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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06617169




Registration number
NCT06617169
Ethics application status
Date submitted
18/09/2024
Date registered
27/09/2024

Titles & IDs
Public title
Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors
Scientific 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
Secondary ID [1] 0 0
MNPR101-Lu-1-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
Bladder Cancer 0 0
Urothelial Carcinoma 0 0
Triple-negative Breast Cancer 0 0
Lung Cancer 0 0
Colorectal Cancer 0 0
Gastric Cancer 0 0
Ovarian Cancer 0 0
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MNPR-101-PCTA-177Lu

Experimental: Level 0 - MNPR-101-PCTA-177Lu 480 MBq -

Experimental: Level 1 - MNPR-101-PCTA-177Lu 960 MBq -

Experimental: Level 2 - MNPR-101-PCTA-177Lu 1440 MBq -

Experimental: Level 3 - MNPR-101-PCTA-177Lu 1920 MBq -

Experimental: Level 4 - MNPR-101-PCTA-177Lu 2240 MBq -


Treatment: Drugs: MNPR-101-PCTA-177Lu
MNPR-101-PCTA-177Lu administered intravenously over approximately 20 minutes, followed by a normal saline flush. Dosing will occur on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of fractionated MNPR-101-PCTA-177Lu dosing
Timepoint [1] 0 0
From dosing to the End of Study at 24 weeks
Primary outcome [2] 0 0
Identify the dose-limiting toxicities (DLTs) of fractionated MNPR-101-PCTA-177Lu dosing and their frequency
Timepoint [2] 0 0
For 6 weeks after the first dose
Secondary outcome [1] 0 0
Assessment radiologic response rate by RECIST 1.1
Timepoint [1] 0 0
Every 6 weeks after initial dose
Secondary outcome [2] 0 0
To determine the maximum administered dose (MAD) for fractionated MNPR-101-PCTA-177Lu dosing
Timepoint [2] 0 0
6 weeks after the first dose
Secondary outcome [3] 0 0
Assess Radioactivity in whole blood and plasma following each fractionated MNPR-101-PCTA-177Lu dose
Timepoint [3] 0 0
for 2 weeks after each dose

Eligibility
Key inclusion criteria
1. Participated in the MNPR-101-D001 study.
2. Females of childbearing potential must have a negative serum pregnancy test at time of screening and a negative urine pregnancy test on Day 1 prior to study drug administration if screening is >7 days prior to Day 1. A rapid serum pregnancy test result performed as standard of care will be accepted if available.
3. Both males and females must agree to use highly effective contraceptive precautions if conception is possible during the dosing period and up to 3 months after dosing.
4. Female patients who are lactating must agree to discontinue breastfeeding prior to the dose of study drug and must refrain from breastfeeding for 3 months following the last dose of study drug.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-PCTA-177Lu.
2. Continuing = Grade 3 adverse reactions from prior systemic therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
3. Prior treatment with any radiopharmaceutical or investigational agents within 4 weeks or 5 half-lives, whichever is longer, prior to administration of the first dose of MNPR-101-PCTA-177Lu other than MNPR-101-DFO*-89Zr.
4. Patients requiring blood product transfusion within 4 weeks prior to dosing.
5. Have evidence of impaired organ function at Screening and prior to dosing, particularly:

• Bone marrow: i. Platelets =150×10^9/L. ii. Absolute neutrophil count =1.5×10^9/L. iii. Hemoglobin =10g/dL (no red blood cell transfusion in the previous 4 weeks).

• Liver function: i. AST/ALT >2.5xULN (institutional upper limits of normal) OR >5×ULN for patients with liver metastases.

ii. Bilirubin >1.5xULN OR >3xULN for patients with known Gilbert's Syndrome.

• Renal function: i. eGFR =45 mL/min determined using BSA-adjusted Chronic Kidney Disease Epidemiology Collaboration CKD-EPI 2021 formula [https://www.kidney.org/professionals/kdoqi/gfr_calculator].
6. Safety event of significance in MNPR-101-D001 study:

1. a related CTCAE Grade 4 hematologic or hepatologic event
2. a related CTCAE Grade 3 hematologic or hepatologic event which lasted >30 days
7. Unacceptable value for projected organ dose based upon dosimetry from the MNPR-101-D001 study that exceeds safe absorbed dose limits, as determined by Monopar.
8. Other serious, non-malignant diseases (e.g., renal, hepatic, or hematologic) that may interfere with objectives of the study, safety, or compliance, as judged by the investigator.
9. Cognitive impairment or contraindications that may compromise ability to give informed consent or comply with requirements of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Theranostic Innovation Centre (MTIC) - North Melbourne
Recruitment postcode(s) [1] 0 0
3051 - North Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Monopar Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Director Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
847-794-8435
Fax 0 0
Email 0 0
monitoring@monopartx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06617169