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Clinical Trials in China / NCT06963281
Recruiting Phase 1

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

NCT06963281 · tracked via the Priya Life Science China tracker
Sponsor
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Phase
Phase 1
Started
2025-04-29
Last updated
2025-06-06

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

IBI3020

IBI3020: Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Mayo Clinic - Arizona Pheonix Arizona Recruiting
Mayo Clinic - Florida Jacksonville Florida Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
Montefiore Cancer Center New York New York Recruiting
NEXT Houston Houston Texas Recruiting
NEXT Dallas Irving Texas Recruiting
The sixth affiliated hospital, Sun Yat-sen University Guangzhou Guangdong Recruiting
Shandong Cancer Hospital Jinan Shandong Recruiting
Shanxi Cancer Hospital Taiyuan Shanxi Recruiting

More Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06963281 on ClinicalTrials.gov ↗ ← All trials in China