Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617169
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open Label Phase 1a Dose-Escalation Study Evaluating the Safety of Fractionated MNPR-101-PCTA-177Lu Dosing in the Treatment of Solid Tumor Cancers
Status:
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 is an open-label uncontrolled multi-center phase 1a MNPR-101-PCTA-177Lu dose-escalation study in patients with solid tumor cancers Patients must have participated in the imaging study MNPR-101-D001 actively recruiting diagnostic study of MNPR-101-DFO-89Zr
TITE-BOIN will be used to objectively determine dose increase no dose change or dose decrease for each group of two patients
The treatment period consists of two 12-week cycles Patients will receive three equal fractions of MNPR-101-PCTA-177Lu with radioactivity ranging from 480-2240 MBq on each of Cycle 1 Day 1 Cycle 1 Day 15 and Cycle 2 Day 1 12 weeks after Cycle 1 Day 1
Patients will be followed for 12 weeks after their last dose of MNPR-101-PCTA-177Lu
Patients will be imaged at specific timepoints during the study
TITE-BOIN will be used to objectively determine dose increase no dose change or dose decrease for each group of two patients
The treatment period consists of two 12-week cycles Patients will receive three equal fractions of MNPR-101-PCTA-177Lu with radioactivity ranging from 480-2240 MBq on each of Cycle 1 Day 1 Cycle 1 Day 15 and Cycle 2 Day 1 12 weeks after Cycle 1 Day 1
Patients will be followed for 12 weeks after their last dose of MNPR-101-PCTA-177Lu
Patients will be imaged at specific timepoints during the study
Detailed Description:
This Phase 1a study will enroll qualified participants from the MNPR-101-D001 imaging study Patients will receive three equal doses of MNPR-101-PCTA-177Lu dose-escalating in cohorts of two starting at Dose Level 1 960 MBqOn Cycle 1 Day 1 Cycle 1 Day 15 and Cycle 2 Day 1 patients will receive a 20-minute intravenous infusion of MNPR-101-PCTA-177Lu consisting of an antibody with radioactivity ranging from 480-2240 MBq Dose Levels 0-4
This study employs a Time-to-Event Bayesian Optimal Interval Design TITE-BOIN Dosing of subsequent cohorts will escalate stay or de-escalate based on TITE-BOIN predetermined fixed dose escalation de-escalation rules
Any hematologic event must be Grade 1 for dosing to occur ie patients with an active Grade 2 hematologic event may not be dosed Any patient experiencing a Grade 2 allergic reaction during or immediately following infusion will not receive further treatment Patients experiencing a DLT at least possibly related to MNPR-101-PCTA-177Lu and occurring within 6 weeks of C1D1 will not receive any further doses C1D15 and C2D1 doses may be delayed for up to 14 days for specified adverse events
All subjects will undergo SPECT imaging on Cycle 1 Day 8 and Cycle 2 Day 8 CT scans will occur on Cycle 1 Day 43 Cycle 2 Day 1 and Cycle 2 Day 43 a baseline CT scan must be provided These will allow for the assessment of tumor SUVs as well as the radiologic response rate by RECIST 11
Patients will be followed for safety for 12 weeks following the last dose of MNPR-101-PCTA-177Lu
This study employs a Time-to-Event Bayesian Optimal Interval Design TITE-BOIN Dosing of subsequent cohorts will escalate stay or de-escalate based on TITE-BOIN predetermined fixed dose escalation de-escalation rules
Any hematologic event must be Grade 1 for dosing to occur ie patients with an active Grade 2 hematologic event may not be dosed Any patient experiencing a Grade 2 allergic reaction during or immediately following infusion will not receive further treatment Patients experiencing a DLT at least possibly related to MNPR-101-PCTA-177Lu and occurring within 6 weeks of C1D1 will not receive any further doses C1D15 and C2D1 doses may be delayed for up to 14 days for specified adverse events
All subjects will undergo SPECT imaging on Cycle 1 Day 8 and Cycle 2 Day 8 CT scans will occur on Cycle 1 Day 43 Cycle 2 Day 1 and Cycle 2 Day 43 a baseline CT scan must be provided These will allow for the assessment of tumor SUVs as well as the radiologic response rate by RECIST 11
Patients will be followed for safety for 12 weeks following the last dose of MNPR-101-PCTA-177Lu
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