Advanced Solid Tumors
Conditions
Brief summary
This is open-label, multicenter, Phase I/II study is designed to evaluate the Safety and tolerability and Efficacy of IBI334 Monotherapy in participants with advanced solid tumors.
Interventions
DRUGIBI334
There are six dose of IBI334 ,QW IV in first cycle and Q2W IV behind the first cycle
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
： 1. Subjects with 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 subjects ≥ 18 years old; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 4. Anticipated life expectancy of ≥ 12 weeks; 5. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1with Phase Ia ;At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with Phase Ib+II；
Exclusion criteria
： 1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study; 2. Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study; 3. History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases; 4. Severe allergic or hypersensitive to other EGFR or B7H3 antibodies or any ingredients of IBI334; 5. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief, which must not affect tumor assessment throughout the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with treatment-related adverse events | Up to 60 days post last dose |
| Percentage of subjects woth Dose-Limitine toxicities(DLTs) | Up to 28 days following first dose |
Secondary
| Measure | Time frame |
|---|---|
| PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: clearance (CL) | Day 1 up to treatment duration reaches 24 months |
| PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: apparent volume of distribution (V) | Day 1 up to treatment duration reaches 24 months |
| PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: half-life (t1/2). | Day 1 up to treatment duration reaches 24 months |
| Prevalence and incidence of anti-IBI334 antibodies. | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy ： objective response rate (ORR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Day 1 up to treatment duration reaches 24 months |
| PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: area under the curve (AUC) | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy : disease control rate (DCR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy :time to response (TTR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy :progression-free survival (PFS) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy :overall survival (OS) | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy : duration of response (DoR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Day 1 up to treatment duration reaches 24 months |
| PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to:maximum concentration (Cmax) | Day 1 up to treatment duration reaches 24 months |
Countries
China
Outcome results
None listed