A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorChiome Bioscience Inc.
About this trial
This is a First in Human muticenter, non-randomized, open-label Phase I dose-escalation study of CBA-1535.
The study will have 2 parts (Part 1 and Part 2). Part 1 is the dose-escalation cohorts of CBA-1535 single agent theapy. Part 2 is the dose-escalation cohorts of CBA-1535 in combination with Pembrlizumab.
This study will evaluate the safety, tolerability, PK, biomarker profiles and preliminary efficacy of CBA-1535.
Eligibility criteria
Qualifiers
Patients who provide voluntary written informed consent to participate in the study
ECOG performance status: <= 1
Patients with 3 months or longer life expectancy
Patients with solid tumors for whom no standard therapy is available or who are refractory to or intolerant of standard therapy
Disqualifiers
Patients who received other investigational drug or antibody drugs, including immune checkpoint inhibitor within 28 days prior to enrollment
Patients who received anti-cancer drug within 14 days prior to enrollment
Patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies (Chinese hamster ovary cell-derived drugs) or any component of the study drug
Trial design
Treatments tested in this trial
- CBA-1535
- CBA-1535+Pembrolizumab
Treatment groups
70 Participants
are divided into 2 treatment groupsLocations
2Map coordinates are unavailable for these locations. Locations are shown below instead.
Shizuoka Cancer CenterRecruiting Nagaizumicho, Shizuoka
Japan
JapanNational Cancer Center HospitalRecruiting Chuo-Ku, TokyoJapan
JapanSponsors and collaborators
Source ClinicalTrials.gov