Actively Recruiting
A Phase I Study to Assess Safety, Tolerability, and Biomarker Profiles of CBA-1535, a Recombinant Protein Tribody, in Patients With Previously Treated Advanced Solid Tumors
Led by Chiome Bioscience Inc. · Updated on 2025-06-12
70
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CBA-1535, a T cell engager, in patients with advanced solid tumors who have no standard treatment options or who cannot tolerate or do not respond to standard therapies. This is a first-in-human, multicenter, open-label Phase I study that aims to assess the safety, tolerability, pharmacokinetics, biomarker profiles, and preliminary efficacy of CBA-1535 alone and in combination with pembrolizumab. The study has two parts. In Part 1, patients receive escalating doses of CBA-1535 alone as a weekly intravenous infusion on Days 1, 8, and 15 of each 21-day cycle. Part 2 involves dose escalation of CBA-1535 combined with fixed-dose pembrolizumab given intravenously every three weeks on Day 1 of each cycle. Dose escalation continues until dose-limiting toxicity or disease progression occurs. The study also determines recommended doses for further research. Participants will be monitored for dose-limiting toxicities during the first 21 days of treatment and adverse events for up to about 24 months. Blood samples will be collected to measure drug levels and biomarker changes. Researchers will evaluate the safety, tolerability, and preliminary anti-tumor activity. Total participation may last up to two years with regular clinical assessments and laboratory tests throughout the study.
CONDITIONS
Brief Title
A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who provide voluntary written informed consent to participate in the study
- ECOG performance status of 0 or 1
- Patients with a life expectancy of 3 months or longer
- Patients with solid tumors for whom no standard therapy is available or who are refractory to or intolerant of standard therapy
You will not qualify if you...
- Patients who received other investigational drugs or antibody drugs, including immune checkpoint inhibitors, within 28 days prior to enrollment
- Patients who received anti-cancer drugs within 14 days prior to enrollment
- Patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies or any component of the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until dose limiting toxicity or disease progression occurs
Participants receive weekly intravenous infusions of CBA-1535 at escalating doses on Day 1, 8, and 15 of each 21-day cycle. In Part 2, participants also receive pembrolizumab as an intravenous infusion on Day 1 of each 21-day cycle.
Weekly visits on Day 1, 8, and 15 of each 21-day cycle; pembrolizumab infusion every 3 weeks
Trial Site Locations
Total: 2 locations
1
Shizuoka Cancer Center
Nagaizumicho, Shizuoka, Japan
Actively Recruiting
2
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan
Actively Recruiting
Research Team
C
Chiome Bioscience Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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