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RecruitingInterventionalPhase 1

A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

NCT ID: NCT06963281Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.Last updated: 2025-06-06

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.

Arms & interventions

  • DrugIBI3020

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

Outcome measures

Primary

  • Numbers of subjects with adverse events

    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

    Time frame: Up to 3 years

  • Number of subjects with clinically significant changes in physical examination results

    Clinically significant abnormal physical examination findings reported by the investigator.

    Time frame: Up to 3 years

  • Number of subjects with clinically significant changes in electrocardiogram

    Clinically significant abnormal electrocardiogram findings reported by the investigator.

    Time frame: Up to 3 years

  • Number of subjects with clinically significant changes in vital signs

    Vital signs including body temperature, pulse, respiratory rate, oxygen saturation by pulse oximetry at rest and blood pressure

    Time frame: Up to 3 years

  • Dose limiting toxicities (DLTs)

    Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.

    Time frame: Up to 21 days

  • objective response rate (ORR)

    objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.

    Time frame: Up to 3 years

  • Number of subjects with clinically significant changes in laboratory parameters

    Clinically significant abnormal laboratory parameters findings reported by the investigator.

    Time frame: Up to 3 years

Secondary

  • area under the curve (AUC)

    Time frame: Up to 3 years

  • maximum concentration (Cmax)

    Time frame: Up to 3 years

  • time to maximum concentration (Tmax)

    Time frame: Up to 3 years

  • clearance (CL)

    Time frame: Up to 3 years

  • apparent volume of distribution (V)

    Time frame: Up to 3 years

  • half-life (t1/2)

    Time frame: Up to 3 years

  • anti-drug antibody (ADA)

    Time frame: Up to 3 years

  • objective response rate (ORR)

    Time frame: Up to 3 years

  • duration of response (DoR)

    Time frame: Up to 3 years

  • time to response (TTR)

    Time frame: Up to 3 years

  • progression free survival (PFS)

    Time frame: Up to 3 years

  • disease control rate (DCR)

    Time frame: Up to 3 years

  • overall survival (OS)

    Time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months

Eligibility criteria

Sex: AllAge: 18 Years to 75 YearsHealthy 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.

Study locations (6)

Mayo Clinic - Arizona

Pheonix, Arizona, 85054

Recruiting
Mitesh Borad, Dr · Contact

Mayo Clinic - Florida

Jacksonville, Florida, 32224

Recruiting
Yanyan Lou, Dr. · Contact

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Recruiting
Hao Xie, Dr · Contact

Montefiore Cancer Center

New York, New York, 10461

Recruiting
Fernand Bteich, Dr. · Contact

NEXT Houston

Houston, Texas, 77054

Recruiting
Jennifer Segar · Contact

NEXT Dallas

Irving, Texas, 75039

Recruiting