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A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors

NCT07545356 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

KIVU-305

KIVU-305 will be administered IV .

Sponsors & Collaborators

  • Kivu Bioscience Inc.

    lead INDUSTRY

Principal Investigators

  • Louie Naumovski, MD, PhD · Kivu Bioscience

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07545356 on ClinicalTrials.gov