Ignite Creation Date:
2024-05-06 @ 1:43 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04105335
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-05
First Post:
2019-08-16
Brief Title:
A Study of MTL-CEBPA in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumours TIMEPOINT
Sponsor:
Mina Alpha Limited
Organization:
Mina Alpha Limited
Study Overview
Official Title:
An Open Label Phase 1ab Study of MTL-CEBPA in Combination With a PD-1 Inhibitor Pembrolizumab in Adult Patients With Advanced Solid Tumours
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
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:
TIMEPOINT
Brief Summary:
This is an open label Phase 1a1b study in patients who have advanced solid cancer tumours Patients will receive MTL-CEBPA an experimental drug in combination with pembrolizumab a drug which has been given approval for use for some tumour types
The Phase 1a dose escalation part of the study is designed to establish which doses of MTL-CEBPA are safe and well-tolerated when combined with the standard dose of pembrolizumab Patients recruited to this part of the study will be those whose cancer progressed on standard treatments or for whom no treatments are available
Phase 1b the dose expansion part of the study will further explore how safe and well-tolerated these two drugs are when combined and will assess if the combination of drugs could potentially reduce the size of tumours Participants in this part of the study will receive the experimental drug MTL-CEBPA at a dose which is considered safe and well-tolerated based on data from the first part of the study Phase 1a Participants will remain in the study taking study drugs until either death or they choose to withdraw from the study
The Phase 1a dose escalation part of the study is designed to establish which doses of MTL-CEBPA are safe and well-tolerated when combined with the standard dose of pembrolizumab Patients recruited to this part of the study will be those whose cancer progressed on standard treatments or for whom no treatments are available
Phase 1b the dose expansion part of the study will further explore how safe and well-tolerated these two drugs are when combined and will assess if the combination of drugs could potentially reduce the size of tumours Participants in this part of the study will receive the experimental drug MTL-CEBPA at a dose which is considered safe and well-tolerated based on data from the first part of the study Phase 1a Participants will remain in the study taking study drugs until either death or they choose to withdraw from the study
Detailed Description:
Phase 1a comprises three planned dose cohorts ascending dose 33 design at the following dose levels 70 mgm2 QW 98 mgm2 QW and 130 mgm2 QW of MTL-CEBPA combined with standard dose of pembrolizumab given every 3 weeks The aim is to assess the safety and tolerability of MTL-CEBPA in combination with pembrolizumab recruiting patients whose disease progressed on standard of care therapy or for whom no therapy is available
In the first dose cohort the first participant enrolled will receive MTL-CEBPA treatment at the 70mgm2 QW dose level Pembrolizumab 200mg will be administered on Day 2 of the first cycle and subsequently every 3 weeks whilst participant is on treatment MTL-CEBPA and pembrolizumab will not be administered on the same day
Phase 1b of the study will further evaluate safety tolerability and assess the clinical activity of MTL-CEBPA and a PD-1 inhibitor pembrolizumab in combination
Participants will receive MTL-CEBPA at a dose considered most appropriate with regards to safety tolerability and efficacy for further development based on data from Phase 1a of the study
Patients with the following but not limited to solid tumours will be specifically targeted breast lung ovarian pancreatic gall bladder HCC neuroendocrine and cholangiocarcinoma
In the first dose cohort the first participant enrolled will receive MTL-CEBPA treatment at the 70mgm2 QW dose level Pembrolizumab 200mg will be administered on Day 2 of the first cycle and subsequently every 3 weeks whilst participant is on treatment MTL-CEBPA and pembrolizumab will not be administered on the same day
Phase 1b of the study will further evaluate safety tolerability and assess the clinical activity of MTL-CEBPA and a PD-1 inhibitor pembrolizumab in combination
Participants will receive MTL-CEBPA at a dose considered most appropriate with regards to safety tolerability and efficacy for further development based on data from Phase 1a of the study
Patients with the following but not limited to solid tumours will be specifically targeted breast lung ovarian pancreatic gall bladder HCC neuroendocrine and cholangiocarcinoma
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-002231-28 | EUDRACT_NUMBER | None | None |