Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07545356

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Solid Tumors Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kivu Trial Site, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KIVU-305

Drug

KIVU-305 will be administered IV .

Primary outcomes

  1. To determine Maximum tolerated dose (MTD)

    Time frame: up to 18 months

    Number of participants with treatment emergent adverse events as assessed by CTCAE Version 6.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Kivu Bioscience (AUS) AUS

CONTACT

[email protected]

+6 187.223.0122

Kivu Bioscience (US) US

CONTACT

[email protected]

+1 650.606.5170

Sponsors and collaborators

Lead sponsor

Kivu Bioscience Inc.

Industry

Registry information

Official study title

A Phase 1 Dose-Finding and Dose Optimization-Expansion Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Apr 22, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.