Solid Tumor
Conditions
Brief summary
This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22\ 180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for phase 2
Interventions
DRUGIBI129
Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.
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. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.; 3. Male or female subjects ≥ 18 years old; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 5. Anticipated life expectancy of ≥ 12 weeks; 6. Adequate bone marrow and organ function
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 previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter. 3. Progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor. 4. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study; 5. Known symptomatic central nervous system (CNS) metastases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | 24 months | Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria |
| Number of subjects with clinically significant changes in physical examination results | 24 months | Clinically significant abnormal physical examination findings reported by the investigator. |
| Number of subjects with clinically significant changes in vital signs | 24 months | Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure |
| MTD or RP2D of IBI129 | 12 months | Number of subjects with dose-limiting toxicities (DLTs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration (Cmax) of IBI129 | 12 months | Plasma concentration of IBI129 for single and multiple doses. |
| Area under the curve (AUC) of IBI129 | 12 months | AUC of IBI129 for single and multiple doses. |
| Time to maximum concentration (Tmax) of IBI129 | 12 months | Tmax of IBI129 for single and multiple doses. |
| Clearance (CL) of IBI129 | 12 months | Clearance of IBI129 from the plasma |
| Volume of distribution (V) of IBI129 | 12 months | Apparent volume of distribution of IBI129. |
| Half-life (T1/2) of IBI129 | 12 months | T1/2 of IBI129 for single and multiple doses. |
| Immunogenicity of IBI129 | 12 months | Incidence of anti-drug (IBI129) antibody |
| Objective response rate (ORR) | 24 months | ORR as evaluated per the RECIST v1.1 criteria |
| Duration of response (DoR) | 24 months | DoR as evaluated per the RECIST v1.1 criteria |
| Disease control rate (DCR) | 24 months | DCR as evaluated per the RECIST v1.1 criteria |
| Time to response (TTR) | 24 months | TTR as evaluated per the RECIST v1.1 criteria |
| Progression free survival (PFS) | 24 months | PFS as evaluated per the RECIST v1.1 criteria |
| Overall survival (OS) | 24 months | Overall survival. |
Countries
Australia, China
Outcome results
None listed