A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors (NCT07545356) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
Australia76 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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