A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
ConditionAdvanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKyowa Kirin Co., Ltd.
About this trial
This is the first in human study of KK2260. In Part 1a, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2260 in patients with advanced or metastatic solid tumors (any cancer type). In Part 1b and Part 2, at least two dosing regimens and two dosing regimens by cancer type, respectively, will be selected, and the safety, tolerability, and efficacy of each regimen will be evaluated.
Eligibility criteria
Qualifiers
Patients who have given informed written consent.
Male or female subjects ≥18 years of age, at time of signing informed consent.
Subjects who are refractory to standard treatment, intolerant of standard treatment, for whom standard treatment does not exist, or who have refused standard treatment.
Patients with measurable disease according to RECIST version 1.1
Disqualifiers
Patients with central or brain pia mater metastases that are untreated and symptomatic or that require treatment.
Patients with concurrent multiple or synchronous cancers, or with iatrogenic multiple or synchronous cancers with a disease-free interval of 5 years or less.
Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs.
Patients who have had a Grade 3 or higher allergic reaction to an antibody agent or an additive of the study drug.
Trial design
Treatments tested in this trial
- KK2260
- KK2260
Treatment groups
189 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov