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New treatment option for PDL1 Gene Mutation
Official title 177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06305962
What this study is testing
What is 177Lu-RAD204?
177Lu-RAD204 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for pdl1 gene mutation.
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
- This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to identify the MTDs/ recommended doses of 177Lu-RAD204 for future exploration. The study will consist of a Pre-screening Period (if applicable for PD-L1 testing), a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and dosimetry to 177Lu-RAD204im and a Phase I (Treatment) Period for 177Lu-RAD204tr dose escalation.
- Phase 1: an early, usually small safety study
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...
- Adult participants ≥ 18 years of age.
- Participants with a documented history of histopathologically confirmed relapsed/refractory locally advanced, inoperable or metastatic NSCLC, SCLC...
- Participants with PD-L1 positive NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or...
- If the participant tumour's PD-L1 expression status is unknown, PD-L1 positivity may be determined in a pre-screening step whereby the participant...
You likely can't join if
- History of prior organ transplant.
- Any other known, active malignancy, except for treated cervical intraepithelial neoplasia or non-melanoma skin cancer. Patients with a history of...
- 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).
- History of uncontrolled allergic reactions and/or known or expected hypersensitivity to protein therapeutics, 177Lu-RAD204 or any of its excipients.
- Inadequate organ functions as reflected in laboratory parameters:
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.
- Adult participants ≥ 18 years of age.
- Participants with a documented history of histopathologically confirmed relapsed/refractory locally advanced, inoperable or metastatic NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that...
- Participants with PD-L1 positive NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high:
- If the participant tumour's PD-L1 expression status is unknown, PD-L1 positivity may be determined in a pre-screening step whereby the participant may be approached to provide written informed consent to have their...
- Any number of prior treatment lines are allowed.
- Must have at least 1 measurable target lesion according to RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.
- Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal...
- WOCBP must agree to use a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and/or 6 months after the last dose of 177Lu-RAD204tr, whichever occurs...
- 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 14 days after the last injection of...
- 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 [magnetic resonance imaging (MRI) or computed tomography (CT) scan] must be used for each assessment) for...
- do not require steroids to treat associated neurological symptoms, and
- have no history of leptomeningeal disease or spinal cord compression.
- Participants with active brain metastases who have not received brain-directed therapy such as radiotherapy are not eligible to enroll.
- For Phase I:
- Participants must have positive lesion(s) by 177Lu-RAD204im SPECT/CT per central review as described in Image Review Charter, and
- Participants without any positive lesion by 177Lu-RAD204im SPECT/CT, e.g. due to poor image quality, may be allowed to enrol on a case-by-case basis at the discretion of the Principal Investigator and in discussion with...
What rules you out
- History of prior organ transplant.
- Any other known, active malignancy, except for treated cervical intraepithelial neoplasia or non-melanoma skin cancer. Patients 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).
- History of uncontrolled allergic reactions and/or known or expected hypersensitivity to protein therapeutics, 177Lu-RAD204 or any of its excipients.
- Inadequate organ functions as reflected in laboratory parameters:
- Creatinine clearance or body surface area (BSA) adjusted estimated glomerular filtration rate (eGFR) (calculated using any clinically validated formula, preferably Chronic Kidney Disease Epidemiology Collaboration...
- Platelet count of \< 80 × 109/L
- Absolute neutrophil count (ANC) \< 1.5 × 109/L
- Haemoglobin \< 9 g/dL
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × ULN, or \> 5 × ULN for patients with known liver metastases
- Total bilirubin \> 1.5 × ULN, except for patients with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 × ULN
- For participants not taking warfarin or other anticoagulants: international normalized ratio (INR) ≥ 1.5 or prothrombin time (PT) ≥ 1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin...
- Patients requiring blood product transfusion within 4 weeks of first dose of 177Lu-RAD204tr 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 (see Section 20.6)
- Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g. complete left bundle branch block, third degree heart block)
- Uncontrolled hypertension
- Known LVEF \< 50%
- QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 msec for females and QTcF \> 450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome.
- Participation in any other investigational trial at the time of informed consent signature.
- Pregnant or lactating women. The following exclusion criteria applies to participants in Phase I:
- 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...
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX 40, CD137), and was discontinued from...
- Has had or is scheduled to have major surgery \< 28 days prior to the first dose of 177Lu-RAD204tr.Surgical procedures not considered to put participants at higher risk of AEs and/or interfere with the integrity of...
- Positive status for human immunodeficiency virus (HIV).
- Active or chronic hepatitis B or C. Chronic hepatitis B or hepatitis C with undetectable viral loads on stable suppression therapy may be allowed on a case-by-case basis in discussion with study Sponsor.
- Any medical condition which, in the opinion of the Investigator, places the participant at an unacceptably high risk for toxicities.
- Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Kingswood, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Southport, Queensland, Australia
- Adelaide, South Australia, Australia
- Murdoch, 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingswood, New South Wales, Australia; Wollongong, New South Wales, Australia; Southport, Queensland, Australia; Adelaide, South Australia, Australia; Murdoch, 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.