Ireland
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Starting soon Phase 1

A Study of IBI3043 Treatment in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors

NCT07902804 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2026-11-16
Last updated
2026-10-29

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

IBI3043

IBI3043: IBI3043 is an investigational drug administered as Q2W or Q3W according to the study protocol.

Study summary

This is a multicenter, open-label, phase I dose-escalation and expansion study of IBI3043 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 IBI3043; * 4\. ECOG performance status of 0-1; * 5\. Life expectancy of at least 12 weeks at the start of treatment; * 6\. Adequate bone marrow and organ function as confirmed during the screening period; * 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; * 9\. Participants with locally advanced, unresectable, or metastatic solid tumors who have failed or are intolerant to standard therapy. Exclusion Criteria: * 1\. Participation in any interventional clinical study other than observational (non-interventional) studies, or currently in the up period of an interventional study; * 2\. Adverse reactions from prior anti-tumor therapies that have not resolved to Grade 0 or 1, or baseline levels, according to NCI CTCAE v6.0, prior to the first dose of study drug (exceptions include alopecia, fatigue, hyperpigmentation, or other conditions deemed without safety risk by the investigator); * 3\. 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. * 4\. Patients with imaging results during the screening period suggesting that the tumor surrounds important blood vessels, or there is obvious necrosis or cavity, and the investigator judges that there is a risk of bleeding; * 5\. Tumor invasion into surrounding critical organs or structures (e.g., cardiac pericardium, mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal/respiratory fistula formation; * 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 hypersensitivity, allergic reaction, or intolerance to IBI3043 or its excipients.

Primary outcome measure(s)

  • Adverse Event (part 1) — up to 2 years
  • ORR (part 2) — up to 2 years
  • Serious Adverse Event — up to 2 years
  • Maximum Tolerated Dose (part 1) — up to 2 years
  • DLT(Dose-limiting Toxicity) (part 1) — up to 2 years

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangzhou
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07902804 on ClinicalTrials.gov ↗ ← All trials in China