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

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Mar 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IBI363 (also known as PD1-IL2m) for patients with advanced solid tumors or lymphomas, which are types of cancer. The main goal of the trial is to find out how safe the treatment is and to determine the highest dose that can be given without causing serious side effects. This is a Phase 1 study, meaning it’s an early test of the drug in people, and it’s open to both men and women aged 18 and older who have cancer that cannot be treated with surgery and have not responded well to other treatments.

To be eligible for this trial, participants must have a confirmed diagnosis of a solid tumor or lymphoma that is advanced and not suitable for surgical removal. They should also be open to trying a new treatment after not having success with existing therapies. Participants will receive the study drug in doses that may increase over time, and they will be closely monitored for any side effects. It’s important to note that women who are pregnant or breastfeeding cannot participate, and those able to become pregnant must agree to use effective birth control during the study. If you or a loved one is considering joining this trial, it could be a chance to access a new treatment option while contributing to important cancer research.

Gender

ALL

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.