Advanced MalignanciesPhase 1NCT06717880
A Study of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer
A Phase 1 study testing IBI363 combined with Bevacizumab and IBI363 + Furuitinib in people with Advanced Malignancies, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
A Phase 1 study of IBI363 in combination with Bevacizumab or Furuitinib in Subjects with Advanced Colorectal Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- IBI363 combined with Bevacizumab and IBI363 + Furuitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2023to 31 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University Hospital
Wuhan, Hubei, 430000
tao Zhang, 15827130393, whxhlzy@hust.edu.cn
About this study
Official title: 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
- Conditions
- Advanced Malignancies
- Being tested
- IBI363 combined with Bevacizumab, IBI363 + Furuitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI363 combined with BevacizumabDrug
IBI363 will be administrated on Day 1 of every 2 weeks or every 3 weeks, intravenous injection.
Bevacizumab, intravenous injection.
IBI363 + FuruitinibDrug
IBI363 Q2W or Q3W IV，Furuitinib po
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | IBI363 Combined with Bevacizumab in Subjects with Advanced Colorectal Cancer Receives: Drug: IBI363 combined with Bevacizumab |
| Cohort B | Experimental | IBI363 Combined with Furuitinib in Subjects with Advanced Colorectal Cancer Receives: Drug: IBI363 + Furuitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through out the study (up to 2 years)
Secondary outcomes (6)
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).
Measured: Through out the study (up to 2 years)
Time to response (TTR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
disease control rate (DCR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Duration of response (DoR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Progression-free survival (PFS)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Overall survival (OS)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start28 Jul 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717880
- Sponsor's protocol ID
- CIBI363Y101
- Status last verified
- Dec 2024
- First submitted
- 11 Nov 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06717880
- Acronym / sponsor ID
- CIBI363Y101
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 study of IBI363 in combination with Bevacizumab or Furuitinib in Subjects with Advanced Colorectal Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: IBI363 combined with BevacizumabIBI363 Combined with Bevacizumab in Subjects with Advanced Colorectal Cancer |
| Cohort B | Experimental | Drug: IBI363 + FuruitinibIBI363 Combined with Furuitinib in Subjects with Advanced Colorectal Cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI363 combined with BevacizumabIBI363 will be administrated on Day 1 of every 2 weeks or every 3 weeks, intravenous injection. Bevacizumab, intravenous injection. | Drug | Cohort A |
| IBI363 + FuruitinibIBI363 Q2W or Q3W IV，Furuitinib po | Drug | Cohort B |
Primary outcome
Adverse Event (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Time frame: Through out the study (up to 2 years)
Adverse events will be assessed by investigator(s) according to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
6 secondary outcomes
Objective response rate (ORR)
Time frame: Through out the study (up to 2 years)
Time to response (TTR)
Time frame: Through out the study (up to 2 years)
disease control rate (DCR)
Time frame: Through out the study (up to 2 years)
Duration of response (DoR)
Time frame: Through out the study (up to 2 years)
Progression-free survival (PFS)
Time frame: Through out the study (up to 2 years)
Overall survival (OS)
Time frame: Through out the study (up to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI363 combined with Bevacizumab and IBI363 + Furuitinib in people with Advanced Malignancies, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yanxi pu (0512-69566088, yanxi.pu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE) (time frame: Through out the study (up to 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.