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

NCT ID: NCT06717880

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2026-07-31

Brief Summary

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

Conditions

Advanced Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

IBI363 Combined with Bevacizumab in Subjects with Advanced Colorectal Cancer

Group Type: EXPERIMENTAL

IBI363 combined with Bevacizumab

Intervention Type: DRUG

IBI363 will be administrated on Day 1 of every 2 weeks or every 3 weeks, intravenous injection.

Bevacizumab, intravenous injection.

Cohort B

IBI363 Combined with Furuitinib in Subjects with Advanced Colorectal Cancer

Group Type: EXPERIMENTAL

IBI363 + Furuitinib

Intervention Type: DRUG

IBI363 Q2W or Q3W IV，Furuitinib po

Interventions

IBI363 combined with Bevacizumab

IBI363 will be administrated on Day 1 of every 2 weeks or every 3 weeks, intravenous injection.

Bevacizumab, intravenous injection.

Intervention Type: DRUG

IBI363 + Furuitinib

IBI363 Q2W or Q3W IV，Furuitinib po

Intervention Type: DRUG

Eligibility Criteria

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.

11. Subjects with unresolved > Grade 1 toxicity associated with any prior antineoplastic therapy, with the exception of persistent Grade 2 alopecia, peripheral neuropathy and so on.

12. Active uncontrolled bleeding or known bleeding tendency.

13. Any major surgery within 4 weeks prior to the first dose of study drug.

14. Known positive Human Immunodeficiency Virus (HIV) test, active hepatitis B, hepatitis C (HCV), tuberculosis.

15. Severe/active/uncontrolled infection, infection requiring systemic intravenous antibiotic therapy, or unexplained fever within 2 weeks prior to the first dose of study drug.

16. Diagnosis of another malignancy within 5 years prior to the first dose, exceptions include radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ, as well as post-radical localized prostate cancer, and papillary thyroid cancer.

17. Presence of any disease, treatment or laboratory test abnormality, or history or current evidence of substance abuse that, in the judgment of the investigator, may compromise the safety of the subject, interfere with obtaining informed consent, affect subject compliance, or compromise the safety evaluation of the study drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Union Hospital, Tongji Medical College, Huazhong University Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

yanxi pu

Role: CONTACT

yanxi.pu@innoventbio.com

0512-69566088

Facility Contacts

tao Zhang

Role: primary

whxhlzy@hust.edu.cn

15827130393

Other Identifiers

CIBI363Y101

Identifier Type: -

Identifier Source: org_study_id