Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640413
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
A Study to Evaluate the Safety and Preliminary Signs of Efficacy of 177LuLu-OncoFAP-23 Alone or in Combination with L19-IL2 As a Treatment of Metastatic FAP-positive Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety and Preliminary Signs of Efficacy of 177LuLu-OncoFAP-23 Alone or in Combination with L19-IL2 As a Treatment of Metastatic FAP-positive 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:
Theratri
Brief Summary:
The aim of this study is to assess the safety of 177LuLu-OncoFAP-23 alone or in combination with L19-IL2 for the treatment of advancedmetastatic Fibroblast Activation Protein FAP-positive solid tumors and to establish a Recommended Dose RD
Detailed Description:
This study is a prospective phase I open-label multiple ascending multi-center dose escalation study to evaluate the safety and preliminary signs of efficacy of 177LuLu-OncoFAP-23 alone and in combination with the antibody-cytokine conjugate L19-IL2 for the treatment of advancedmetastatic FAP-positive solid tumors
Eligible patients for this trial are male or non-pregnant and non-breastfeeding females aged 18 years or more able to give informed consent
Up to 56 evaluable patients will be enrolled in the trial and the trial is divided into two parts
1 Part I - Dose escalation part 2-36 pts This dose escalation part of the study is designed as a standard 33 escalation scheme Not more than 2 patients per cohort are treated simultaneously during the Dose Limiting Toxicity DLT observation period from Day 1 to Day 28 of the first cycle Patients per cohort will be assigned to different dose levels of the study drug
2 Part II - Dose expansion part 20 pts After completion of the dose escalation part additional 20 patients will be enrolled at the RD to better understand the safety profile and to explore early signs of efficacy in different disease indications Patients will be randomly assigned to arm 1 monotherapy or arm 2 combination therapy 10 patients each
Both in part I and II patients can receive up to 4 consecutive cycles of radioligand therapy every 8 1 weeks
The primary objective of this study is to assess the safety of 177LuLu-OncoFAP-23 alone or in combination with L19-IL2 for the treatment of advancedmetastatic FAP-positive malignancies and to establish a Recommended Dose RD
Secondary objectives include evaluation of pharmacokinetics and the collection of initial signs of efficacy of the treatment
Eligible patients for this trial are male or non-pregnant and non-breastfeeding females aged 18 years or more able to give informed consent
Up to 56 evaluable patients will be enrolled in the trial and the trial is divided into two parts
1 Part I - Dose escalation part 2-36 pts This dose escalation part of the study is designed as a standard 33 escalation scheme Not more than 2 patients per cohort are treated simultaneously during the Dose Limiting Toxicity DLT observation period from Day 1 to Day 28 of the first cycle Patients per cohort will be assigned to different dose levels of the study drug
2 Part II - Dose expansion part 20 pts After completion of the dose escalation part additional 20 patients will be enrolled at the RD to better understand the safety profile and to explore early signs of efficacy in different disease indications Patients will be randomly assigned to arm 1 monotherapy or arm 2 combination therapy 10 patients each
Both in part I and II patients can receive up to 4 consecutive cycles of radioligand therapy every 8 1 weeks
The primary objective of this study is to assess the safety of 177LuLu-OncoFAP-23 alone or in combination with L19-IL2 for the treatment of advancedmetastatic FAP-positive malignancies and to establish a Recommended Dose RD
Secondary objectives include evaluation of pharmacokinetics and the collection of initial signs of efficacy of the treatment
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