A Study of IBI363 in Subjects with Advanced Solid Malignancies

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Feb 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called IBI363 to see how well it works in treating patients with advanced solid tumors, which are types of cancers that form in tissues like organs. This is a Phase 2 trial, meaning it's focused on understanding the drug’s effectiveness and safety in a larger group of patients. The trial is currently recruiting participants who are 18 years or older and are in good enough health to participate, meaning they can perform daily activities without significant issues.

To be eligible, participants should have a life expectancy of at least three months and should not have had certain recent cancer treatments or surgeries. If someone joins the study, they can expect to receive the study drug and be monitored closely for its effects and any side effects. It’s important to know that patients will need to provide written consent to participate and must meet specific health criteria to ensure their safety during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
• • 2. Male or female subjects ≥ 18 years old;
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
• • 4. Anticipated life expectancy of ≥ 3 months;
• Exclusion Criteria:
• • 1. Inadequate bone marrow and organ function;
• • 2. Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose
• • 3. Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
• • 4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
• • 5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.