Evaluating IBI363 for advanced solid tumors and lymphomas

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

This study is testing a new treatment called IBI363 to see if it is safe and tolerable for people with advanced solid tumors or lymphomas that haven’t responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 4 sites (Sydney, New South Wales and 3 other locations)
• Trial ID: NCT05290597 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label, multicenter study aims to assess the safety and tolerability of IBI363, a novel treatment, in patients with advanced solid malignancies or lymphomas. The study will utilize a dose-escalation approach to determine the maximum tolerated dose and the recommended phase 2 dose. Participants will include those whose cancers are not suitable for surgical intervention and who have not responded to existing therapies. The trial will monitor adverse effects and establish dosing parameters for future studies.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced, refractory solid tumors or lymphomas that are not amenable to surgery.

Not a fit: Patients with early-stage malignancies or those who have not yet undergone standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that are currently difficult to treat.

How similar studies have performed: Other studies involving PD-1 inhibitors have shown promise, suggesting potential for success with this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects, ≥ 18 years
2. Subjects with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; subjects with documented lymphomas
3. 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
4. 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.
5. Subjects with measurable or non-measurable disease according to RECIST v1.1 or standard criteria for lymphoma (Lugano 2014)
6. 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
7. 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:

1. 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.
2. 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.
3. 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.

Where this trial is running

Sydney, New South Wales and 3 other locations

• [e-mail] — Sydney, New South Wales, Australia (Recruiting)
• Westmead Hospital — Sydney, New South Wales, Australia (Recruiting)
• Sydney Southwest Private Hospital — Sydney, New South Wales, Australia (Recruiting)
• Cancer Care Wollongong — Sydney, New South Wales, Australia (Recruiting)

Study contacts

• Principal investigator: Morteza Aghmesheh — Southern Medical Day Care Centre
• Study coordinator: Min Luo

Conditions Solid Malignancies or Lymphomas