A Multicentre,Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours

Phase 1

Recruiting

• Conditions: Locally Advanced Unresectable or Metastatic Solid Tumors

• Registration Number: NCT06170190
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Study Start: 2024-01-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
half-life (T1/2)	Up to 2 years	PK parameters half-life of IBI133,total antibody,exate can will be determined
maximum concentration (Cmax)	Up to 2 years	PK parameters maximum concentration(Cmax)of IBI133,total antibody,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.
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.
area under the curve (AUC)	Up to 2 years	PK parameters clearance rate of IBI133,total antibody,exate can will be determined
clearance rate(CL)	Up to 2 years	PK parameters clearance rateof IBI133,total antibody,exate can will be determined
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
,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.
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.

Trial Locations

Locations (1)

Liverpool Hospital; 🇦🇺 Liverpool, New South Wales, Australia