Locally Advanced Unresectable or Metastatic Solid Tumors
Conditions
Brief summary
This is a multicentre, open-label, first-in-human, phase 1/2 study of IBI133 in subjects with unresectable, locally advanced or metastatic solid tumours. Phase 1 section includes three parts, IBI133 dose escalation part, and IBI133 monotherapy dose expansion part. The objective of phase 1 section is to identify MTD/recommended dose for expansion (RDE) of IBI133 monotherapy . The objective of phase 2 section is to further explore efficacy, safety and tolerability of IBI133 monotherapy at RDE in specified tumour population. The treatment cycle of the study is defined as every 3 weeks (21 days).
Interventions
BIOLOGICALIBI133
IBI133: The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the course of the study. Q3W
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. Adequate bone marrow and organ function. 6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumour that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
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. Prior HER3 targeted treatment, including but not limited to monoclonal antibody, bispecific antibody, T cell engager, and antibody-drug conjugate. 3. Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g. DS-8201).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicities (DLTs) | 21 days after the first dose of IBI133 | DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD)and /or recommended phase 2 dose (RP2D) |
| Safety: Adverse events (AEs);treatment emergent adverse event(TEAEs),serious adverse events(SAEs) | Up to 90 days after the last administration | Adverse events will be assessed by investigator(s)according to NCI-CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clearance rate(CL) | Up to 2 years | PK parameters clearance rateof IBI133,total antibody,exate can will be determined |
| half-life (T1/2) | Up to 2 years | PK parameters half-life of IBI133,total antibody,exate can will be determined |
| anti-drug antibody (ADA) | Up to 2 years | the incidence and characterization of ADA OF IBI133 will be determined |
| Preliminary efficacy including objective response rate (ORR) | Through study completion,Up to 2 years | ORR is defined as the proportion of subjects with a CR or PR. Number and percentage of subjects with CR or PR will be summarized. |
| maximum concentration (Cmax) | Up to 2 years | PK parameters maximum concentration(Cmax)of IBI133,total antibody,can will be determined |
| disease control rate (DCR) | Through study completion,Up to 2 years | DCR is defined as the proportion of subjects with a CR, PR or SD, and will be analysed in the same fashion as ORR. |
| ,time to response (TTR) | Through study completion,Up to 2 years | TTR is defined as the time from the date of first study drug to the date first achieved CR or PR based on RECIST v1.1. |
| progression free survival (PFS) | Through study completion,Up to 2 years | PFS is defined as the time from the date of first study drug to death or disease progression based on RECIST v1.1, whichever occurs first. |
| duration of response (DoR) | Through study completion,Up to 2 years | DoR is defined as the time from the date first achieved CR or PR until the date of first documents disease progression based on RECIST v1.1 or death |
| area under the curve (AUC) | Up to 2 years | PK parameters clearance rate of IBI133,total antibody,exate can will be determined |
Countries
Australia
Outcome results
None listed