NCT07189871RecruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

This is a Phase 1/2a dose escalation and expansion study to determine the safety, tolerability, and preliminary clinical activity of 177LuBetaBart, a lutetium-labeled anti-B7-H3 monoclonal antibody, in patients with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors

Status (registry): Recruiting
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 61 (estimated)
First submitted: 11 Sept 2025
Start date: Feb 2026
Primary completion date: Dec 2027
Lead sponsor: Radiopharm Theranostics, Ltd
Diseases: Prostate cancer, Triple-negative breast cancer, Head and neck cancer, Endometrial cancer, Cervical cancer, Lung cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer, Sarcoma
NCT number: NCT07189871

What you commit to

Study type: Interventional · Phase 1/2
Planned participants: 61
From Feb 2026 to the primary completion date, Dec 2027
5 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

History of prior organ transplant.
Residual toxicity ≥ Grade 2 from prior anti-cancer therapy
\*Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy.
Major surgery within 4 weeks prior to first dose of 177Lu-BetaBart.
Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, ≤ 28 days prior to the first dose of 177Lu-BetaBart.

Other illness

Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer.
Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures.
History of uncontrolled allergic reactions and/or known or expected hypersensitivity to protein therapeutics.
Clinically significant cardiovascular disease
Known active hepatitis B or known active hepatitis C infection.
Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s)
Active autoimmune disease that has required systemic treatment within 90 days.

Lab values

Inadequate organ functions as reflected in laboratory parameters:
- Estimated glomerular filtration rate (eGFR) \< 50 mL/min
- 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

Other

Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart.
Participation in any other interventional investigational trial
Participants who are pregnant or breastfeeding.
Untreated moderate to severe hydronephrosis
For CRPC participants, prescence of a superscan by nuclear medicine/99mTc bone scan.
Any other clinically significant comorbidities, 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.

Criteria the registry did not label

Participants ≥ 18 years of age.
Participants with a documented history of histopathologically confirmed CRPC\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC.
- \*Progressive CRPC defined by at least one of the following criteria: i. Two consecutive increases in PSA measured at least 1 week apart. ii. Soft tissue progression defined as a ≥20% increase in the sum of the diameter or the appearance of one or more new lesions by computed tomography (CT)/magnetic resonance imaging (MRI).
- Progression of bone disease defined by Prostate Cancer Working Group 3 (PCWG3) as evaluable disease or new bone lesions by bone scan.
- Identification of new soft tissue or bone lesions on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.
- \*Metastatic disease defined as either or both of the following: i. Documented M1 disease on conventional imaging ii. Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent c. \*Progression following treatment with ADT and at least one ARSI . e. Participants with liver metastases if they meet the following criteria: i. ≤3 lesions ii. All lesions must be ≤2 cm in the short axis iii. SUVmean ≥2 x that of liver parenchyma g. Participants with TNBC if pathology results confirm the following: i. Estrogen receptor expression \<1%, ii. Progesterone receptor expression \<1%, iii. Human epidermal growth factor receptor 2 (HER2) negative, defined as IHC 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH)
Participants must have documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit.
Must have at least 1 measurable target lesion according to RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.
Participants of child-bearing potential (CBP) must have a negative β-hCG test and must not be breastfeeding.
Participants of CBP must agree to use a highly effective method of contraception.
Participants with previously treated brain metastases are eligible to participate if:
- they are neurologically and radiologically stable for at least 28 days prior to the first dose of 177Lu-BetaBart; and
- have no history of leptomeningeal disease or spinal cord compression.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Dothan Hematology & Oncology Coordinator of this site? Confirm its status	Dothan	United States	Recruiting
BAMF Health Coordinator of this site? Confirm its status	Grand Rapids	United States	Recruiting
MD Anderson Cancer Center Coordinator of this site? Confirm its status	Houston	United States	Recruiting
XCancer Coordinator of this site? Confirm its status	Omaha	United States	Recruiting
Nebraska Cancer Specialists Coordinator of this site? Confirm its status	Omaha	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.