A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KIVU-305.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Dose-Finding and Dose Optimization-Expansion Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
Overview
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.
Interventions
- Drug KIVU-305
KIVU-305 will be administered IV .
Primary outcome measures
- To determine Maximum tolerated dose (MTD) [Time frame: up to 18 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- Kivu Trial Site — Sydney
- Kivu Trial Site — Wollongong
- Kivu Trial Site — Brisbane
Identifiers
NCT: NCT07545356 · KIVU-305-01