A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
About this study
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.
- Condition
- Solid Tumors
- Tested
- KIVU-305
- Sponsor
- Kivu Bioscience Inc.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Solid Tumors
- 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 6
- 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
3 sites, 3 recruiting
Kivu Trial Site
Brisbane, Queensland, Australia
Kivu Trial Site
Sydney, New South Wales, Australia
Kivu Trial Site
Wollongong, New South Wales, Australia
Contact
-
Kivu Bioscience (US) US
+1 650.606.5170 KIVU30501@kivubioscience.com
-
Kivu Bioscience (AUS) AUS
+6 187.223.0122 KIVU30501@kivubioscience.com
Potential match only. Final eligibility is determined by the study team.