Testing IBI130 for patients with advanced solid tumors

A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

This study is testing a new treatment called IBI130 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: 182 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 1 site (Birtinya, Queensland)
• Trial ID: NCT05923008 on ClinicalTrials.gov

What this trial studies

This is a phase 1/2 multicenter, open-label clinical trial evaluating IBI130 in patients with unresectable, locally advanced, or metastatic solid tumors. The study consists of a dose escalation and expansion phase to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of IBI130, followed by a phase 2 assessment of its efficacy, safety, and tolerability in approximately 150 evaluable subjects. The trial aims to enroll between 20 to 182 subjects in total.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable, locally advanced, or metastatic solid tumors and an ECOG performance status of 0 or 1.

Not a fit: Patients who have received anti-tumor therapy within the last 4 weeks or those who plan to receive other anti-tumor therapies during the study may not benefit from this trial.

Why it matters

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

How similar studies have performed: Other studies have shown promise with similar investigational therapies, but this specific approach with IBI130 is novel.

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

Exclusion Criteria:

1. Enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study;
2. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter;
3. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
4. Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;

Where this trial is running

Birtinya, Queensland

• Sunshine Coast University — Birtinya, Queensland, Australia (Recruiting)

Study contacts

• Study coordinator: Serena Dong

Conditions Solid Tumor