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A Study of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

Phase I Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer

NCT06717880•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Sign written informed consent and be able to comply with the program's visit schedule and related procedures.
•2. Male or female subjects, age 18\~75 years.
•3. Histologically or cytologically confirmed advanced colorectal cancer.
•4. Subjects who have progressed on standard therapy, who are unsuitable for standard therapy, who do not have standard therapy, or who have refused standard therapy.
•5. Adequate organ function.
•6. At least one measurable lesion (target lesion) per RECIST v1.1.
•7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
•8. Life expectancy of 3 months or more.
•9. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.

Exclusion Criteria

•1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
•2. Active epileptic seizures or active central nervous system (CNS ) metastases and so on.
•3. Clinically significant cardiovascular or cerebrovascular disease.
•4. Interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-associated pneumonia, and radiation pneumonitis requiring steroid hormone or other therapy, as well as history of severe abnormal lung function or other forms of restrictive lung disease.
•5. History of allergies, asthma, atopic dermatitis.
•6. Subjects with large amounts of pleural effusion or ascites.
•7. Active autoimmune disease requiring systemic therapy within 2 years prior to first dose.
•8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
•9. Subjects with known or suspected hypersensitivity to the study drug and any excipients.
•10. Subject has a prior history of significant toxicity associated with immune checkpoint inhibitor administration or Bevacizumab that requires permanent discontinuation.
+7 more criteria

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University Hospital

Wuhan, Hubei, China

Key Dates

Start Date

July 28, 2023

Primary Completion Date

July 31, 2025

Completion Date

July 31, 2026

Last Updated

February 12, 2025

Enrollment

260

ESTIMATED participants

Conditions

Advanced Malignancies

Interventions

IBI363 combined with Bevacizumab

DRUG

IBI363 + Furuitinib

DRUG

Contacts

yanxi pu

CONTACT

0512-69566088 yanxi.pu@innoventbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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