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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031210708 | Other Grant/Funding Number | Japan Registry of Clinical Trials |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: CBA-1535 (single agent therapy) | Experimental | Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 of each 21-day cycle. |
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| Part 2: CBA-1535+Pembrolizumab | Experimental | Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 , and Pembrolizumab as Q3W IV infusion at fix dose on Day 1 of each 21-day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBA-1535 | Drug | Dosing is increased from 0.1 µg/body until DLT or disease progression occurs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity | DLTs are assessed according to CTCAE v.5.0 during the first cycle (21 days). | Up to 21 days in Cycle 1 |
| Adverse event | 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. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum CBA-1535 concentration | Blood samples are collected to assess the serum concentration of CBA-1535. | From Day 1 to Day 22 |
| Efficacy in previously treated advanced solid Tumors. | Efficacy evaluation based on RECIST v.1.1 is performed by CT or MRI scan or others. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiome Bioscience Inc. | Contact | +81-3-6383-3561 | ir@chiome.co.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shizuoka Cancer Center | Recruiting | Nagaizumicho | Shizuoka | Japan | ||
| National Cancer Center Hospital |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| CBA-1535+Pembrolizumab | Drug | 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 |
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| Up to approximately 24 months. |
| Recruiting |
| Chuo-Ku |
| Tokyo |
| Japan |