IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Apr 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IBI3001 for people with advanced solid tumors that cannot be surgically removed. The goal of the study is to find the highest safe dose of IBI3001 and to see if it helps improve the condition of patients who have not responded well to standard treatments. The trial is currently recruiting participants aged 18 and older, who have a good performance status (meaning they can carry out daily activities with little difficulty) and a life expectancy of at least 12 weeks. To join, participants must have a specific type of advanced solid tumor that is either resistant to standard therapies or for which no standard treatment is available.

If you decide to participate, you will receive the study drug and be monitored closely for any effects. The researchers will also assess your tumor to see if the treatment is working. It’s important to note that certain health conditions, such as active central nervous system issues or significant lung diseases, may prevent you from joining the study. Overall, this trial aims to explore a new option for patients facing limited treatment choices for their advanced solid tumors.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Male or female participants ≥ 18 years old;
• • 2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
• • 3. Has an anticipated life expectancy of ≥ 12 weeks;
• 4. Adequate bone marrow and organ function:
• • 5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
• • 6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.
• Key Exclusion Criteria:
• • 1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
• • 2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
• • 3. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
• • 4. Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
• • 5. Known symptomatic central nervous system (CNS) metastases.
• • 6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
• • 7. History of endotracheal or gastrointestinal stent implantation;
• • 8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
• • 9. Esophageal or gastric varices requiring immediate intervention;
• • 10. Not eligible to participate in this study at the discretion of the investigator;
• • 11. Do not have adequate treatment washout period before study drug administration. -