A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
A Phase I Study to Assess the Safety, Tolerability and Biomarker Profiles of CBA-1535, Recombinant Protein Tribody in Patients With Previously Treated Advanced Solid Tumors.
Chiome Bioscience Inc.
70 participants
Jun 27, 2022
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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
Exclusion Criteria3
- 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
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Interventions
Dosing is increased from 0.1 µg/body until DLT or disease progression occurs.
Drug：CBA-1535 First Dosing will be determined by Part 1. And dosing will be increased until DLT or disease progression occurs. Drug：Pembrolizumab 200 mg/body
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07016997