Refractory Cancer, Solid Tumors
Conditions
Keywords
CBA-1535, 5T4, CD3, T cell Engager, Trophoblast Glycoprotein, Tribody, solid tumors
Brief 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.
Detailed 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.
Interventions
DRUGCBA-1535
Dosing is increased from 0.1 µg/body until DLT or disease progression occurs.
DRUGCBA-1535+Pembrolizumab
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
Sponsors
Chiome Bioscience Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity | Up to 21 days in Cycle 1 | DLTs are assessed according to CTCAE v.5.0 during the first cycle (21 days). |
| Adverse event | Up to approximately 24 months | An adverse event is any untoward or unintended sign, symptom, or disease in a subject administered an investigational product, regardless of whether or not it is related to the investigational product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum CBA-1535 concentration | From Day 1 to Day 22 | Blood samples are collected to assess the serum concentration of CBA-1535. |
| Efficacy in previously treated advanced solid Tumors. | Up to approximately 24 months. | Efficacy evaluation based on RECIST v.1.1 is performed by CT or MRI scan or others. |
Countries
Japan
Contacts
Primary ContactChiome Bioscience Inc.
Outcome results
None listed