BridgeMD
New treatment option for Castration-resistant Prostate Cancer
Official title A Study of Terbium 161 (161Tb)-RAD402 in Participants With CRPC
ClinicalTrials.gov ID: NCT07259213
What this study is testing
What is 161Tb RAD402?
161Tb RAD402 is an investigational medicine, being studied as a potential treatment for castration-resistant prostate cancer.
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 Study to Evaluate the Safety, Tolerability, Whole-Body Distribution, and Preliminary Clinical Activity of 161Tb-RAD402, a Radiolabeled Anti-KLK3 Monoclonal Antibody Targeting Free Prostate-Specific Antigen, in Participants with Castration-Resistant Prostate Cancer (CRPC).
- 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, men only
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...
- Male participants ≥ 18 years of age.
- Participants with a documented history of histopathologically confirmed locally advanced or metastatic CRPC defined as follows:
- Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria:
- Serum PSA increase \>25% and \>2.0 ng/ml above nadir, confirmed by progression at 2 timepoints at least 3 weeks apart (PCWG3)
You likely can't join if
- Prostate cancer with known significant sarcomatoid, or spindle cell, or neuroendocrine small cell components, or metastasis of other cancer to the...
- History of prior organ transplant (other than corneal transplant)
- Any other known, active malignancy except for non-melanoma skin cancer or adequately treated non-muscle-invasive urothelial carcinoma of the bladder...
- Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to...
- 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, 161Tb-RAD402, or any of its excipients.
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.
- Male participants ≥ 18 years of age.
- Participants with a documented history of histopathologically confirmed locally advanced or metastatic CRPC defined as follows:
- Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria:
- Serum PSA increase \>25% and \>2.0 ng/ml above nadir, confirmed by progression at 2 timepoints at least 3 weeks apart (PCWG3)
- Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the...
- Progression of bone disease defined by PCWG3 as evaluable disease or new bone lesions by bone scan (if metastatic disease).
- Identification of new soft tissue or bone lesions on PSMA PET imaging.
- If metastatic disease, metastatic disease defined as either or both of the following:
- Documented M1 disease on conventional imaging (CT/MRI of the chest/abdomen/pelvis and/or Technetium 99m [99mTc] whole-body bone scan)
- Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent (e.g., Gallium-68 (68Ga)-PSMA-11)
- PSMA PET-positive disease, defined as at least one PSMA-positive metastatic lesion PSMA PET-positive lesions are defined as uptake greater than that of liver parenchyma in one or more extra-pelvic metastatic lesions of...
- Progression following treatment with androgen deprivation therapy (ADT) and at least one androgen receptor signaling inhibitor (ARSI) (e.g., enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate). If a...
- Prior definitive and palliative external beam radiation therapy and stereotactic body radiation therapy is allowed. Note: Participants with extended external beam radiation therapy to the axial skeleton, which in the...
- Prior treatment with lutetium (Lu-177)-PSMA-radioligand (RL), defined as up to 6 doses of lutetium (177Lu) vipivotide tetraxetan (Pluvicto) or investigational use of up to 4 doses of Lu-177-PSMA-imaging and treatment...
- Participants must have documented disease progression during or after their most recent line of anticancer therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.
- 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 161Tb-RAD402...
- 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 at a dose of \>10 mg prednisolone equivalent to treat associated neurological symptoms, and
- have no history of leptomeningeal disease or spinal cord compression.
What rules you out
- Prostate cancer with known significant sarcomatoid, or spindle cell, or neuroendocrine small cell components, or metastasis of other cancer to the prostate.
- History of prior organ transplant (other than corneal transplant)
- Any other known, active malignancy except for non-melanoma skin cancer or adequately treated non-muscle-invasive urothelial carcinoma of the bladder (i.e. tumor in situ (Tis), tumor grade a (Ta) and low-grade tumor...
- 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, 161Tb-RAD402, or any of its excipients.
- Inadequate organ functions as reflected in laboratory parameters:
- Estimated glomerular filtration rate (eGFR) \< 50 mL/min adjusted for body surface area (BSA) using the Chronic Kidney Disease Epidemiology Collaboration 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: International Normalised Ratio (INR) ≤1.5 or PT ≤1.5 x ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT)...
- Participants requiring blood product transfusion within 2 weeks of first dose of 161Tb-RAD402 are not eligible to participate.
- 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 electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block)
- Known left ventricular ejection fraction (LVEF) \< 50%
- QT corrected using Fridericia's formula (QTcF) \> 480 msec on screening ECG, or congenital long QT syndrome.
- Participation in any other treatment investigational trial for treatment of the underlying malignancy at the time of informed consent signature.
- Major surgery within 4 weeks prior to first dose of 161Tb-RAD402.
- Received prior therapy with a poly (ADP-ribose) polymerase (PARP) inhibitor or radium Ra 223 dichloride (Xofigo). Prior treatment with Lu-177-PSMA-radioligand (RL) is allowed.
- Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 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 (HCV) (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection. Active viral (any...
- 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.
- Superscans 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 (e.g., prior organ transplant), which in the judgment of the investigator could compromise...
The study team makes the final eligibility decision.
Where it's taking place
- Wollongong, New South Wales, Australia
- Nedlands, Western Australia, Australia
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 male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wollongong, New South Wales, Australia; Nedlands, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.