Solid Tumors
Conditions
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.
Interventions
DRUGIBI3020
Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection
Sponsors
Fortvita Biologics (USA)Inc.
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| apparent volume of distribution (V) | Up to 3 years | apparent volume of distribution (V) of single and multiple doses of IBI3020 |
| half-life (t1/2) | Up to 3 years | half-life (t1/2) of IBI3020 to the last administration of IBI3020 |
| anti-drug antibody (ADA) | Up to 3 years | Incidence and characterization of anti-drug antibody (ADA). |
| time to response (TTR) | Up to 3 years | time to response (TTR) as evaluated per the RECIST v1.1 criteria. |
| duration of response (DoR) | Up to 3 years | duration of response (DoR) as evaluated per the RECIST v1.1 criteria. |
| overall survival (OS) | From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months | OS is defined as the time from the date of first dose of study drug until the date of death from any cause. |
| objective response rate (ORR) | Up to 3 years | objective response rate (ORR) as evaluated per the RECIST v1.1 criteria. |
| progression free survival (PFS) | Up to 3 years | as evaluated per the RECIST v1.1 criteria. |
| disease control rate (DCR) | Up to 3 years | disease control rate (DCR)as evaluated per the RECIST v1.1 criteria. |
| area under the curve (AUC) | Up to 3 years | area under the curve (AUC) of single and multiple doses of IBI3020 |
| maximum concentration (Cmax) | Up to 3 years | maximum concentration (Cmax) of single and multiple doses of IBI3020 |
| time to maximum concentration (Tmax) | Up to 3 years | time to maximum concentration (Tmax) of single and multiple doses of IBI3020 |
| clearance (CL) | Up to 3 years | clearance (CL) of single and multiple doses of IBI3020 |
Countries
China, United States
Contacts
Primary ContactSerena Dong
Outcome results
None listed