IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer
ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
IBI363 + bevacizumab
DrugIn this arm, patients will receive IBI363 plus bevacizumab
Investigator's choice of therapy
DrugIn this arm, patients will receive Fruquintinib or Trifluridine and Tipiracil Hydrochloride or Regorafenib
Treatment groups
550 Participants
are divided into 2 treatment groupsGroup A: IBI363 plus bevacizumabExperimental treatment 1 intervention
Group B: Investigator's choice of therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause
Time frame
Through out the study (an average of 2 years)Secondary outcomes
1
AE（ Adverse event）
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame
Up to 90 days after the last administration2
TEAE（ Treatment emergent adverse event）
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame
Up to 90 days after the last administration3
irAE（Immune-related AE）
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame
Up to 90 days after the last administration4
SAE（Serious adverse event）
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame
Up to 90 days after the last administrationSponsors and contacts
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Source ClinicalTrials.gov