Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-02 @ 12:18 PM
Study NCT ID:
NCT06636435
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2024-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer
Sponsor:
Chiome Bioscience Inc.
Organization:
Study Overview
Official Title:
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.
Detailed Description:
To evaluate safety and efficacy of CBA-1205 in the following five parts in a stepwise manner:
Part 1
* In Part 1, safety and tolerability in patients with Solid Tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. Initial dose for Part 2 will be determined.
Part 2
* In Part 2, safety and tolerability in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. Recommended dose in this population will be determined.
Part 3
* In Part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated.
Part 4
* In Part 4, safety and efficacy in patients with Malignant Melanoma who are refractory or intolerant to standard therapy.
Part 5
* In Part 5, safety, tolerability and the recommended dose of the study drug in patients with Pediatric Cancer where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated.
PK analysis
Part 1
* In Part 1, safety and tolerability in patients with Solid Tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. Initial dose for Part 2 will be determined.
Part 2
* In Part 2, safety and tolerability in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. Recommended dose in this population will be determined.
Part 3
* In Part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated.
Part 4
* In Part 4, safety and efficacy in patients with Malignant Melanoma who are refractory or intolerant to standard therapy.
Part 5
* In Part 5, safety, tolerability and the recommended dose of the study drug in patients with Pediatric Cancer where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated.
PK analysis
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| jRCT2080225288 | OTHER | Japan Registry of Clinical Trials | View |