A Multicentre,Study of IBI133 in Subjects WithUnresectable, Locally Advanced or Metastatic SolidTumours

NCT06170190 | Completed Phase 1

• 1 other identifier: CIBI133A101
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Locally Advanced Unresectable or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• maximum concentration (Cmax)

  Up to 2 years

• area under the curve (AUC)

  Up to 2 years

• clearance rate(CL)

  Up to 2 years

• half-life (T1/2)

  Up to 2 years

• anti-drug antibody (ADA)

  Up to 2 years

Study Arms (1)

Open-label：IBI133 monotherapy

EXPERIMENTAL

Biological: IBI133

Interventions

IBI133 BIOLOGICAL

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

Open-label：IBI133 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.
• 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;

You may not qualify if:

• Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
• Prior HER3 targeted treatment, including but not limited to monoclonal antibody, bispecific antibody, T cell engager, and antibody-drug conjugate.
• Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g. DS-8201).

Sponsors & Collaborators

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

Study Sites (1)

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 14, 2023
• Study Start: January 16, 2024
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

AU (1)