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NCT Number: NCT05290597

A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas

This is a Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI363 (study drug) in subjects with advanced, refractory solid malignancies or lymphomas.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Solid Malignancies or Lymphomas 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

Cancer Care Wollongong, Sydney, New South Wales, Australia

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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
  • Subjects with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; subjects with documented lymphomas
  • Subjects with a malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
  • Subjects who are refractory to or intolerant to existing therapy(ies) known to provide clinical benefit 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 measurable or non-measurable disease according to RECIST v1.1 or standard criteria for lymphoma (Lugano 2014)
  • Subjects, both male and female, who are either not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug
  • Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol

Exclusion criteria

  • Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. Women of childbearing potential (WOCBP) or fertile men with WOCBP partner(s), not using and not willing to use a highly effective method of contraception.
  • 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.

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.

Primary outcomes

  1. Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)

    Time frame: up to 90 days after the last administration

    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.

  2. 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.

  3. 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, mean corpuscular volume (MCV), white blood cell (WBC) count, platelets, 5-part differential white cell count, mean platelet volume and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT)

  4. 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.

  5. 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.

  6. 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.

  7. Number of dose-limiting toxicity (DLT)

    Time frame: 28 days during the first 4-week cycle

    Incidence of dose-limiting toxicity (DLT) events

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 area under the curve (AUC) 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 volume of distribution (V) will be determined when appropriate.

  5. Objective response rate (ORR)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  6. time to response (TTR)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  7. duration of response (DoR)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  8. disease control rate (DCR)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  9. progression-free survival (PFS)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  10. 6-month and 1-year PFS rate per RECIST v1.1 for subjects with solid tumors, and per Lugano 2014 for subjects with lymphomas

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  11. Overall survival (OS)

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

    To evaluate the preliminary antitumor activity of IBI363

  12. survival rates (6-month and 1-year)

    Time frame: Up to 2 years

    To evaluate the preliminary antitumor activity of IBI363

  13. 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).

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Collaborators

  • Fortvita Biologics (USA)Inc.

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2022
Registry last updated
Mar 5, 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.

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