NCT07545356RecruitingPhase 1
A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 Dose-Finding and Dose Optimization-Expansion Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
This is a 2-part, first-in-human, open-label study to determine the safety, tolerability and preliminary efficacy of KIVU-305, a CEACAM5-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 16 Apr 2026
- Start date
- 25 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Kivu Bioscience Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT07545356
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 76
- From 25 May 2026 to the primary completion date, 31 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any ADC with a topoisomerase 1 inhibitor payload
- Prior treatment with any CEACAM5 targeted therapy
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kivu Trial Site Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Kivu Trial Site Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Kivu Trial Site Coordinator of this site? Confirm its status | Wollongong | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.