KIVU-305 for advanced solid tumors
Official title: A Phase 1 Dose-Finding and Dose Optimization-Expansion Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
Run by Kivu Bioscience Inc. · NCT07545356 · Data updated 2026-11-12
This first-in-human study tests KIVU-305, a CEACAM5-targeted antibody-drug conjugate, in adults with locally advanced or metastatic solid tumors that have no good standard options left or are resistant to current therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Kivu Bioscience Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Sydney, New South Wales and 2 other locations) |
| Status | Recruiting |
| Started | May 25, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2029 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT07545356 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with advanced/metastatic solid tumors resistant to standard therapy or without good options, measurable disease, and adequate organ function.
✕Probably not a fit
Patients with rapid disease progression, severe comorbidities, or intolerance to this class of therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-part, open-label phase 1 study to determine safety, tolerability and preliminary signals of activity for KIVU-305 in adults with advanced solid tumors. Participants must have measurable disease, adequate organ function, and good performance status (ECOG 0-1). Exclusions include prior ADCs with topoisomerase I payload or CEACAM5 therapies, and uncontrolled infections or cardiovascular/ILD conditions. The study will enroll patients at sites in Sydney, Wollongong, and Brisbane, Australia.
Why it matters
Potential benefit: If successful, participants may experience disease stabilization or tumor shrinkage and gain access to a potentially new therapy.
How similar studies have gone: Historically, antibody-drug conjugates targeting CEACAM5 have shown limited but encouraging signals in some solid tumors; this approach is exploratory in first-in-human testing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female ≥18 years of age * Pathologically or histologically documented diagnosis of advanced / metastatic solid tumor malignancy that is resistant to standard therapy or for which no standard therapy is available * Adequate bone marrow, kidney, and liver function * Measurable disease using RECIST v1.1 * ECOG 0 or 1 * Life expectancy ≥ 3 months Exclusion Criteria: * Prior treatment with any ADC with a topoisomerase 1 inhibitor payload * Prior treatment with any CEACAM5 targeted therapy * Uncontrolled cardiovascular disease * Uncontrolled active Hepatitis B, Hepatitis C, or HIV infection * History of interstitial lung disease * Major surgery, radiation therapy, or systemic anti-cancer within 3 weeks of study treatment start
Where it's running
-
Kivu Trial Site
Sydney, New South Wales, Australia Recruiting -
Kivu Trial Site
Wollongong, New South Wales, Australia Recruiting -
Kivu Trial Site
Brisbane, Queensland, Australia Recruiting
Study contacts
- Study coordinator: Kivu Bioscience (US) US
- Email: KIVU30501@kivubioscience.com
- Phone: +1 650.606.5170
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.