No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
61 (estimated)
Sponsor
Radiopharm Theranostics, Ltd · Industry
Who this trial is looking for
This trial is looking for adults with certain types of advanced cancer who have had no success with other treatments. Participants will receive an experimental treatment called 177Lu-BetaBart and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with advanced cancer that hasn’t responded to treatment.
I have had disease progression during or after my last cancer treatment.
I have one measurable tumor that can be assessed.
I agree to follow all study procedures.
I have a life expectancy of at least 4 months.
I can give informed consent before starting the trial.
I am neurologically stable if I have had brain metastases.
You may not be able to join if
I have had an organ transplant.
I have any other active cancer that is not treated.
I am currently breastfeeding.
I require corticosteroids for neurological symptoms.
I have a history of leptomeningeal disease.
I have a history of spinal cord compression.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
1. Participants ≥ 18 years of age.
2. Participants with a documented history of histopathologically confirmed CRPC\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC.
a. \*Progressive CRPC defined by at least one of the following criteria: i. Two conse…
1. Participants ≥ 18 years of age.
2. Participants with a documented history of histopathologically confirmed CRPC\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC.
a. \*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).
iii. Progression of bone disease defined by Prostate Cancer Working Group 3 (PCWG3) as evaluable disease or new bone lesions by bone scan.
iv. Identification of new soft tissue or bone lesions on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.
b. \*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)
3. 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.
4. Must have at least 1 measurable target lesion according to RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
6. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.
7. Participants of child-bearing potential (CBP) must have a negative β-hCG test and must not be breastfeeding.
8. Participants of CBP must agree to use a highly effective method of contraception.
9. 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.
Exclusion Criteria:
1. History of prior organ transplant.
2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer.
3. 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.
4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy
5. History of uncontrolled allergic reactions and/or known or expected hypersensitivity to protein therapeutics.
6. 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
7. Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart.
8. \*Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy.
9. Clinically significant cardiovascular disease
10. Participation in any other interventional investigational trial
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 prior to the first dose of 177Lu-BetaBart.
14. Known active hepatitis B or known active hepatitis C infection.
15. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s)
16. Untreated moderate to severe hydronephrosis
17. For CRPC participants, prescence of a superscan by nuclear medicine/99mTc bone scan.
18. Active autoimmune disease that has required systemic treatment within 90 days.
19. 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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.