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
1 other identifier
interventional
76
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2026
CompletedFirst Posted
Study publicly available on registry
April 22, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
Study Completion
Last participant's last visit for all outcomes
December 1, 2029
April 22, 2026
April 1, 2026
1.5 years
April 16, 2026
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine Maximum tolerated dose (MTD)
Number of participants with treatment emergent adverse events as assessed by CTCAE Version 6.0.
up to 18 months
Study Arms (2)
Dose Finding
EXPERIMENTALParticipants will be treated with KIVU-305 in multiple ascending cohorts
Dose Expansion
EXPERIMENTALParticipants will be treated with the Recommended Dose for Expansion from Dose Finding.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kivu Trial Site
Sydney, Australia, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Louie Naumovski, MD, PhD
Kivu Bioscience
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2026
First Posted
April 22, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2029
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product, the study sponsor and/or its affiliated companies may share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research.