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NCT06963281PHASE1Recruiting

Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Start Date

4/29/2025

Completion Date

3/31/2028

Summary

The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.

Eligibility Criteria

Age Range: 18 years to 75 years

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 which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications; 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 use at 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; 2. Prior anti-cancer therapy within the wash-out period; 3. Received live vaccines within 4 weeks or cancer vaccine within 3 months; 4. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives; 5. 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; 6. Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients; 7. Undergone major surgery within 4 weeks, or who have severe unhealed wounds; 8. Known symptomatic central nervous system (CNS) metastases; 9. Uncontrolled diseases or conditions; 10. History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases; 11. History of thromboembolic event within 6 months; 12. Under neurological, psychiatric or social condition; 13. Women who are pregnant, have positive results in pregnancy test or are lactating; 14. Not eligible to participate in this study at the discretion of the investigator; 15. Participating in any other interventional clinical research.

Interventions

DRUG

IBI3020

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Conditions

Solid Tumors

Locations

Mayo Clinic - Arizona

Pheonix, Arizona 85054

United States

Mayo Clinic - Florida

Jacksonville, Florida 32224

United States

Mayo Clinic - Rochester

Rochester, Minnesota 55905

United States

Montefiore Cancer Center

New York, New York 10461

United States

NEXT Houston

Houston, Texas 77054

United States

NEXT Dallas

Irving, Texas 75039

United States

The sixth affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong

China

Shandong Cancer Hospital

Jinan, Shandong

China

Shanxi Cancer Hospital

Taiyuan, Shanxi

China