Clinical trial NCT06170190: A Multicentre,Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours
Official title: A Multicentre, Open-label, Phase 1/2 Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Locally Advanced Unresectable or Metastatic Solid Tumors
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Dose limiting toxicities (DLTs)
timeFrame: 21 days after the first dose of IBI133
measure: Safety: Adverse events (AEs);treatment emergent adverse event(TEAEs),serious adverse events(SAEs)
timeFrame: Up to 90 days after the last administration
Secondary outcomes:
measure: maximum concentration (Cmax)
timeFrame: Up to 2 years
measure: area under the curve (AUC)
timeFrame: Up to 2 years
measure: clearance rate(CL)
timeFrame: Up to 2 years
measure: half-life (T1/2)
timeFrame: Up to 2 years
measure: anti-drug antibody (ADA)
timeFrame: Up to 2 years
measure: Preliminary efficacy including objective response rate (ORR)
timeFrame: Through study completion,Up to 2 years
measure: duration of response (DoR)
timeFrame: Through study completion,Up to 2 years
measure: disease control rate (DCR)
timeFrame: Through study completion,Up to 2 years
measure: ,time to response (TTR)
timeFrame: Through study completion,Up to 2 years
measure: progression free survival (PFS)
timeFrame: Through study completion,Up to 2 years
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
Study officials:
References: