Testing IBI133 in patients with advanced solid tumors

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

This study is testing a new treatment called IBI133 to see if it can help people with advanced solid tumors that can't be surgically removed.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (industry)
• Locations: 1 site (Liverpool, New South Wales)
• Trial ID: NCT06170190 on ClinicalTrials.gov

What this trial studies

This multicentre, open-label, first-in-human study evaluates IBI133 in patients with unresectable, locally advanced or metastatic solid tumors. The study consists of two phases: Phase 1 focuses on determining the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) through dose escalation and monotherapy dose expansion. Phase 2 aims to further assess the efficacy, safety, and tolerability of IBI133 at the RDE in a specified tumor population, with treatment cycles occurring every three weeks.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable, locally advanced or metastatic solid tumors that have not responded to standard treatments.

Not a fit: Patients who have previously received HER3 targeted treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.

How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in the past.

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).

Where this trial is running

Liverpool, New South Wales

• Liverpool Hospital — Liverpool, New South Wales, Australia (RECRUITING)

Study contacts

• Study coordinator: Shijie Liu

Conditions: Locally Advanced Unresectable or Metastatic Solid Tumors