Solid Tumor, AdultPhase 1NCT06617169

Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors

A Phase 1 study testing MNPR-101-PCTA-177Lu in people with Solid Tumor, Adult and Bladder Cancer, run by Monopar Therapeutics at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Adult, Bladder Cancer, Urothelial Carcinoma
What is being tested?: MNPR-101-PCTA-177Lu
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteAustralia
Study dates: 8 Oct 2024to Feb 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participated in the MNPR-101-D001 study.
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.
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.
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.

Who cannot join

Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-PCTA-177Lu.
Continuing ≥ Grade 3 adverse reactions from prior systemic therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
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.
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 <9g/dL (no red blood cell transfusion in the previous 4 weeks).
Liver function: i. AST/ALT >3xULN (institutional upper limits of normal) OR >5×ULN for patients with liver metastases.

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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].
Safety event of significance in MNPR-101-D001 study:
a related CTCAE Grade 4 hematologic or hepatologic event
a related CTCAE Grade 3 hematologic or hepatologic event which lasted >30 days
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.
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.
Cognitive impairment or contraindications that may compromise ability to give informed consent or comply with requirements of the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Melbourne Theranostic Innovation Centre (MTIC)
North Melbourne, Victoria, 3051

Other trials in Australia

About this study

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

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.

Read the 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 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.

Conditions: Solid Tumor, Adult, Bladder Cancer, Urothelial Carcinoma, Triple-negative Breast Cancer, Lung Cancer, Colorectal Cancer
Being tested: MNPR-101-PCTA-177Lu
Medical subject headings: Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Triple Negative Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MNPR-101-PCTA-177LuDrug
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.

Study groups in NCT06617169
Study group	Role	What they receive
Level 0 - MNPR-101-PCTA-177Lu 480 MBq	Experimental	Not described Receives: Drug: MNPR-101-PCTA-177Lu
Level 1 - MNPR-101-PCTA-177Lu 960 MBq	Experimental	Not described Receives: Drug: MNPR-101-PCTA-177Lu
Level 2 - MNPR-101-PCTA-177Lu 1440 MBq	Experimental	Not described Receives: Drug: MNPR-101-PCTA-177Lu
Level 3 - MNPR-101-PCTA-177Lu 1920 MBq	Experimental	Not described Receives: Drug: MNPR-101-PCTA-177Lu
Level 4 - MNPR-101-PCTA-177Lu 2240 MBq	Experimental	Not described Receives: Drug: MNPR-101-PCTA-177Lu

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: For 6 weeks after the first dose
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.
Measured: From dosing to the End of Study at 24 weeks

Secondary outcomes (4)

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).
Measured: Every 6 weeks after initial dose
Assessment of radiologic response rate by PERCIST 1.0
Radiologic response rate determined by PERCIST 1.0 via PET scans (non-CT measurable participants)
Measured: At 12 weeks after first dose (End of Cycle 1) and at 12 weeks after final dose (Safety Visit)
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.
Measured: for 2 weeks after each 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.
Measured: 6 weeks after the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 2024Feb 2027

First posted27 Sep 2024
Study start8 Oct 2024
Primary completionJan 2027 (estimated)
Study completionFeb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Participants will be dosed in cohorts of two, starting at Dose Level 1. TITE-BOIN evaluates the number of participants that have been dosed at a given dose level and their outcomes and determines if the next cohort should stay at the same dose, increase dose, or decrease dose using a predetermined rule.
Masking: None (open label)
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06617169
Sponsor's protocol ID: MNPR101-Lu-1-01
Status last verified: Sep 2026
First submitted: 18 Sep 2024
Last updated: 3 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
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RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor

All Solid Tumor, Adult trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06617169
Acronym / sponsor ID: MNPR101-Lu-1-01
Conditions: Solid Tumor, Adult, Bladder Cancer, Urothelial Carcinoma, Triple-negative Breast Cancer, Lung Cancer, Colorectal Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 12 participants (estimated)
Lead sponsor: Monopar TherapeuticsIndustry (pharma, biotech, devices)
Study start: 8 Oct 2024 (actual)
Primary completion: Jan 2027 (estimated)
Study completion: Feb 2027 (estimated)
First posted: 27 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Patients will be followed for safety for 12 weeks following the last dose of MNPR-101-PCTA-177Lu.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5
Model description: Participants will be dosed in cohorts of two, starting at Dose Level 1. TITE-BOIN evaluates the number of participants that have been dosed at a given dose level and their outcomes and determines if the next cohort should stay at the same dose, increase dose, or decrease dose using a predetermined rule.

Arm	Type	Receives
Level 0 - MNPR-101-PCTA-177Lu 480 MBq	Experimental	Drug: MNPR-101-PCTA-177Lu
Level 1 - MNPR-101-PCTA-177Lu 960 MBq	Experimental	Drug: MNPR-101-PCTA-177Lu
Level 2 - MNPR-101-PCTA-177Lu 1440 MBq	Experimental	Drug: MNPR-101-PCTA-177Lu
Level 3 - MNPR-101-PCTA-177Lu 1920 MBq	Experimental	Drug: MNPR-101-PCTA-177Lu
Level 4 - MNPR-101-PCTA-177Lu 2240 MBq	Experimental	Drug: MNPR-101-PCTA-177Lu

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participated in the MNPR-101-D001 study.
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.
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.
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.

Key exclusion criteria (14 listed)

Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-PCTA-177Lu.
Continuing ≥ Grade 3 adverse reactions from prior systemic therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
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.
Have evidence of impaired organ function at Screening and prior to dosing, particularly:
Safety event of significance in MNPR-101-D001 study:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MNPR-101-PCTA-177LuMNPR-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.	Drug	Level 0 - MNPR-101-PCTA-177Lu 480 MBq, Level 1 - MNPR-101-PCTA-177Lu 960 MBq, Level 2 - MNPR-101-PCTA-177Lu 1440 MBq, Level 3 - MNPR-101-PCTA-177Lu 1920 MBq, Level 4 - MNPR-101-PCTA-177Lu 2240 MBq

Primary outcome

Identify the dose-limiting toxicities (DLTs) of fractionated MNPR-101-PCTA-177Lu dosing and their frequency
Time frame: For 6 weeks after the first dose
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.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of fractionated MNPR-101-PCTA-177Lu dosing
Time frame: From dosing to the End of Study at 24 weeks
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.

4 secondary outcomes

Assessment radiologic response rate by RECIST 1.1
Time frame: Every 6 weeks after initial dose
Assessment of radiologic response rate by PERCIST 1.0
Time frame: At 12 weeks after first dose (End of Cycle 1) and at 12 weeks after final dose (Safety Visit)
Assess Radioactivity in whole blood and plasma following each fractionated MNPR-101-PCTA-177Lu dose
Time frame: for 2 weeks after each dose
To determine the maximum administered dose (MAD) for fractionated MNPR-101-PCTA-177Lu dosing
Time frame: 6 weeks after the first dose

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Solid Tumor, Adult

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MNPR-101-PCTA-177Lu in people with Solid Tumor, Adult and Bladder Cancer, run by Monopar Therapeutics at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify the dose-limiting toxicities (DLTs) of fractionated MNPR-101-PCTA-177Lu dosing and their frequency (time frame: For 6 weeks after the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06617169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.