Skip to main content
OpenTrials
Active, not recruiting

NCT Number: NCT05460767

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).

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Solid Tumors or Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

IBI363

Biological

a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.

Bevacizumab

Drug

Recombinant humanized monoclonal antibody against vascular endothelial growth factor

Primary outcomes

  1. Number of dose-limiting toxicity (DLT)

    Time frame: 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)

    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.

  3. 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.

  4. 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)

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. maximum concentration (Cmax)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  7. time to response (TTR)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  8. duration of response (DoR)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  9. disease control rate (DCR)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  10. progression-free survival (PFS)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  11. 6-month and 1-year PFS rate

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  12. Overall survival (OS)

    Time frame: through study completion, an average of 1 year

    To evaluate the preliminary antitumor activity of IBI363

  13. 6-month and 1-year OS rate

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  14. The incidence of ADA and NAb of IBI363

    Time frame: 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).

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 15, 2022
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.