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

NCT07327632 | Recruiting Early Phase 1 DMC

• 1 other identifier: CIBI3026A101
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Adverse Event

  up to 2 years

• Serious Adverse Event

  up to 2 years

• Maximum Tolerated Dose

  up to 2 years

• DLT(Dose-limiting Toxicity)

  up to 2 years

Secondary Outcomes (9)

• PK concentration: IBI3026 serum concentration

  up to 2 years

• Incidence and number of patients with ADA

  up to 2 years

• Incidence and number of patients with NAb

  up to 2 years

• ORR (Objective Response Rate)

  up to 2 years

• DoR(Duration of Response)

  up to 2 years

Study Arms (1)

IBI3026

EXPERIMENTAL

Drug: IBI3026

Interventions

IBI3026 DRUG

Recombinant anti-programmed death receptor-1 (PD-1) antibody fused with interleukin-12 (IL-12) bispecific molecule injection

IBI3026

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Innovent Biologics Technology Limited (Shanghai R&D Center): lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Central Study Contacts

Haiyun Zuo

CONTACT

021-31852088; Haiyun.zuo@innoventbio.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 8, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

CN (1)