Study of 177Lu-BetaBart for Advanced Solid Tumors
This study is testing a treatment called 177Lu-BetaBart for people with certain types of advanced solid tumors that have returned or are hard to treat. These include castration-resistant prostate cancer, colorectal cancer, non-small cell lung cancer, ovarian cancer, and cervical cancer. 177Lu-BetaBart is a monoclonal antibody, which is a type of protein that can target specific cells. The study aims to find the safest and most effective dose of 177Lu-BetaBart and see if it can shrink tumors. You would receive 177Lu-BetaBart through an IV every 6 weeks. The study is currently recruiting participants.
- Study design
- This is a two-phase study with a planned enrollment of 61 participants. Phase 1 will determine the best dose, and Phase 2a will further evaluate safety and anti-tumor activity.
- What's involved
- You would receive 177Lu-BetaBart by IV infusion every 6 weeks. The study will assess your safety for at least 6 weeks and preliminary anti-tumor activity for up to 30 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess preliminary anti-tumor activity for up to 30 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07189871
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentRadiopharm Theranostics, Ltd
~61 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:177Lu-BetaBart
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended dose(s) of 177Lu-BetaBart for future exploration (phase 1)
Measured over 6 weeks
+3 more outcomes measured
Conditions
Where it's being run
4 sites across 3 statesNebraska2
Alabama1
Michigan1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \[MRI or CT scan\] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-BetaBart; and
do not require corticosteroids to treat associated neurological symptoms or if required, are on a stable dose of corticosteroids not exceeding 10 mg/day of prednisone (or equivalent), and
have no history of leptomeningeal disease or spinal cord compression.
Exclusion
Estimated glomerular filtration rate (eGFR) \< 50 mL/min adjusted for participant's body surface area using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula
Platelet count of \< 100 x 109/L
Absolute neutrophil count (ANC) \< 1.5 x 109/L
Hemoglobin \< 9 g/dL
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 x upper limit of normal (ULN), or \> 5 x ULN for participants with known liver metastases
Total bilirubin \> 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 x ULN
For participants not taking warfarin or other anticoagulants: INR ≤1.5 or PT ≤1.5 x ULN; and either PTT or aPTT ≤1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \<3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant. 7. Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart are not eligible to participate. 8. \*Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy. 9. Clinically significant cardiovascular disease including but not limited to:
Unstable angina
Acute myocardial infarction within 6 months prior to screening
New York Heart Association (NYHA) Class II or greater congestive heart failure
Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g., complete left bundle branch block, third degree heart block)
Known left ventricular ejection fraction \< 50%
QTcF \> 480 msec on screening electrocardiogram (ECG), or congenital long QT syndrome. 10. Participation in any other interventional investigational trial for treatment of underlying malignancy at the time of informed consent signature. 11. Participants who are pregnant or breastfeeding. 12. Major surgery within 4 weeks prior to first dose of 177Lu-BetaBart. 13. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, ≤ 28 days (or 5 half-lives for biologic/non-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-BetaBart. 14. Known active hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.
Active viral (any etiology) hepatitis participants are excluded.
Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer \< 1000 cps/mL or 200 IU/mL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor (or designee).
Note, participants with a history of HCV infection should have completed curative antiviral treatment and have a viral load below the limit of quantification to be eligible to enroll into the study.
No testing for HBV or HCV is required unless mandated by local health authority. 15. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy. 16. Untreated moderate to severe hydronephrosis. If hydronephrosis is corrected via stent or nephrostomy, hydronephrosis will be considered resolved. 17. \*Prescence of a superscan by nuclear medicine/99mTc bone scan. 18. Active autoimmune disease that has required systemic treatment within 90 days (i.e., with the use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid \[stable / low doses of ≤10 mg/day prednisone or equivalent dose\]) for adrenal or pituitary insufficiency is allowed. 19. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the investigator could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the subject to safety risks.
What this trial measures
- Recommended dose(s) of 177Lu-BetaBart for future exploration (phase 1)6 weeks
Incidence of dose-limiting toxicities (DLTs) during the 6 weeks following the first 177Lu-BetaBart injection
- Incidence of treatment emergent adverse events of 177-Lu-BetaBart (phase 1) (Safety and Tolerability)6 weeks
As defined per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- To assess the preliminary anti-tumor activity of 177Lu-BetaBart at the RP2D (phase 2a)Up to 30 weeks
Objective response rates (ORR) as assessed by RECIST v1.1
- To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants who are treated with 177Lu-BetaBart at the RP2D (phase 2a)Up to 30 weeks
Proportion of participants who achieve a best response of prostate-specific antigen (PSA)50