Clinical Trials in the USA / NCT06963281
Recruiting
Phase 1
Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors
NCT06963281 · tracked via the Priya Life Science USA tracker
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
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 | Phoenix | 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 Fortvita Biologics (USA)Inc. trials in the USA
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A Study of IBI3032 in Healthy Participants
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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 the USA