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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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

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

Other trials in China

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

Read the detailed description

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 groups in NCT05460767
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.

31 Aug 202230 Jun 2027

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 3
Wisconsin Ginseng for Decreasing Cancer Related Fatigue
Malignant Solid Neoplasm, Chronic Lymphocytic Leukemia
Active, not recruitingPhase 2
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
Active, not recruitingPhase 2
Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
Malignant Solid Neoplasm, Recurrent Adrenal Gland Pheochromocytoma

All Solid Tumors or Lymphoma trials