Solid Tumors
Conditions
Keywords
CEACAM5, ADC, Antibody drug conjugate, KIVU305, Colorectal cancer, CRC, Phase 1
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.
Interventions
DRUGKIVU-305
KIVU-305 will be administered IV .
Sponsors
Kivu Bioscience Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia
Contacts
CONTACTKivu Bioscience (US) US
CONTACTKivu Bioscience (AUS) AUS
STUDY_CHAIRLouie Naumovski, MD, PhD
Kivu Bioscience
Outcome results
None listed