Ignite Creation Date:
2024-05-06 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03490669
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2018-02-07
Brief Title:
Study to Evaluate Safety PK PD Immunogenicity Antitumor Activity of MSC-1 in Patients With Adv Solid Tumors
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase 1 Multicenter Open-Label Dose-Escalation and Dose-Expansion Study to Evaluate the Safety Pharmacokinetics Pharmacodynamics Immunogenicity and Antitumor Activity of MSC-1 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-04
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:
This is a 2-part study to evaluate the safety and antitumor activity of MSC-1 MSC-1 is a first-in-class humanized monoclonal antibody IgG1 which binds to the immunosuppressive human cytokine Leukemia Inhibitory Factor LIF and is intended to treat adult patients with Advanced Solid Tumors
In part 1 multiple dose levels of MSC-1 in patients with advanced solid tumors will be studied to determine the recommended dose for further evaluation of safety and efficacy in Part 2
In part 1 multiple dose levels of MSC-1 in patients with advanced solid tumors will be studied to determine the recommended dose for further evaluation of safety and efficacy in Part 2
Detailed Description:
MSC-1 is a first-in-class humanized monoclonal antibody IgG1 which binds to the immunosuppressive human cytokine Leukemia Inhibitory Factor LIF and is intended to treat adult patients with advanced solid tumors LIF is a pleiotropic cytokine involved in many physiological and pathological processes including the promotion of an immunosuppressive environment In cancer it is hypothesized that LIF expressing malignancies co-opt this activity creating an immunosuppressive tumor microenvironment as well as promoting the activity of cancer-initiating cells CICs LIF is highly expressed in a subset of tumors across multiple solid tumor types
During dose escalation patients with advanced solid tumors will be treated with MSC-1 with the primary objective of determining the safety and tolerability of MSC-1 and defining an appropriate dose for further evaluation in dose expansion MSC-1 will be administered intravenously IV until disease progression unmanageable toxicity withdrawal of consent or study termination
In dose expansion up to 4 parallel cohorts of patients with LIF-High tumors NSCLC Ovarian Cancer Pancreatic Cancer and a cohort of mixed solid tumors referred to as the basket cohort may be treated at the recommended expansion dose to further characterize the safety tolerability PK PD and anti-tumor activity of MSC-1
During dose escalation patients with advanced solid tumors will be treated with MSC-1 with the primary objective of determining the safety and tolerability of MSC-1 and defining an appropriate dose for further evaluation in dose expansion MSC-1 will be administered intravenously IV until disease progression unmanageable toxicity withdrawal of consent or study termination
In dose expansion up to 4 parallel cohorts of patients with LIF-High tumors NSCLC Ovarian Cancer Pancreatic Cancer and a cohort of mixed solid tumors referred to as the basket cohort may be treated at the recommended expansion dose to further characterize the safety tolerability PK PD and anti-tumor activity of MSC-1
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 |
|---|---|---|---|
| 2017-003320-79 | EUDRACT_NUMBER | None | None |