Clinical trial NCT06963281: Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors
Official title: A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Sponsor class: INDUSTRY
Collaborators: name: Fortvita Biologics (USA)Inc.
First posted: 2025-05-08
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Numbers of subjects with adverse events
timeFrame: Up to 3 years
measure: Number of subjects with clinically significant changes in physical examination results
timeFrame: Up to 3 years
measure: Number of subjects with clinically significant changes in electrocardiogram
timeFrame: Up to 3 years
measure: Number of subjects with clinically significant changes in vital signs
timeFrame: Up to 3 years
measure: Dose limiting toxicities (DLTs)
timeFrame: Up to 21 days
measure: objective response rate (ORR)
timeFrame: Up to 3 years
measure: Number of subjects with clinically significant changes in laboratory parameters
timeFrame: Up to 3 years
Secondary outcomes:
measure: area under the curve (AUC)
timeFrame: Up to 3 years
measure: maximum concentration (Cmax)
timeFrame: Up to 3 years
measure: time to maximum concentration (Tmax)
timeFrame: Up to 3 years
measure: clearance (CL)
timeFrame: Up to 3 years
measure: apparent volume of distribution (V)
timeFrame: Up to 3 years
measure: half-life (t1/2)
timeFrame: Up to 3 years
measure: anti-drug antibody (ADA)
timeFrame: Up to 3 years
measure: objective response rate (ORR)
timeFrame: Up to 3 years
measure: duration of response (DoR)
timeFrame: Up to 3 years
measure: time to response (TTR)
timeFrame: Up to 3 years
measure: progression free survival (PFS)
timeFrame: Up to 3 years
measure: disease control rate (DCR)
timeFrame: Up to 3 years
measure: overall survival (OS)
timeFrame: From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months
Other outcomes:
Locations:
city: Pheonix
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic - Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: New york
country: United States
facility: Montefiore Cancer Center
state: New York
city: Houston
country: United States
facility: NEXT Houston
state: Texas
city: Irving
country: United States
facility: NEXT Dallas
state: Texas
city: Guangzhou
country: China
facility: The sixth affiliated hospital, Sun Yat-sen University
state: Guangdong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
Study officials:
References: