Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
- 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).
- Short title
- Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-06-30
- First posted
- 2022-07-15
- Registry last updated
- 2026-08-25
- Primary completion date
- 2026-12-31
- Start date
- 2022-08-31
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05460767
- ClinicalTrials.gov ID
- NCT05460767
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Number of dose-limiting toxicity (DLT)
Timeframe: 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)
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.
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.
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)
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.
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.
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.
maximum concentration (Cmax)
Timeframe: Up to 2 years
PK parameters to be evaluated for IBI363 including maximum concentration (Cmax) will be determined when appropriate.
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.
clearance (CL)
Timeframe: Up to 2 years
PK parameters to be evaluated for IBI363 including clearance (CL) will be determined when appropriate.
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.
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.
Objective response rate (ORR)
Timeframe: Up to 2 years
To evaluate the preliminary antitumor activity of IBI363
time to response (TTR)
Timeframe: Up to 2 years
To evaluate the preliminary antitumor activity of IBI363
duration of response (DoR)
Timeframe: Up to 2 years
To evaluate the preliminary antitumor activity of IBI363
disease control rate (DCR)
Timeframe: Up to 2 years
To evaluate the preliminary antitumor activity of IBI363
progression-free survival (PFS)
Timeframe: Up to 2 years
To evaluate the preliminary antitumor activity of IBI363
6-month and 1-year PFS rate
Timeframe: Up to 2 years
To evaluate the preliminary antitumor activity of IBI363
Overall survival (OS)
Timeframe: through study completion, an average of 1 year
To evaluate the preliminary antitumor activity of IBI363
6-month and 1-year OS rate
Timeframe: Up to 2 years
To evaluate the preliminary antitumor activity of IBI363
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).
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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.
- First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, China