This is a Multi-Center Study of IBI3026 in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors

Recruiting now · Early Phase 1

Conditions studied: Solid Tumor

In brief

This is a multicenter, open-label, phase I dose-escalation and expansion study of IBI3026 in participants with unresectable, locally advanced, or metastatic solid tumors. The study will be conducted in two phases: Phase 1 dose escalation and Phase 2 dose expansion. Safety will be monitored by the Safety Review Committee (SRC).

Key facts

Study ID

NCT07327632

Run by

Innovent Biologics Technology Limited (Shanghai R&D Center)

People needed

300

Starts

2026-01-29

Expected to finish

2028-12-31

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Male or female participants aged ≥18 years;
• At least one measurable lesion as defined by RECIST v1.1 within 28 days prior to the first dose of IBI3026;
• ECOG performance status of 0-1;
• Life expectancy of at least 12 weeks at the start of treatment;
• The screening period confirms that bone marrow and organ functions are good.
• 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);
• Not amenable to curative surgical resection or definitive chemoradiotherapy.

You may not qualify if…

• Prior treatment with IL-12 class cytokines or IL-12 inhibitors;
• Participation in any interventional clinical study other than observational (non-interventional) studies, or currently in the follow-up period of an interventional study;
• 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);
• Prior immune checkpoint inhibitor therapy associated with severe adverse reactions sufficient to compromise participant safety;
• Known hypersensitivity, allergic reaction, or intolerance to IBI3026 or its excipients (refer to Investigator's Brochure).
• 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.
• 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.
• 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 it is running

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

Full record on ClinicalTrials.gov

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