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

Purpose

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.

Condition

  • Solid Tumors

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IBI3020
  • Drug: IBI3020
    Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection

Recruiting Locations

Mayo Clinic - Arizona
Pheonix, Arizona 5551752 85054
Contact:
Mitesh Borad, Dr
480-301-8000
Borad.Mitesh@mayo.edu

Mayo Clinic - Florida
Jacksonville 4160021, Florida 4155751 32224
Contact:
Yanyan Lou, Dr.
(480) 342-2000
Lou.Yanyan@mayo.edu

Mayo Clinic - Rochester
Rochester 5043473, Minnesota 5037779 55905
Contact:
Hao Xie, Dr
(507) 512-1667
Xie.Hao@mayo.edu

Montefiore Cancer Center
New York 5128581, New York 5128638 10461
Contact:
Fernand Bteich, Dr.
(718) 405-8124
fbteich@montefiore.org

NEXT Houston
Houston 4699066, Texas 4736286 77054
Contact:
Jennifer Segar
832-384-7900
jsegar@nextoncology.com

NEXT Dallas
Irving 4700168, Texas 4736286 75039
Contact:
Shiraj Sen
972-893-8800
ssen@nextoncology.com

More Details

NCT ID
NCT06963281
Status
Recruiting
Sponsor
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Study Contact

Serena Dong
051269566088
suhua.dong@innoventbio.com