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Recruiting Phase 1

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

NCT06963281 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2025-04-29
Last updated
2026-09-25

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)

  • 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)

FacilityCityRegionStatus
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
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