Solid Tumors or LymphomaPhase 1NCT05460767
Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
A Phase 1 study testing IBI363 and Bevacizumab in people with Solid Tumors or Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors or Lymphoma
- What is being tested?
- IBI363 and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2022to 30 Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, ≥ 18 years
- Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas
- Subjects who progressed or are intolerant to existing standard therapy or subjects without standard therapy Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial.
- Subjects with at least one measurable lesion according to RECIST v1.1 for solid tumor or Lugano 2014 for lymphoma
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Expected survival time ≥ 3 months.
Who cannot join
- Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
- Subjects with active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable.
- Active uncontrolled bleeding or a known bleeding diathesis.
- Subjects with massive pleural effusion or massive ascites.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
About this study
Official title: A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D).
Read the detailed description
This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D). The phase Ia part consists of the dose escalation and PD marker exploration part. The phase Ib part consists of the dose expansion part.
- Conditions
- Solid Tumors or Lymphoma
- Being tested
- IBI363, Bevacizumab
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI363Biological
a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
BevacizumabDrug
Recombinant humanized monoclonal antibody against vascular endothelial growth factor
| Study group | Role | What they receive |
|---|---|---|
| IBI363 | Experimental | Arm 1 Receives: Biological: IBI363 |
| IBI363+Bevacizumab | Experimental | Arm 2 Receives: Biological: IBI363; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) events
Measured: 21 days during the first 3-week cycle
incidence of adverse events (AE), serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
AE is defined as an medical problem that happens during treatment with a drug or other therapy. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.
Measured: up to 90 days after the last administration
Number of participants with abnormality in vital signs
Blood pressure, pulse, respiratory rate, and temperature will be assessed.
Measured: up to 90 days after the last administration
Number of participants with abnormality in hematology parameters
Blood samples will be collected to evaluate hemoglobin, white blood cell (WBC) count, platelets and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT)
Measured: up to 90 days after the last administration
Number of participants with abnormality in clinical chemistry parameters
Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.
Measured: up to 90 days after the last administration
Number of participants with abnormality in routine urinalysis parameters
Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.
Measured: up to 90 days after the last administration
Number of participants with abnormality in ECG parameters
12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.
Measured: up to 90 days after the last administration
Secondary outcomes (14)
maximum concentration (Cmax)
PK parameters to be evaluated for IBI363 including maximum concentration (Cmax) will be determined when appropriate.
Measured: Up to 2 years
area under the curve (AUC)
PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate.
Measured: Up to 2 years
clearance (CL)
PK parameters to be evaluated for IBI363 including clearance (CL) will be determined when appropriate.
Measured: Up to 2 years
half-life (t1/2) of IBI363
PK parameters to be evaluated for IBI363 including half-life (t1/2) will be determined when appropriate.
Measured: Up to 2 years
volume of distribution (V)
PK parameters to be evaluated for IBI363 including volume of distribution (V) will be determined when appropriate.
Measured: Up to 2 years
Objective response rate (ORR)
To evaluate the preliminary antitumor activity of IBI363
Measured: Up to 2 years
time to response (TTR)
To evaluate the preliminary antitumor activity of IBI363
Measured: Up to 2 years
duration of response (DoR)
To evaluate the preliminary antitumor activity of IBI363
Measured: Up to 2 years
disease control rate (DCR)
To evaluate the preliminary antitumor activity of IBI363
Measured: Up to 2 years
progression-free survival (PFS)
To evaluate the preliminary antitumor activity of IBI363
Measured: Up to 2 years
6-month and 1-year PFS rate
To evaluate the preliminary antitumor activity of IBI363
Measured: Up to 2 years
Overall survival (OS)
To evaluate the preliminary antitumor activity of IBI363
Measured: through study completion, an average of 1 year
6-month and 1-year OS rate
To evaluate the preliminary antitumor activity of IBI363
Measured: Up to 2 years
The incidence of ADA and NAb of IBI363
Each subject will be tested for anti-drug (IBI363) antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb).
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.
- First posted15 Jul 2022
- Study start31 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors or LymphomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460767
- Sponsor's protocol ID
- CIBI363A102
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2022
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT05460767
- Acronym / sponsor ID
- CIBI363A102
- Conditions
- Solid Tumors or Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Jul 2022 (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.
This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D).
Detailed description
This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D). The phase Ia part consists of the dose escalation and PD marker exploration part. The phase Ib part consists of the dose expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI363 | Experimental | Biological: IBI363Arm 1 |
| IBI363+Bevacizumab | Experimental | Biological: IBI363, Drug: BevacizumabArm 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects, ≥ 18 years
- Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas
- Subjects who progressed or are intolerant to existing standard therapy or subjects without standard therapy Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial.
- Subjects with at least one measurable lesion according to RECIST v1.1 for solid tumor or Lugano 2014 for lymphoma
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Key exclusion criteria (4 listed)
- Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
- Subjects with active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable.
- Active uncontrolled bleeding or a known bleeding diathesis.
- Subjects with massive pleural effusion or massive ascites.
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 |
|---|---|---|
| IBI363a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade. | Biological | IBI363, IBI363+Bevacizumab |
| BevacizumabRecombinant humanized monoclonal antibody against vascular endothelial growth factor | Drug | IBI363+Bevacizumab |
Primary outcome
Number of dose-limiting toxicity (DLT)
Time frame: 21 days during the first 3-week cycle
Incidence of dose-limiting toxicity (DLT) events
incidence of adverse events (AE), serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
Time frame: up to 90 days after the last administration
AE is defined as an medical problem that happens during treatment with a drug or other therapy. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.
Number of participants with abnormality in vital signs
Time frame: up to 90 days after the last administration
Blood pressure, pulse, respiratory rate, and temperature will be assessed.
Number of participants with abnormality in hematology parameters
Time frame: up to 90 days after the last administration
Blood samples will be collected to evaluate hemoglobin, white blood cell (WBC) count, platelets and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT)
Number of participants with abnormality in clinical chemistry parameters
Time frame: up to 90 days after the last administration
Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.
Number of participants with abnormality in routine urinalysis parameters
Time frame: up to 90 days after the last administration
Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.
Number of participants with abnormality in ECG parameters
Time frame: up to 90 days after the last administration
12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.
14 secondary outcomes
maximum concentration (Cmax)
Time frame: Up to 2 years
area under the curve (AUC)
Time frame: Up to 2 years
clearance (CL)
Time frame: Up to 2 years
half-life (t1/2) of IBI363
Time frame: Up to 2 years
volume of distribution (V)
Time frame: Up to 2 years
Objective response rate (ORR)
Time frame: Up to 2 years
time to response (TTR)
Time frame: Up to 2 years
duration of response (DoR)
Time frame: Up to 2 years
disease control rate (DCR)
Time frame: Up to 2 years
progression-free survival (PFS)
Time frame: Up to 2 years
6-month and 1-year PFS rate
Time frame: Up to 2 years
Overall survival (OS)
Time frame: through study completion, an average of 1 year
6-month and 1-year OS rate
Time frame: Up to 2 years
The incidence of ADA and NAb of IBI363
Time frame: 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 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Bevacizumab in people with Solid Tumors or Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. 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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 25 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dose-limiting toxicity (DLT) (time frame: 21 days during the first 3-week cycle). The study lists 7 primary outcomes in all. 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 25 Aug 2026.