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Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors
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.
Study details:
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 MBq). On 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, i.
e. , 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 1. 1.
Patients will be followed for safety for 12 weeks following the last dose of MNPR-101-PCTA-177Lu.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-10-01
Primary completion: 2025-06-01
Study completion finish: 2025-06-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06617169
Intervention or treatment
DRUG: MNPR-101-PCTA-177Lu
Conditions
- • Solid Tumor, Adult
- • Bladder Cancer
- • Urothelial Carcinoma
- • Triple-negative Breast Cancer
- • Lung Cancer
- • Colorectal Cancer
- • Gastric Cancer
- • Ovarian Cancer
- • Pancreatic Cancer
Find a site
Closest Location:
Melbourne Theranostic Innovation Centre (MTIC)
Research sites nearby
Select from list below to view details:
Melbourne Theranostic Innovation Centre (MTIC)
North Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Level 0 - MNPR-101-PCTA-177Lu 480 MBq
| DRUG: MNPR-101-PCTA-177Lu
|
EXPERIMENTAL: Level 1 - MNPR-101-PCTA-177Lu 960 MBq
| DRUG: MNPR-101-PCTA-177Lu
|
EXPERIMENTAL: Level 2 - MNPR-101-PCTA-177Lu 1440 MBq
| DRUG: MNPR-101-PCTA-177Lu
|
EXPERIMENTAL: Level 3 - MNPR-101-PCTA-177Lu 1920 MBq
| DRUG: MNPR-101-PCTA-177Lu
|
EXPERIMENTAL: Level 4 - MNPR-101-PCTA-177Lu 2240 MBq
| DRUG: MNPR-101-PCTA-177Lu
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of fractionated MNPR-101-PCTA-177Lu dosing | The safety profile of MNPR-101-PCTA-177Lu will be determined through assessment of adverse event (AE) type, incidence, severity, time of appearance, and related causes (detected by physical explorations and laboratory tests). Adverse events will be graded and tabulated using NCI CTCAE v5.0. | From dosing to the End of Study at 24 weeks |
Identify the dose-limiting toxicities (DLTs) of fractionated MNPR-101-PCTA-177Lu dosing and their frequency | Dose-limiting toxicities (DLT) are at least possibly related to MNPR-101-PCTA-177Lu and occur within 6 weeks of C1D1. Participants experiencing a DLT will not receive any further doses. Participants will continue study participation through the 12-week post final dose Safety Visit. | For 6 weeks after the first dose |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Assessment radiologic response rate by RECIST 1.1 | Radiologic response rate will be determined by RECIST 1.1 via CT scans every 6 weeks (3 timepoints). | Every 6 weeks after initial dose |
To determine the maximum administered dose (MAD) for fractionated MNPR-101-PCTA-177Lu dosing | The maximum administered dose will be determined by the highest dose of MNPR-101-PCTA-177Lu not eliminated by TITE-BOIN. | 6 weeks after the first dose |
Assess Radioactivity in whole blood and plasma following each fractionated MNPR-101-PCTA-177Lu dose | Radioactivity in whole blood and plasma for each fractionated MNPR-101-PCTA-177Lu are projected via time-corrected gamma counts. | for 2 weeks after each dose |
Frequently Asked Questions
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