NCT07545356
Not yet recruiting
Phase 1
A Phase 1 Dose-Finding and Dose Optimization-Expansion Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
Kivu Bioscience Inc.1 site in 1 country76 target enrollmentStarted: June 1, 2026Last updated:
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Kivu Bioscience Inc.
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- To determine Maximum tolerated dose (MTD)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Dose Finding
Experimental
Participants will be treated with KIVU-305 in multiple ascending cohorts
Intervention: KIVU-305 (Drug)
Dose Expansion
Experimental
Participants will be treated with the Recommended Dose for Expansion from Dose Finding.
Intervention: KIVU-305 (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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