Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06717880

A Study of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-02-12

260

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A Phase 1 study of IBI363 in combination with Bevacizumab or Furuitinib in Subjects with Advanced Colorectal Cancer

CONDITIONS

Official Title

A Study of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and ability to follow study visits and procedures
  • Male or female aged 18 to 75 years
  • Histologically or cytologically confirmed advanced colorectal cancer
  • Disease progressed on or unsuitable/refused standard therapy
  • Adequate organ function
  • At least one measurable lesion per RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Life expectancy of 3 months or more
  • Agree to use effective contraception during treatment and for 6 months after if of childbearing potential
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women or planning pregnancy before, during, or within 6 months after treatment
  • Active epileptic seizures or active central nervous system metastases
  • Significant cardiovascular or cerebrovascular disease
  • Severe lung diseases including interstitial pneumonia or radiation pneumonitis requiring treatment
  • History of allergies, asthma, or atopic dermatitis
  • Large pleural effusion or ascites
  • Active autoimmune disease needing systemic therapy within 2 years
  • History of organ or stem cell transplantation
  • Known hypersensitivity to study drugs or excipients
  • Previous severe toxicity from immune checkpoint inhibitors or Bevacizumab requiring stopping treatment
  • Unresolved grade >1 toxicity from prior cancer therapies (except some mild conditions)
  • Active uncontrolled bleeding or bleeding disorders
  • Major surgery within 4 weeks before starting study drug
  • Positive HIV, active hepatitis B or C, or tuberculosis
  • Severe or uncontrolled infections or unexplained fever within 2 weeks before treatment
  • Diagnosis of another cancer within 5 years except certain treated skin or prostate cancers
  • Any condition or history that may affect safety, consent, compliance, or safety evaluation as judged 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

Union Hospital, Tongji Medical College, Huazhong University Hospital

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

Y

yanxi pu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

2

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