Testing IBI3004 for advanced solid tumors

A Phase 1/2, Multicenter, Open-label Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

This study is testing a new treatment called IBI3004 to see if it can help people with advanced solid tumors that can't be removed by surgery.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 5 sites (Randwick, New South Wales and 4 other locations)
• Trial ID: NCT06198426 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter study evaluating the safety and efficacy of IBI3004 in patients with unresectable, locally advanced, or metastatic solid tumors. The study consists of a dose escalation phase to determine the Maximum Tolerated Dose (MTD) and a subsequent expansion phase for selected dose levels. Utilizing an accelerated titration and Bayesian Optimal Interval (BOIN) design, the study aims to enroll up to 46 participants initially, with further expansion for each selected dose group to include 30 subjects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable solid tumors and an ECOG performance status of 0 or 1.

Not a fit: Patients who have recently received anti-tumor therapies or those with a life expectancy of less than 12 weeks 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: Other studies using similar dose escalation methods have shown promise, but the specific application of IBI3004 is novel.

Eligibility criteria

Inclusion Criteria:

1. Subjects have 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. For Part 1, age ≥18 and ≤75 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 21 days of monoclonal antibodies or cytotoxic therapy prior to the first dose of the study drug, or within 14 days of small molecule targeted drugs prior to the first dose of the study drug. Received palliative radiation therapy within 2 weeks prior to the first dose of the study drug, or received radical radiation therapy within 4 weeks prior to the first dose of the study drug;
3. Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;
4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.

Where this trial is running

Randwick, New South Wales and 4 other locations

• Scientia Clinical Research Ltd — Randwick, New South Wales, Australia (Terminated)
• Liverpool Hospital — Sydney, New South Wales, Australia (Terminated)
• Westmead Hospital — Sydney, New South Wales, Australia (Terminated)
• Jiang Su Province Hospital — Nanjing, Jiangsu, China (Recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Serena Dong

Conditions Solid Tumor