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NCT Number: NCT06170190

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

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).

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Key information

Conditions

Locally Advanced Unresectable or Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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).

Treatment and study plan

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

Primary outcomes

  1. Dose limiting toxicities (DLTs)

    Time frame: 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)

  2. Safety: Adverse events (AEs);treatment emergent adverse event(TEAEs),serious adverse events(SAEs)

    Time frame: Up to 90 days after the last administration

    Adverse events will be assessed by investigator(s)according to NCI-CTCAE v5.0

Secondary outcomes

  1. maximum concentration (Cmax)

    Time frame: Up to 2 years

    PK parameters maximum concentration(Cmax)of IBI133,total antibody,can will be determined

  2. area under the curve (AUC)

    Time frame: Up to 2 years

    PK parameters clearance rate of IBI133,total antibody,exate can will be determined

  3. clearance rate(CL)

    Time frame: Up to 2 years

    PK parameters clearance rateof IBI133,total antibody,exate can will be determined

  4. half-life (T1/2)

    Time frame: Up to 2 years

    PK parameters half-life of IBI133,total antibody,exate can will be determined

  5. anti-drug antibody (ADA)

    Time frame: Up to 2 years

    the incidence and characterization of ADA OF IBI133 will be determined

  6. Preliminary efficacy including objective response rate (ORR)

    Time frame: 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.

  7. duration of response (DoR)

    Time frame: 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

  8. disease control rate (DCR)

    Time frame: 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.

  9. ,time to response (TTR)

    Time frame: 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.

  10. progression free survival (PFS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 14, 2023
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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