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)
Numbers of subjects with adverse events — Up to 3 years defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with clinically significant changes in physical examination results — Up to 3 years Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in electrocardiogram — Up to 3 years Clinically significant abnormal electrocardiogram findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs — Up to 3 years Vital signs including body temperature, pulse, respiratory rate, oxygen saturation by pulse oximetry at rest and blood pressure
Dose limiting toxicities (DLTs) — Up to 21 days Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
objective response rate (ORR) — Up to 3 years objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Number of subjects with clinically significant changes in laboratory parameters — Up to 3 years Clinically significant abnormal laboratory parameters findings reported by the investigator.
Trial sites (9)
Facility
City
Region
Status
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
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.
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