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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07545356




Registration number
Help: Registration number
NCT07545356
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
16/04/2026
Date registered
Help: Date registered
22/04/2026
Date last updated
Help: Date last updated
22/09/2026

Titles & IDs
Public title
A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1 Dose-Finding and Dose Optimization-Expansion Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
Additional trial identifiers [1] 0 0
KIVU-305-01
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - KIVU-305

Experimental: Dose Finding - Participants will be treated with KIVU-305 in multiple ascending cohorts

Experimental: Dose Expansion - Participants will be treated with the Recommended Dose for Expansion from Dose Finding.


Treatment: Drugs: KIVU-305
KIVU-305 will be administered IV .
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
To determine Maximum tolerated dose (MTD)
Timepoint [1] 0 0
up to 18 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Kivu Trial Site - Sydney
Recruitment hospital [2] 0 0
Kivu Trial Site - Wollongong
Recruitment hospital [3] 0 0
Kivu Trial Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Wollongong
Recruitment postcode(s) [3] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kivu Bioscience Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sandra Calman, MD
Address 0 0
Kivu Bioscience
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kivu Bioscience (US) US
Address 0 0
Country 0 0
Phone 0 0
+1 650.606.5170
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07545356