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

A Multicentre, Open-label, Phase 1/2 Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours

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).

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Unresectable or Metastatic Solid Tumors
• Intervention / Treatment: Biological: IBI133

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shijie Liu; Phone Number: +86 18701121959; Email: shijie.liu@innoventbio.com

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Recruiting
      • Liverpool Hospital
      • Contact: Kate Wilkinson; Phone Number: 02 9382 5800; Email: lisa.nelson@scientiaclinicalresearch.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label：IBI133 monotherapy	Biological: IBI133; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose limiting toxicities (DLTs)	DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD)and /or recommended phase 2 dose (RP2D)	21 days after the first dose of IBI133
Safety: Adverse events (AEs);treatment emergent adverse event(TEAEs),serious adverse events(SAEs)	Adverse events will be assessed by investigator(s)according to NCI-CTCAE v5.0	Up to 90 days after the last administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum concentration (Cmax)	PK parameters maximum concentration(Cmax)of IBI133,total antibody,can will be determined	Up to 2 years
area under the curve (AUC)	PK parameters clearance rate of IBI133,total antibody,exate can will be determined	Up to 2 years
clearance rate(CL)	PK parameters clearance rateof IBI133,total antibody,exate can will be determined	Up to 2 years
half-life (T1/2)	PK parameters half-life of IBI133,total antibody,exate can will be determined	Up to 2 years
anti-drug antibody (ADA)	the incidence and characterization of ADA OF IBI133 will be determined	Up to 2 years
Preliminary efficacy including objective response rate (ORR)	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.	Through study completion,Up to 2 years
duration of response (DoR)	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	Through study completion,Up to 2 years
disease control rate (DCR)	DCR is defined as the proportion of subjects with a CR, PR or SD, and will be analysed in the same fashion as ORR.	Through study completion,Up to 2 years
,time to response (TTR)	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.	Through study completion,Up to 2 years
progression free survival (PFS)	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.	Through study completion,Up to 2 years

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI133A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No