Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652529
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Phase 1 Dose Escalation and Expansion to Evaluate AROG4-01 in Patients with Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
First in Human Phase 1 Dose Escalation and Expansion Clinical Trial to Evaluate the Safety Pharmacokinetics and Antitumor Activity of Intravenous AROG4-01 in Patients with Advanced Solid Tumors
Status:
NOT_YET_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:
CLINBERMES
Brief Summary:
The goal of this clinical trial is to learn if drug AROG4-01 is safe in patients with solid tumors who have no available treatment alternative Different doses will be tested in order to identify the most suitable one Once it is identiffied up to 20 patients will be treated with that dose to check if thye get clinical benefit
Participants will receive intravenous administrations of ARG4-01 twice weekly and visit the clinic twice every week for checkups and tests
Participants will receive intravenous administrations of ARG4-01 twice weekly and visit the clinic twice every week for checkups and tests
Detailed Description:
This study is an open label Phase 1 dose escalation trial with two expansion cohorts to investigate the safety tolerability pharmacokinetics pharmacodynamics and preliminary antitumor activity of AROG4-01 in patients with mesothelioma and other advanced solid tumors
This clinical trial is divided into two parts dose escalation part A and dose expansion part B
Dose escalation In the present trial patients will be enrolled sequentially into escalating dose cohorts and will continue receiving AROG4-01 until disease progression unacceptable toxicity withdrawal of consent or otherwise as specified in the investigational medicinal product IMP discontinuation criteria
Patients in a dose cohort will receive AROG4-01 as intravenous IV administrations at the same dose in a dosing interval of twice a week four weeks equal to one cycle consecutively without interruption except when necessary to manage adverse events AEs
Six cohorts at escalating dose levels are envisaged Dose escalation may continue beyond until the recommended for part B dose which will be the recommended for phase 2 dose RP2D can be defined based on safety preliminary efficacy PK and PD data based on the recommendations of the Safety Review Committee SRC The RP2D is defined as the recommended for phase 2 dose but two cohorts will be treated as part of the phase 1 expansion with that particular dose in order to get more safety and efficacy data
Escalation to the next dose level will occur following the SRC meeting for the most recently completed cohort In considering the appropriate dose level for the next cohort the following will be applied
The maximum dose increment will be limited to 100 if patients of a given cohort experience one Grade 2 AE during the DLT period or if at least one patient decreases 10 weight
The maximum dose increment will be limited to 50 if a patient of a given cohort experiences one DLT during the DLT period
If the prior circumstances do not occur dose escalation will continue at higher increments not exceeding three times prior dose level as determined by the SRC
Extension phase At the dose expansion part two cohorts of patients with advanced solid tumor each will be recruited One cohort of patients with advanced MPM cohort 1 and a second cohort of patients with other solid tumors cohort 2 Patients will be treated with AROG4-01 at the RP2D of AROG4-01 resulting from part A
This clinical trial is divided into two parts dose escalation part A and dose expansion part B
Dose escalation In the present trial patients will be enrolled sequentially into escalating dose cohorts and will continue receiving AROG4-01 until disease progression unacceptable toxicity withdrawal of consent or otherwise as specified in the investigational medicinal product IMP discontinuation criteria
Patients in a dose cohort will receive AROG4-01 as intravenous IV administrations at the same dose in a dosing interval of twice a week four weeks equal to one cycle consecutively without interruption except when necessary to manage adverse events AEs
Six cohorts at escalating dose levels are envisaged Dose escalation may continue beyond until the recommended for part B dose which will be the recommended for phase 2 dose RP2D can be defined based on safety preliminary efficacy PK and PD data based on the recommendations of the Safety Review Committee SRC The RP2D is defined as the recommended for phase 2 dose but two cohorts will be treated as part of the phase 1 expansion with that particular dose in order to get more safety and efficacy data
Escalation to the next dose level will occur following the SRC meeting for the most recently completed cohort In considering the appropriate dose level for the next cohort the following will be applied
The maximum dose increment will be limited to 100 if patients of a given cohort experience one Grade 2 AE during the DLT period or if at least one patient decreases 10 weight
The maximum dose increment will be limited to 50 if a patient of a given cohort experiences one DLT during the DLT period
If the prior circumstances do not occur dose escalation will continue at higher increments not exceeding three times prior dose level as determined by the SRC
Extension phase At the dose expansion part two cohorts of patients with advanced solid tumor each will be recruited One cohort of patients with advanced MPM cohort 1 and a second cohort of patients with other solid tumors cohort 2 Patients will be treated with AROG4-01 at the RP2D of AROG4-01 resulting from part A
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None