NCT07545356 A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
| NCT ID | NCT07545356 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kivu Bioscience Inc. |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2026-05-25 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 76 participants in total. It began in 2026-05-25 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Sandra Calman, MD
STUDY CHAIR
Kivu Bioscience
Frequently Asked Questions
Who can join the NCT07545356 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07545356 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07545356 currently recruiting?
Yes, NCT07545356 is actively recruiting participants. Contact the research team at KIVU30501@kivubioscience.com for enrollment information.
Where is the NCT07545356 trial being conducted?
This trial is being conducted at Sydney, Australia, Wollongong, Australia, Brisbane, Australia.
Who is sponsoring the NCT07545356 clinical trial?
NCT07545356 is sponsored by Kivu Bioscience Inc.. The principal investigator is Sandra Calman, MD at Kivu Bioscience. The trial plans to enroll 76 participants.