RecruitingPhase 1Phase 2NCT07189871

177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors


Sponsor

Radiopharm Theranostics, Ltd

Enrollment

61 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase 1/2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radioactive drug called 177Lu-BetaBart for people with various types of advanced solid tumors that have not responded to standard treatments. The drug delivers targeted radiation directly to cancer cells. **You may be eligible if...** - You are 18 or older - You have been diagnosed with one of the following cancers that has come back or spread: prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck cancer, ovarian cancer, cervical cancer, endometrial cancer, triple-negative breast cancer, or esophageal squamous cell cancer - For prostate cancer: your PSA is rising and your cancer is progressing despite hormone therapy - Your cancer is progressing based on blood tests, imaging, or bone scans - You are willing to comply with all study procedures **You may NOT be eligible if...** - Your cancer does not match one of the eligible types - Your organ function (kidneys, liver, blood counts) does not meet study requirements - You are unable or unwilling to follow study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG177Lu-BetaBart

BetaBart administered by intravenous (IV) infusion every 6 weeks


Locations(4)

Dothan Hematology & Oncology

Dothan, Alabama, United States

BAMF Health

Grand Rapids, Michigan, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

XCancer

Omaha, Nebraska, United States

View Full Details on ClinicalTrials.gov

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NCT07189871


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