KIVU-305 for Advanced or Spreading Solid Tumors
Tests the safety of KIVU-305 in adults with advanced solid tumors.
Key facts
- Who runs it
- Kivu Bioscience Inc.
- Where
- Brisbane, Sydney, and Wollongong, AustraliaSee the 3 sites
- Trial code
- Registry title
- A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 76 people, planned
- Started
- 25 May 2026
- Expected to end
- Dec 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- KIVU-305
- Record updated
- 22 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic solid tumors that no longer respond to standard treatment or have no standard treatment. It tests a new drug, KIVU-305.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced or metastatic solid tumor, confirmed by pathology or histology, resistant to standard therapy or with no standard therapy available. Measurable disease using RECIST v1.1.
- Earlier treatment
- Cannot have had any ADC with a topoisomerase 1 inhibitor payload, or any CEACAM5 targeted therapy.
Main reasons for not taking part
- Prior ADC with a topoisomerase 1 inhibitor payload
- Prior CEACAM5 targeted therapy
- Uncontrolled cardiovascular disease
- Uncontrolled active Hepatitis B, Hepatitis C, or HIV infection
- History of interstitial lung disease
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in Australia
- Brisbane, QueenslandHospital not named in the registryContact: Kivu Bioscience (US) USTaking people
- Sydney, New South WalesHospital not named in the registryContact: Kivu Bioscience (US) USTaking people
- Wollongong, New South WalesHospital not named in the registryContact: Kivu Bioscience (US) USTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Dose FindingTreatment being tested
Participants will be treated with KIVU-305 in multiple ascending cohorts
Treatment: KIVU-305
- Dose ExpansionTreatment being tested
Participants will be treated with the Recommended Dose for Expansion from Dose Finding.
Treatment: KIVU-305
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1 Dose-Finding and Dose Optimization-Expansion Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
- Plain-language title
- KIVU-305 for Advanced or Spreading Solid TumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 22 September 2026