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Colorectal CancerPhase 3NCT07722494

IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer

A Phase 3 study testing IBI363 + bevacizumab and Investigator's choice of therapy in people with Colorectal Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open-label, multicenter Phase 3 study to evaluate the safety and tolerability of IBI363 plus bevacizumab in patients with advanced colorectal cancer refractory or intolerant to standard-of-care therapy Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
IBI363 + bevacizumab and Investigator's choice of therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
2 sitesChina
Study dates
31 Jul 2026to 31 Dec 2030
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has signed the written Informed Consent Form and is capable of complying with the visit schedules and relevant procedures specified in the protocol.
  • Aged ≥ 18 years, with no restriction on gender.
  • Histologically or cytologically confirmed unresectable metastatic colorectal adenocarcinoma.
  • Has experienced treatment failure or intolerance to prior systemic standard therapies administered for metastatic disease, with failure or intolerance occurring on the most recent line of systemic therapy.
  • Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
  • Colorectal cancer characterized by proficient mismatch repair (pMMR), or microsatellite stable (MSS) status.
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  • Confirmed adequate bone marrow and organ function at screening.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
  • Expected survival duration ≥ 3 months.
  • Female subjects of childbearing potential, or male subjects whose partners are females of childbearing potential, agree to strictly use effective contraceptive measures throughout the treatment period and for 6 months after treatment completion. Lactating female subjects agree to completely refrain from breastfeeding throughout the treatment period and for 6 months after treatment completion.

Who cannot join

  • Prior disease progression, treatment intolerance, or contraindication to all three agents: fruquintinib, trifluridine/tipiracil (TAS-102), and regorafenib.
  • Prior receipt of immunotherapy targeting anti-PD-(L)-1 or PD-L2 in the metastatic setting.
  • History of severe toxicities related to anti-PD-(L)-1 immunotherapy or anti-VEGF therapy that necessitated permanent discontinuation of treatment, or contraindication to any of the above agents.
  • Prior administration of interleukin (IL)-2 or IL-15 cytokines.
  • Absence of documented clear evidence to confirm left- or right-sided primary colorectal tumor; or presence of primary colorectal lesions on both sides.
  • Radiologically confirmed active or symptomatic central nervous system (CNS) metastases, including intraparenchymal brain, leptomeningeal, and spinal cord metastases.
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  • Subjects with unresolved adverse events attributable to any prior anti-tumor therapy that have not recovered to NCI CTCAE (Version 5.0) Grade 0 or Grade 1, or returned to baseline levels prior to randomization. Exceptions include alopecia, fatigue, hypothyroidism managed solely with thyroid hormone replacement, hyperglycemia controlled exclusively by insulin replacement, electrolyte abnormalities manageable with symptomatic treatment only, and other conditions judged by the Investigator to pose no safety risks with study drug administration.
  • History of another malignant tumor within 5 years before the first dose of study drug. The following malignancies are allowed if curatively resected, with no current evidence of residual or recurrent disease and an extremely low recurrence risk: carcinoma in situ, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, lentigo maligna, localized prostate cancer, papillary thyroid carcinoma, non-invasive papillary urothelial carcinoma.
  • Active autoimmune disease requiring systemic therapy (e.g., disease-modifying anti-rheumatic drugs, corticosteroids, immunosuppressants) within 2 years prior to the first study drug dose. Replacement therapies (e.g., thyroxine, insulin, physiological corticosteroids for adrenal or pituitary insufficiency) shall not be regarded as systemic immunosuppressive treatment.
  • Prior history of interstitial lung disease, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis, or other pulmonary disorders requiring corticosteroids or other therapeutic intervention.
  • Active uncontrolled bleeding or known bleeding diathesis;
  • Known history of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Subjects with known or suspected hypersensitivity to the study drug or any of its excipients.
  • Female subjects who are pregnant, breastfeeding, or planning to conceive before study drug administration, during treatment, or within 6 months after the last study drug dose.
  • Any past medical condition, prior treatment, or abnormal laboratory findings, or current clinical evidence that, in the Investigator's judgment, may compromise subject safety, interfere with the acquisition of informed consent, impair subject compliance, or confound the safety evaluation of the study drug; subjects with psychiatric disorders, altered mental status, or substance abuse that impairs the ability to comprehend the informed consent process and/or complete required study assessments; subjects whom the Investigator determines will fail to comply with protocol requirements for known or foreseeable reasons.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

binbin Min contact

0512-69566088

bingo.min@innoventbio.com

China2 sites, 2 recruiting

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310021

    Kefeng Ding, Medical Doctor, 0571-87783777, dingkefeng@zju.edu.cn

    Ying Yuan, Medical Doctor, 0571-87783777, yuanying1999@zju.edu.cn

    Recruiting

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

    Wuhan, Wuhan, 430021

    Tao Zhang, Medical Doctor, 027-65650989, taozhangwh@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI363 in Combination With Bevacizumab Versus Investigator's Choice of Therapy in Participants With Advanced Colorectal Cancer Who Have Failed or Are Intolerant to Standard Care of Therapy

This is an open-label, multicenter Phase 3 study to evaluate the safety and tolerability of IBI363 plus bevacizumab in patients with advanced colorectal cancer refractory or intolerant to standard-of-care therapy

Being tested
IBI363 + bevacizumab, Investigator's choice of therapy
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI363 + bevacizumabDrug

    In this arm, patients will receive IBI363 plus bevacizumab

  • Investigator's choice of therapyDrug

    Also called Fruquintinib or Trifluridine and Tipiracil Hydrochloride or Regorafenib

    In this arm, patients will receive Fruquintinib or Trifluridine and Tipiracil Hydrochloride or Regorafenib

Study groups in NCT07722494
Study groupRoleWhat they receive
IBI363 plus bevacizumabExperimentalIBI363 in combination with bevacizumab in participants with advanced colorectal cancer who have failed or are intolerant to standard care of therapy
Receives: Drug: IBI363 + bevacizumab
Investigator's choice of therapyActive comparatorInvestigator's choice of therapy in participants with advanced colorectal cancer who have failed or are intolerant to standard care of therapy
Receives: Drug: Investigator's choice of therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    OS is defined as the time from the date of randomization until the date of death from any cause

    Measured: Through out the study (an average of 2 years)

Secondary outcomes (14)

  1. AE（ Adverse event）

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

    Measured: Up to 90 days after the last administration

  2. TEAE（ Treatment emergent adverse event）

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

    Measured: Up to 90 days after the last administration

  3. irAE（Immune-related AE）

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

    Measured: Up to 90 days after the last administration

  4. SAE（Serious adverse event）

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

    Measured: Up to 90 days after the last administration

  5. AESI（Adverse Event of Special Interest）

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

    Measured: Up to 90 days after the last administration

  6. progression-free survival (PFS)

    PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause, whichever occurs first

    Measured: Through out the study (up to 2 years)

  7. Objective response rate (ORR)

    ORR is defined as the proportion of participants in the analysis set who achieve a confirmed objective response (complete response [CR] or partial response [PR])

    Measured: Through out the study (up to 2 years)

  8. disease control rate (DCR)

    DCR is defined as the proportion of participants with a complete response (CR) or partial response (PR) or stable disease (SD)

    Measured: Through out the study (up to 2 years)

  9. time to response (TTR)

    TTR is defined as the time from the date of randomization to the date of first documented tumor response (CR/PR)

    Measured: Through out the study (up to 2 years)

  10. duration of response (DoR)

    DoR is defined as the time from the date of first documented tumor response (CR/PR) until progression or death due to any cause, whichever occurs first.

    Measured: Through out the study (up to 2 years)

  11. Half-life (T1/2) of IBI363

    PK（Pharmacokinetics） parameters half-life (t1/2) of IBI363

    Measured: Up to 2 years

  12. Clearance (CL) of IBI363

    PK parameters clearance rate of IBI363

    Measured: Up to 2 years

  13. Volume of distribution (V) of IBI363

    PK parameters apparent volume of distribution(V) of IBI363

    Measured: Up to 2 years

  14. Immunogenicity of IBI363

    Incidence of anti-IBI363 anti-drug antibodies (ADAs) and/or neutralizing antibodies (NAbs)

    Measured: 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.

  1. First posted23 Jul 2026
  2. Study start31 Jul 2026
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07722494
Sponsor's protocol ID
CIBI363D301
Status last verified
Aug 2026
First submitted
20 Jul 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IBI363 + bevacizumab and Investigator's choice of therapy in people with Colorectal Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 2 sites 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 10 inclusion and 15 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 binbin Min (0512-69566088, bingo.min@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: Through out the study (an average of 2 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07722494.

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 10 Aug 2026.

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