Phase 1 KIVU-305 CEACAM5 ADC Trial for Solid Tumors
Summary
NIH has registered a Phase 1 first-in-human, open-label study (NCT07545356) evaluating KIVU-305, a CEACAM5-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors. The 2-part study will assess safety, tolerability, and preliminary efficacy. This is a clinical trial registration entry documenting study design, conditions, and interventions as listed on ClinicalTrials.gov.
“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.”
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What changed
NIH has registered a Phase 1 clinical trial (NCT07545356) for KIVU-305, a CEACAM5-directed antibody-drug conjugate being evaluated in participants with locally advanced or metastatic solid tumors. The first-in-human, open-label study is designed in 2 parts to determine safety, tolerability, and preliminary efficacy.
Healthcare providers and clinical investigators in oncology settings may encounter this trial for patient referral or enrollment considerations. Trial sponsors and pharmaceutical companies developing similar ADC (antibody-drug conjugate) therapeutics targeting CEACAM5 may monitor this study for preliminary safety and efficacy signals in solid tumor indications.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
Phase 1 NCT07545356 Kind: PHASE1 Apr 22, 2026
Abstract
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.
Conditions: Solid Tumors
Interventions: KIVU-305
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