Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Launched by INNOVENT BIOPHARMACEUTICAL TECHNOLOGY (HANGZHOU) CO., LTD. · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IBI3020 for patients with certain types of solid tumors that cannot be surgically removed and may have spread to other parts of the body. The main goal of the study is to find out how safe IBI3020 is and to determine the highest dose that can be given without causing serious side effects. The trial is currently not recruiting participants, but it will include adults aged 18 and older, specifically those with confirmed advanced solid tumors and at least one measurable tumor.

To participate, individuals must be in good enough health to give informed consent and have a life expectancy of at least 12 weeks. They should not have received certain previous cancer treatments or have significant health issues that could interfere with the study. If eligible, participants will receive IBI3020 and will be monitored closely for any side effects. This trial could help researchers learn more about this treatment and how it might help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants must satisfy all of the following criteria to be enrolled into the study:
• • 1. Participants 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 participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;
• 3. Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors:
• • 4. At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;
• • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
• • 6. Minimum life expectancy of 12 weeks;
• • 7. Adequate bone marrow and organ function confirmed at screening period,
• • 8. Participants, both male and female, who are not of childbearing potential or who agree to useat least 1 highly effective method of contraception during the study
• Exclusion Criteria:
• Participants who meet any of the following criteria will be disqualified from entering the study:
• • 1. Previous treatment with CEACAM5-targeted therapy, or previous treatment with an ADC with a TOPO1 payload AND an ADC with an MMAE payload;
• • 2. Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
• 3. Prior anti-cancer therapy:
• • 4. Received live vaccines within 4 weeks or cancer vaccine within 3 months prior to the first dose of the study drug or plan on receiving any live vaccine during the study;
• • 5. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives prior to the first dose of the study drug, whichever is shorter;
• • 6. Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0
• • 7. Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients (refer to Investigator's Brochure);
• • 8. Undergone major surgery (craniotomy, thoracotomy or laparotomy, and other surgery according to investigator's 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.;
• • 9. Known symptomatic central nervous system (CNS) metastases
• 10. Uncontrolled diseases or conditions including:
• • 11. History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases (e.g., interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease such as pulmonary fibrosis, severe radiation pneumonitis and acute lung injury) or who are suspected to have these diseases by imaging at screening period;
• • 12. History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina pectoris, cerebrovascular stroke or transient ischemic attack, etc.;
• • 13. Under neurological, psychiatric or social condition that affects compliance with study requirements, significantly increases the risk of adverse events, or affects participants' ability to provide written informed consent;
• • 14. Women who are pregnant, have positive results in pregnancy test or are lactating;
• • 15. Not eligible to participate in this study at the discretion of the investigator.