IBI3026 for locally advanced, unresectable, or metastatic solid tumors

A Multi-Center, Open-Label, Phase 1 Study of IBI3026 in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors

This trial tests IBI3026 in adults with solid tumors that are locally advanced, cannot be removed, or have spread to find safe doses and see if it can shrink tumors or slow their growth.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) (Industry-sponsored)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07327632 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter Phase 1 dose-escalation and expansion trial of the investigational agent IBI3026 in adults with unresectable, locally advanced, or metastatic solid tumors. The first part uses a standard dose-escalation design to identify tolerated dose levels, followed by expansion cohorts at selected doses to characterize safety and preliminary anti-tumor activity. Safety will be overseen by a Safety Review Committee and participants must have measurable disease and good organ function. The study enrolls adults with ECOG 0-1 who are not candidates for curative surgery or definitive chemoradiotherapy.

Who should consider this trial

Good fit: Adults (≥18 years) with measurable, unresectable, locally advanced or metastatic solid tumors, ECOG performance status 0-1, adequate organ and bone marrow function, life expectancy ≥12 weeks, and not eligible for curative surgery or definitive chemoradiotherapy are the intended candidates.

Not a fit: Patients who have poor performance status (ECOG >1), inadequate organ function, a life expectancy under 12 weeks, or prior exposure to the same investigational agent (IBI3026) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, IBI3026 could provide a new treatment option that stabilizes or shrinks advanced solid tumors with an acceptable safety profile.

How similar studies have performed: Early-phase trials of other investigational biologics for advanced solid tumors have occasionally shown tumor responses, but IBI3026 itself is novel and unproven in humans at this stage.

Eligibility criteria

inclusion criteria:

1. Participants must have the ability to understand and sign a written informed consent form for participation in this study, including all assessments and procedures specified in the protocol;
2. Male or female participants aged ≥18 years;
3. At least one measurable lesion as defined by RECIST v1.1 within 28 days prior to the first dose of IBI3026;
4. ECOG performance status of 0-1;
5. Life expectancy of at least 12 weeks at the start of treatment;
6. The screening period confirms that bone marrow and organ functions are good.
7. Male or female participants who are either of non-reproductive potential or agree to use at least one highly effective method of contraception during the study period (starting from screening or 2 weeks prior to first dosing, whichever comes first, and continuing until 6 months after the last dose of study drug);
8. Not amenable to curative surgical resection or definitive chemoradiotherapy.

Exclusion criteria:

1. Prior treatment with IL-12 class cytokines or IL-12 inhibitors;
2. Participation in any interventional clinical study other than observational (non-interventional) studies, or currently in the follow-up period of an interventional study;
3. Adverse reactions from prior anti-tumor therapies that have not resolved to Grade 0 or 1, or baseline levels, according to NCI CTCAE v5.0, prior to the first dose of study drug (exceptions include alopecia, fatigue, hyperpigmentation, or other conditions deemed without safety risk by the investigator);
4. Prior immune checkpoint inhibitor therapy associated with severe adverse reactions sufficient to compromise participant safety;
5. Known hypersensitivity, allergic reaction, or intolerance to IBI3026 or its excipients (refer to Investigator's Brochure).
6. Received major surgery (e.g., craniotomy, thoracotomy, or laparotomy, or other surgeries as determined by the investigator) within 4 weeks prior to the first dose of study drug, excluding core biopsy; or anticipated to undergo major surgery during the study period; or presence of serious non-healing wounds, trauma, ulcers, etc.
7. Known symptomatic central nervous system (CNS) metastases. Participants with asymptomatic CNS metastases (i.e., no neurological syndrome and metastatic lesion diameter ≤1.5 cm) or those with stable disease post-treatment as judged by the investigator may be considered under the following conditions: absence of midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord involvement; clinically stable for at least 4 weeks prior to the first dose of study drug (stable on ≤1.5 mg/day dexamethasone or equivalent corticosteroid and baseline anticonvulsant therapy), with no clinically confirmed new or enlarging CNS lesions.
8. Tumor invasion into surrounding critical structures (e.g., mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal/respiratory fistula formation.

Where this trial is running

Chengdu, Sichuan

• Sichuan Cancer Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Haiyun Zuo

Conditions Solid Tumor