CancerNCT06980519
MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer
A study testing MNPR-101-PCTA-177Lu in people with Cancer and Solid Tumor, run by Monopar Therapeutics at 1 site in United States.
Trial summary
The purpose of this Expanded Access Program (EAP) is to allow use of the investigational therapeutic agent, MNPR-101-PCTA-177Lu, for treatment of urokinase plasminogen activator receptor (uPAR)-positive solid tumors identified via positron emission tomography / computed tomography (PET/CT) with investigational imaging… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Solid Tumor Cancer
- What is being tested?
- MNPR-101-PCTA-177Lu
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Participated in the Expanded Access Program (EAP) IST-00Ca study
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor cancer that is refractory to existing therapy(ies) known to provide clinical benefit, or for which no standard treatment is available, or is contraindicated
- Ability to understand and willingness to sign a written informed consent document
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
- Evidence of impaired organ function, particularly bone marrow, liver, kidney, or heart, according to specific test parameters
- Presence of other serious, non-malignant diseases or any other condition that, in the opinion of the investigator, could interfere with the objectives of the study, participant safety, or compliance
Trial locations and contacts
1 site in 1 country.
United States1 site
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, 77042
About this study
Official title: Treatment of Patients With Solid Tumor Cancers Via Intermediate-Size Patient Population Expanded Access Investigational New Drug (IND)
The purpose of this Expanded Access Program (EAP) is to allow use of the investigational therapeutic agent, MNPR-101-PCTA-177Lu, for treatment of urokinase plasminogen activator receptor (uPAR)-positive solid tumors identified via positron emission tomography / computed tomography (PET/CT) with investigational imaging agent MNPR-101-DFO*-89Zr.
Read the detailed description
This EAP will enroll patients with uPAR-positive solid tumor cancer confirmed by prior PET/CT imaging with MNPR-101-DFO*-89Zr (EAP IST-00Ca). Eligible patients will be treated with 1 cycle (as 2 fractionated doses) of investigational therapy, MNPR-101-PCTA-177Lu, at 1 of 4 planned dose levels. All enrolled patients will receive active treatment. Dosing of patients will begin at the lowest planned dose level. After 2 patients are dosed at a level, the next 2 patients may receive the next higher dose level, the same dose level, or a lower dose level, based upon the nature and severity of adverse reactions (side effects). The safety, tolerability, and potential antitumor effects (radiologic response) of MNPR-101-PCTA-177Lu will be evaluated over 12 weeks after dosing. The amount of radioactivity in blood samples will be checked over 4 weeks post dose. Patient survival will be followed up 6 months after the last dose received.
- Conditions
- Cancer, Solid Tumor, Solid Tumor Cancer, Oncology, uPAR-positive Solid Tumor, Urokinase Plasminogen Activator Receptor-positive Solid Tumor
- Being tested
- MNPR-101-PCTA-177Lu
- Keywords
- MNPR-101-PCTA-177Lu, SPECT, SPECT/CT, CT, Radiotherapy, Radiologic response, Single Photon Emission Computed Tomography, Computed Tomography, Monoclonal antibody radionuclide conjugate, Antibody radionuclide conjugate, Lutetium-177, Single Photon Emission Computed Tomography/Computed Tomography, Urokinase plasminogen activator receptor-positive, uPAR-positive, Positron emission tomography/computed tomography, PET/CT, EAP IST-00Ca
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNPR-101-PCTA-177LuBiological
MNPR-101-PCTA-177Lu is a monoclonal antibody-radionuclide conjugate intended to target and deliver radioactivity to solid tumors expressing uPAR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Monopar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ebrahim S. Delpassand, M.D. Chairman & Medical Director, Nuclear Medicine, Principal investigator, Excel Diagnostics & Nuclear Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980519
- Sponsor's protocol ID
- IST-00Cb
- Status last verified
- Sep 2026
- First submitted
- 12 May 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Solid Tumor Cancers Via Intermediate-Size Patient Population Expanded Access Investigational New Drug (IND)
- ClinicalTrials.gov ID
- NCT06980519
- Acronym / sponsor ID
- IST-00Cb
- Conditions
- Cancer, Solid Tumor, Solid Tumor Cancer, Oncology, uPAR-positive Solid Tumor, Urokinase Plasminogen Activator Receptor-positive Solid Tumor
- Keywords
- MNPR-101-PCTA-177Lu, SPECT, SPECT/CT, CT, Radiotherapy, Radiologic response, Single Photon Emission Computed Tomography, Computed Tomography
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Monopar TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 20 May 2025 (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.
The purpose of this Expanded Access Program (EAP) is to allow use of the investigational therapeutic agent, MNPR-101-PCTA-177Lu, for treatment of urokinase plasminogen activator receptor (uPAR)-positive solid tumors identified via positron emission tomography / computed tomography (PET/CT) with investigational imaging agent MNPR-101-DFO*-89Zr.
Detailed description
This EAP will enroll patients with uPAR-positive solid tumor cancer confirmed by prior PET/CT imaging with MNPR-101-DFO*-89Zr (EAP IST-00Ca). Eligible patients will be treated with 1 cycle (as 2 fractionated doses) of investigational therapy, MNPR-101-PCTA-177Lu, at 1 of 4 planned dose levels. All enrolled patients will receive active treatment. Dosing of patients will begin at the lowest planned dose level. After 2 patients are dosed at a level, the next 2 patients may receive the next higher dose level, the same dose level, or a lower dose level, based upon the nature and severity of adverse reactions (side effects). The safety, tolerability, and potential antitumor effects (radiologic response) of MNPR-101-PCTA-177Lu will be evaluated over 12 weeks after dosing. The amount of radioactivity in blood samples will be checked over 4 weeks post dose. Patient survival will be followed up 6 months after the last dose received.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participated in the Expanded Access Program (EAP) IST-00Ca study
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor cancer that is refractory to existing therapy(ies) known to provide clinical benefit, or for which no standard treatment is available, or is contraindicated
- Ability to understand and willingness to sign a written informed consent document
Key exclusion criteria (5 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
- Evidence of impaired organ function, particularly bone marrow, liver, kidney, or heart, according to specific test parameters
- Presence of other serious, non-malignant diseases or any other condition that, in the opinion of the investigator, could interfere with the objectives of the study, participant safety, or compliance
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 is a monoclonal antibody-radionuclide conjugate intended to target and deliver radioactivity to solid tumors expressing uPAR. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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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.
Ebrahim S. Delpassand, M.D. Chairman & Medical Director, Nuclear Medicine principal investigator
Excel Diagnostics & Nuclear Oncology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MNPR-101-PCTA-177Lu in people with Cancer and Solid Tumor, run by Monopar Therapeutics at 1 site in United States.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 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 United States. 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 4 Sep 2026.