> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-tolerability-and-preliminary-efficacy-of-ibi363-in-aec6e98b-c717-4538-b8b7-da9ff722e6ae > Record changed: 2026-10-13 # Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma NCT05460767 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) Participants 504 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) Lead sponsor Innovent Biologics (Suzhou) Co. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) Start date 2022-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Title and summary **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 the recommended phase 2 dose (RP2D). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Short title** Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Dates **Completion date** 2027-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **First posted** 2022-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Registry last updated** 2026-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Primary completion date** 2026-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Start date** 2022-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Size and sites **Actual participants** 504 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Participants** 504 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Lead sponsor** Innovent Biologics (Suzhou) Co. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Identifiers **Registry ID** NCT05460767 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **ClinicalTrials.gov ID** NCT05460767 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Outcomes ### Primary outcomes 1. Number of dose-limiting toxicity (DLT) Timeframe: 21 days during the first 3-week cycle Incidence of dose-limiting toxicity (DLT) events 2. incidence of adverse events (AE), serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs) Timeframe: 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. 3. Number of participants with abnormality in vital signs Timeframe: up to 90 days after the last administration Blood pressure, pulse, respiratory rate, and temperature will be assessed. 4. Number of participants with abnormality in hematology parameters Timeframe: 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) 5. Number of participants with abnormality in clinical chemistry parameters Timeframe: 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. 6. Number of participants with abnormality in routine urinalysis parameters Timeframe: 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. 7. Number of participants with abnormality in ECG parameters Timeframe: 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. ### Secondary outcomes 1. maximum concentration (Cmax) Timeframe: Up to 2 years PK parameters to be evaluated for IBI363 including maximum concentration (Cmax) will be determined when appropriate. 2. area under the curve (AUC) Timeframe: Up to 2 years PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate. 3. clearance (CL) Timeframe: Up to 2 years PK parameters to be evaluated for IBI363 including clearance (CL) will be determined when appropriate. 4. half-life (t1/2) of IBI363 Timeframe: Up to 2 years PK parameters to be evaluated for IBI363 including half-life (t1/2) will be determined when appropriate. 5. volume of distribution (V) Timeframe: Up to 2 years PK parameters to be evaluated for IBI363 including volume of distribution (V) will be determined when appropriate. 6. Objective response rate (ORR) Timeframe: Up to 2 years To evaluate the preliminary antitumor activity of IBI363 7. time to response (TTR) Timeframe: Up to 2 years To evaluate the preliminary antitumor activity of IBI363 8. duration of response (DoR) Timeframe: Up to 2 years To evaluate the preliminary antitumor activity of IBI363 9. disease control rate (DCR) Timeframe: Up to 2 years To evaluate the preliminary antitumor activity of IBI363 10. progression-free survival (PFS) Timeframe: Up to 2 years To evaluate the preliminary antitumor activity of IBI363 11. 6-month and 1-year PFS rate Timeframe: Up to 2 years To evaluate the preliminary antitumor activity of IBI363 12. Overall survival (OS) Timeframe: through study completion, an average of 1 year To evaluate the preliminary antitumor activity of IBI363 13. 6-month and 1-year OS rate Timeframe: Up to 2 years To evaluate the preliminary antitumor activity of IBI363 14. The incidence of ADA and NAb of IBI363 Timeframe: Up to 2 years 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). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Male or female subjects, ≥ 18 years 2. Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas 3. 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. 4. Subjects with at least one measurable lesion according to RECIST v1.1 for solid tumor or Lugano 2014 for lymphoma 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. Expected survival time ≥ 3 months. ### Exclusion criteria 1. 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. 2. 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. 3. Active uncontrolled bleeding or a known bleeding diathesis. 4. Subjects with massive pleural effusion or massive ascites. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Sites - First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05460767) ## Related records ### Drugs (1) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) ### Lead sponsors (1) - [Innovent Biologics (Suzhou) Co. Ltd.](https://trialight.com/data/company/innovent-biologics-suzhou-co-ltd-cd395d6d-f2bc-41a8-9a5c-6d6d1871bceb.md) ### Conditions (1) - [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) ### Targets (1) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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