A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKivu Bioscience Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
KIVU-305
DrugKIVU-305 will be administered IV .
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Dose FindingExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To determine Maximum tolerated dose (MTD)
Number of participants with treatment emergent adverse events as assessed by CTCAE Version 6.0.
Time frame
up to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov