Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-30 @ 9:23 PM
Study NCT ID:
NCT06783569
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors
Sponsor:
JiaRay Group
Organization:
Study Overview
Official Title:
A First-in-Human, Open-Label, Dose Escalation and Expansion Study of JR8603 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:
The goal of this clinical trial is to learn if the investigational drug (JR8603) is safe and effective in treating patients with solid tumors after their initial rounds of treatment with other drugs did not work.
Detailed Description:
This is a 2-part, first-in-human, open-label study to determine the safety and tolerability and preliminary efficacy of JR8603 in patients with locally advanced or metastatic solid tumors who have progressed after or are intolerant to standard therapies. The study will include a Dose Escalation Part and a Dose Expansion Part. JR8603 will be administered as a short IV infusion on Days 1, 8, and 15 of continuous 28-day cycles. Safety and tolerability of JR8603 will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. All patients will be assessed for response using Response Criteria for Evaluation in Solid Tumors (RECIST) v1.1, with computed tomography (CT) or magnetic resonance imaging (MRI) occurring at screening within 28 days of first dose, then every 8 weeks (±7 days) after Cycle 1 Day 1 (C1D1) for the first year and every 12 weeks (±7 days) thereafter. Serial blood samples for determination of PK will be collected.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: