A Study of IBI129 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors
- Registration Number
- NCT05991349
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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;
- At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.;
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function
- Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
- 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.
- Progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor.
- 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;
- Known symptomatic central nervous system (CNS) metastases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IBI129 IBI129 IBI129
- Primary Outcome Measures
Name Time Method MTD or RP2D of IBI129 12 months Number of subjects with dose-limiting toxicities (DLTs)
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
- Secondary Outcome Measures
Name Time Method Volume of distribution (V) of IBI129 12 months Apparent volume of distribution of IBI129.
Duration of response (DoR) 24 months DoR as evaluated per the RECIST v1.1 criteria
Progression free survival (PFS) 24 months PFS as evaluated per the RECIST v1.1 criteria
Area under the curve (AUC) of IBI129 12 months AUC of IBI129 for single and multiple doses.
Plasma concentration (Cmax) of IBI129 12 months Plasma concentration of IBI129 for single and multiple doses.
Time to maximum concentration (Tmax) of IBI129 12 months Tmax of IBI129 for single and multiple doses.
Immunogenicity of IBI129 12 months Incidence of anti-drug (IBI129) antibody
Clearance (CL) of IBI129 12 months Clearance of IBI129 from the plasma
Half-life (T1/2) of IBI129 12 months T1/2 of IBI129 for single and multiple doses.
Objective response rate (ORR) 24 months ORR as evaluated per the RECIST v1.1 criteria
Time to response (TTR) 24 months TTR as evaluated per the RECIST v1.1 criteria
Disease control rate (DCR) 24 months DCR as evaluated per the RECIST v1.1 criteria
Overall survival (OS) 24 months Overall survival.
Trial Locations
- Locations (7)
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Wollongong Hospital
🇦🇺Wollongong, New South Wales, Australia
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Tianjin Medical university cancer institute & Hospital
🇨🇳Tianjin, Tianjin, China
St George private Hospital
🇦🇺Kogarah, New South Wales, Australia