness to comply with follow-up visits
Not Eligible

You will not qualify if you...

  • Prior systemic anti-cancer therapy
  • Active or documented autoimmune disease within the past 2 years
  • History of significant cardiovascular disease
  • Significant acute or chronic infections
  • Residual toxicities from previous anti-cancer treatments not improved to Grade 3 severity
  • Any prior Grade 3 or higher immune-related adverse event from immunotherapy
  • Unstable brain or meningeal metastases with symptoms
  • Mental disorders or poor compliance
  • Known alcohol or drug abuse
  • Other severe systemic diseases or conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cancer Institute and Hospital

Beijing, Biejing, China, 1000021

Actively Recruiting

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Research Team

N

Ning Li, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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