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Clinical Trials in Australia / NCT07545356
Recruiting Phase 1

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

NCT07545356 · tracked via the Priya Life Science Australia tracker
Sponsor
Kivu Bioscience Inc
Phase
Phase 1
Started
2026-05-25
Last updated
2026-09-22

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

KIVU-305

KIVU-305: KIVU-305 will be administered IV .

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • To determine Maximum tolerated dose (MTD) — up to 18 months
    Number of participants with treatment emergent adverse events as assessed by CTCAE Version 6.0.

Trial sites (3)

FacilityCityRegionStatus
Kivu Trial Site Sydney New South Wales Recruiting
Kivu Trial Site Wollongong New South Wales Recruiting
Kivu Trial Site Brisbane Queensland Recruiting

More Kivu Bioscience Inc. trials in Australia

A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors Recruiting

Other trials for the same condition

Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors Active, not recruiting
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Active, not recruiting
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma Recruiting
A Study of PEP08 in Patients With MTAP-Del Advanced or Metastatic Solid Tumors Recruiting
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07545356 on ClinicalTrials.gov ↗ ← All trials in Australia