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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignancies
• Intervention / Treatment: Drug: IBI363 combined with Bevacizumab; Drug: IBI363 + Furuitinib

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: yanxi pu; Phone Number: 0512-69566088; Email: yanxi.pu@innoventbio.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University Hospital
      • Contact: tao Zhang; Phone Number: 15827130393; Email: whxhlzy@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A; IBI363 Combined with Bevacizumab in Subjects with Advanced Colorectal Cancer	Drug: IBI363 combined with Bevacizumab; IBI363 will be administrated on Day 1 of every 2 weeks or every 3 weeks, intravenous injection. Bevacizumab, intravenous injection.
Experimental: Cohort B; IBI363 Combined with Furuitinib in Subjects with Advanced Colorectal Cancer	Drug: IBI363 + Furuitinib; IBI363 Q2W or Q3W IV，Furuitinib po

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	The efficacy of solid tumors was evaluated according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1).	Through out the study (up to 2 years)
Time to response (TTR)	The efficacy of solid tumors was evaluated according to RECIST v1.1	Through out the study (up to 2 years)
disease control rate (DCR)	The efficacy of solid tumors was evaluated according to RECIST v1.1	Through out the study (up to 2 years)
Duration of response (DoR)	The efficacy of solid tumors was evaluated according to RECIST v1.1	Through out the study (up to 2 years)
Progression-free survival (PFS)	The efficacy of solid tumors was evaluated according to RECIST v1.1	Through out the study (up to 2 years)
Overall survival (OS)	The efficacy of solid tumors was evaluated according to RECIST v1.1	Through out the study (up to 2 years)

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: CIBI363Y101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No