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

NCT05290597 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: CIBI363A101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Solid Malignancies or Lymphomas

Outcome Measures

Primary Outcomes (7)

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

  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.

  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.

  up to 90 days after the last administration

• Number of participants with abnormality in hematology parameters

  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)

  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.

  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.

  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.

  up to 90 days after the last administration

• Number of dose-limiting toxicity (DLT)

  Incidence of dose-limiting toxicity (DLT) events

  28 days during the first 4-week cycle

Secondary Outcomes (13)

• maximum concentration (Cmax)

  Up to 2 years

• area under the curve (AUC)

  Up to 2 years

• clearance (CL)

  Up to 2 years

• half-life (t1/2) of IBI363

  Up to 2 years

• Objective response rate (ORR)

  Up to 2 years

Study Arms (1)

IBI363

EXPERIMENTAL

Single arm

Biological: IBI363

Interventions

IBI363 BIOLOGICAL

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

IBI363

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fortvita Biologics (USA)Inc.: collaborator
• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (4)

Kate.Wilkinson1@health.nsw.gov.au

Sydney, New South Wales, 2109, Australia

Location

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Sydney Southwest Private Hospital

Sydney, New South Wales, 2170, Australia

Location

Cancer Care Wollongong

Sydney, New South Wales, 2500, Australia

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Morteza Aghmesheh

  Southern Medical Day Care Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: March 22, 2022
• Study Start: August 22, 2022
• Primary Completion: January 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)