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New treatment option for Castration-Resistant Prostate Cancer (CRPC)
Official title 177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07189871
What this study is testing
What is 177Lu-BetaBart?
177Lu-BetaBart is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for castration-resistant prostate cancer (crpc).
Also referred to as RV-01, B335 177Lu-DOTA-anti-B7-H3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study...
- Participants ≥ 18 years of age.
- Participants with a documented history of histopathologically confirmed CRPC\ , CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial...
You likely can't join if
- below marked with \ refer to CRPC only, criteria without \ refer to all tumor indications including CRPC) a. \ Progressive CRPC defined as castrate...
- Participants must have documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory...
- Must have at least 1 measurable target lesion according to RECIST v1.1. (Note: this does not apply for CRPC)
- 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 are defined as those...
See the full eligibility criteria
Who can join
- Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
- 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. (Note: inclusion or
What rules you out
- below marked with \ refer to CRPC only, criteria without \ refer to all tumor indications including CRPC) a. \ Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following...
- 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...
- Must have at least 1 measurable target lesion according to RECIST v1.1. (Note: this does not apply for CRPC)
- 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 are defined as those who are not surgically sterile or post-menopausal. Participants will...
- Participants of CBP must agree to use a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4.
- Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 6 months after the last dose of...
- Participants who have received prior radiation therapy \>28 days before the first dose of 177Lu-BetaBart are permitted. Documentation of the dates the radiotherapy was received, the cumulative dose, and the absorbed...
- Participants with previously treated brain metastases are eligible to participate if:
- 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...
- 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 Criteria:
- History of prior organ transplant.
- Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received...
- 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 such as...
- Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia and peripheral sensory neuropathy).
- History of uncontrolled allergic reactions and/or known or expected hypersensitivity to protein therapeutics, 177Lu-BetaBart, or any of its excipients.
- Inadequate organ functions as reflected in laboratory parameters:
- 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 requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart are not eligible to participate.
- \ Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy.
- 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.
- Participation in any other treatment investigational trial for treatment of underlying malignancy at the time of informed consent signature.
- Participants who are pregnant or breastfeeding.
- 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 (or 5 half-lives for...
- 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...
- 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.
- Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.
- Untreated moderate to severe hydronephrosis. If hydronephrosis is corrected via stent or nephrostomy, hydronephrosis will be considered resolved.
- \ Prescence of a superscan by nuclear medicine/99mTc bone scan.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Grand Rapids, Michigan, United States
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Grand Rapids, Michigan, United States; Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.