Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT05549557
Status:
UNKNOWN
Last Update Posted:
2022-09-22
First Post:
2022-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IMM40H Phase I Dose Escalation and Expansion
Sponsor:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Organization:
Study Overview
Official Title:
An Open-label, Multi-center Phase I Clinical Study of IMM40H in Patients With Advanced Solid Tumor and Hematological Malignancies
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
NOT_YET_RECRUITING
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:
This is first-in-human, open-label, multi-center, dose-escalation (phase Ia) and cohort expansion (phase Ib) phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, immunogenicity, and antitumor activities of IMM40H in patients with advanced malignancies including solid tumor and hematological malignancies.
Detailed Description:
This study will include 16\~27 patients with advanced malignancies that have progressed after or have no response to previous standard treatments or for whom no standard treatments are available (including but not limited to melanoma, nasopharyngeal cancer, thymoma, RCC, colorectal cancer, non-small cell lung cancer (NSCLC), glioblastoma, astrocytoma, ovarian cancer, AML, and lymphoma). The primary objective is to determine the maximum tolerated dosage (MTD) or recommended dose for expansion (RDE) by observing the safety and tolerability of IMM40H monotherapy.
The adjusted "3 + 3" design will be adopted in this trial for dose escalation, with the starting dose of IMM40H at 0.3 mg/kg and the temporary maximum dose at 20 mg/kg. In the dose-escalation stage, a total of 5 dose levels will be designed:0.3, 1, 3, 10, 20 mg/kg, to determine MTD . For each subject in each dose group, the dose will be gradually increased according to the dose-escalation rules, and the observation period for dose-limiting toxicity (DLT) will be set to be 28 days after the first dose.
Patients with CD70-positive malignancies to further evaluate the safety, PK characteristics, immunogenicity, and anti-tumor activity or preliminary efficacy of IMM40H dosing at MTD.
The adjusted "3 + 3" design will be adopted in this trial for dose escalation, with the starting dose of IMM40H at 0.3 mg/kg and the temporary maximum dose at 20 mg/kg. In the dose-escalation stage, a total of 5 dose levels will be designed:0.3, 1, 3, 10, 20 mg/kg, to determine MTD . For each subject in each dose group, the dose will be gradually increased according to the dose-escalation rules, and the observation period for dose-limiting toxicity (DLT) will be set to be 28 days after the first dose.
Patients with CD70-positive malignancies to further evaluate the safety, PK characteristics, immunogenicity, and anti-tumor activity or preliminary efficacy of IMM40H dosing at MTD.
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?:
None
Is an FDA AA801 Violation?: