Overview
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.
Description
To evaluate safety and efficacy of CBA-1535 in the following two parts in a stepwise manner:
Part 1
- In Part 1, the primary objective is to evaluate the safety and tolerability of CBA-1535 in patients with solid tumors where no standard treatment is available, or who are intolerant to or non-responders to standard treatments.
Additionally, the PK, biomarker profiles, and preliminary efficacy will be evaluated. The initial dose for Part 2 will also be determined.
Part 2
- In Part 2, The primary objective is to evaluate the safety and tolerability of CBA-1535 in combination with pembrolizumab in patients with solid tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment. Additionally, the PK, biomarker profiles, preliminary efficacy will be evaluated. The recommended Phase 2 dose (R2PD) will also be determined.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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