New hope for advanced cancer: experimental drug targets Hard-to-Treat tumors
NCT ID NCT07505771
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 9 times
Summary
This early-phase study is testing an experimental drug called 177Lu-IM-3050 in adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety and find the best dose. About 105 participants will receive the drug to see if it can help control their cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2034
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥18 years of age * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1 or 2 * Histological or cytological diagnosis of a solid tumor * Participants must be refractory to or have relapsed after at least one prior standard therapeutic regimen. Participants must be relapsed or refractory to, have developed an intolerance to, or not be candidates for available therapies with established benefit. * Participants must have measurable disease as per RECIST v.1.1 based on imaging performed during Screening. * During Part A only, participants without measurable disease per RECIST v1.1 are eligible if approved by Medical Monitor. * During screening, participants must have positive FAP PET/CT uptake as described in criteria for continuation of IM-3050 treatment. * Participants must have adequate organ function. Exclusion Criteria: * Participant has received certain prior radiation therapy as detailed in the protocol * Participant has undergone major surgery within 4 weeks or minor surgery within 2 weeks of starting 177Lu-IM-3050 or has known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis. * Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 2 years and approved by the Medical Monitor. Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers. * Recent or ongoing serious infection or other significant medical condition as detailed in the protocol. * Participant has received an investigational product or been treated with an investigational device within 30 days, or 5 half-lives prior to receiving the FAP PET/CT imaging tracer or 177Lu-IM-3050.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Excel Diagnostics and Nuclear Oncology Center
RECRUITINGHouston, Texas, 77042, United States
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Stanford University School of Medicine
RECRUITINGPalo Alto, California, 94305, United States
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University of Texas - MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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XCancer Research Network / Dothan Hematology & Oncology
RECRUITINGDothan, Alabama, 36303, United States
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Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
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- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors