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

NCT06717880 | Recruiting Phase 1

• 1 other identifier: CIBI363Y101
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (1)

• Adverse Event (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)

  Adverse events will be assessed by investigator(s) according to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).

  Through out the study (up to 2 years)

Secondary Outcomes (6)

• Objective response rate (ORR)

  Through out the study (up to 2 years)

• Time to response (TTR)

  Through out the study (up to 2 years)

• disease control rate (DCR)

  Through out the study (up to 2 years)

• Duration of response (DoR)

  Through out the study (up to 2 years)

• Progression-free survival (PFS)

  Through out the study (up to 2 years)

Study Arms (2)

Cohort A

EXPERIMENTAL

IBI363 Combined with Bevacizumab in Subjects with Advanced Colorectal Cancer

Drug: IBI363 combined with Bevacizumab

Cohort B

EXPERIMENTAL

IBI363 Combined with Furuitinib in Subjects with Advanced Colorectal Cancer

Drug: IBI363 + Furuitinib

Interventions

IBI363 combined with Bevacizumab DRUG

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

Cohort A

IBI363 + Furuitinib DRUG

IBI363 Q2W or Q3W IV，Furuitinib po

Cohort B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign written informed consent and be able to comply with the program's visit schedule and related procedures.
• Male or female subjects, age 18\~75 years.
• Histologically or cytologically confirmed advanced colorectal cancer.
• 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.
• Adequate organ function.
• At least one measurable lesion (target lesion) per RECIST v1.1.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Life expectancy of 3 months or more.
• 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.

You may not qualify if:

• Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
• Active epileptic seizures or active central nervous system (CNS ) metastases and so on.
• Clinically significant cardiovascular or cerebrovascular disease.
• 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.
• History of allergies, asthma, atopic dermatitis.
• Subjects with large amounts of pleural effusion or ascites.
• Active autoimmune disease requiring systemic therapy within 2 years prior to first dose.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Subjects with known or suspected hypersensitivity to the study drug and any excipients.
• Subject has a prior history of significant toxicity associated with immune checkpoint inhibitor administration or Bevacizumab that requires permanent discontinuation.
• 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.
• Active uncontrolled bleeding or known bleeding tendency.
• Any major surgery within 4 weeks prior to the first dose of study drug.
• Known positive Human Immunodeficiency Virus (HIV) test, active hepatitis B, hepatitis C (HCV), tuberculosis.
• Severe/active/uncontrolled infection, infection requiring systemic intravenous antibiotic therapy, or unexplained fever within 2 weeks prior to the first dose of study drug.

Sponsors & Collaborators

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

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

yanxi pu

CONTACT

0512-69566088; yanxi.pu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: December 5, 2024
• Study Start: July 28, 2023
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)