Ignite Creation Date:
2024-05-06 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03389802
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2017-12-15
Brief Title:
Phase I Study of APX005M in Pediatric Central Nervous System Tumors
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects With RecurrentRefractory Brain Tumors and Newly Diagnosed Brain Stem Glioma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing spreading or getting worse progressive or newly diagnosed diffuse intrinsic pontine glioma APX005M can trigger activation of B cells monocytes and dendritic cells and stimulate cytokine release from lymphocytes and monocytes APX005M can mediate a direct cytotoxic effect on CD40 tumor cells
Detailed Description:
This is a multicenter phase I trial of APX005M in patients with recurrent or refractory primary malignant central nervous system tumor or newly diagnosed diffuse intrinsic pontine glioma
APX005M is a humanized IgG1κ mAb that binds to CD40 APX005M binds to both human and cynomolgus monkey CD40 with high affinity triggering activation of B cells monocytes and dendritic cells and stimulating cytokine release from both human and monkey lymphocytes and monocytes APX005M does not bind to mouse or rat CD40 CD40 is also expressed on many human tumor cells and APX005M can mediate a direct cytotoxic effect on CD40 tumor cells
Activation of CD40 on tumor cells results in tumor cell apoptosis and inhibition of tumor growth CD40 agonistic antibodies have demonstrated potent antitumor immune response stimulation in both animal models and cancer patients Due to its action on both immune and tumor cells CD40 has been studied as a target for novel cancer immunotherapy
Apexigen has declared the adult recommended phase 2 dose to be 03 mgkg because no dose limiting toxicities were encountered at that dose and the pharmacodynamic profile was similar to the 1 mgkg maximally tolerated dose This phase 1 clinical trial is to study APX005M in children with central nervous system tumors
APX005M is a humanized IgG1κ mAb that binds to CD40 APX005M binds to both human and cynomolgus monkey CD40 with high affinity triggering activation of B cells monocytes and dendritic cells and stimulating cytokine release from both human and monkey lymphocytes and monocytes APX005M does not bind to mouse or rat CD40 CD40 is also expressed on many human tumor cells and APX005M can mediate a direct cytotoxic effect on CD40 tumor cells
Activation of CD40 on tumor cells results in tumor cell apoptosis and inhibition of tumor growth CD40 agonistic antibodies have demonstrated potent antitumor immune response stimulation in both animal models and cancer patients Due to its action on both immune and tumor cells CD40 has been studied as a target for novel cancer immunotherapy
Apexigen has declared the adult recommended phase 2 dose to be 03 mgkg because no dose limiting toxicities were encountered at that dose and the pharmacodynamic profile was similar to the 1 mgkg maximally tolerated dose This phase 1 clinical trial is to study APX005M in children with central nervous system tumors
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1CA081457 | NIH | None | None |
| PBTC-051 | OTHER | None | None |
| PBTC-051 | OTHER | None | None |
| NCI-2017-01235 | REGISTRY | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchUM1CA081457 |