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Phase 0/1 Study of Safety and Dose Finding of 177Lu-RAD204, a Radiolabeled Antibody Against PD-L1, in Patients With Metastatic Solid Tumors
Led by Radiopharm Theranostics, Ltd · Updated on 2026-02-19
30
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in a Phase 0/1 study involving participants with advanced solid tumors that express PD-L1. The study aims to assess the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor effects of this treatment. The main goal is to find the maximum tolerated dose and recommended doses for future studies in participants with cancers such as NSCLC, SCLC, triple-negative breast cancer, melanoma, head and neck cancer, endometrial cancer, and others with specific genetic markers. The study includes a pre-screening period for PD-L1 testing if needed, followed by a screening period lasting up to four weeks. Participants undergo a Phase 0 Imaging Period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and dosimetry over two weeks. This may be followed by a Phase 1 Treatment Period with escalating doses of 177Lu-RAD204 administered in cycles lasting six weeks each. Participants may receive multiple treatment cycles based on clinical benefit and safety evaluations. Dose-limiting toxicity is monitored for six weeks after the first treatment dose, and dosing intervals may be adjusted as agreed by the study team. During the study, participants will have imaging scans, safety evaluations, and laboratory tests to track the distribution and effects of 177Lu-RAD204. Researchers will measure pharmacokinetics, radiation dosimetry, and tumor responses up to 30 weeks. Safety and tolerability are closely monitored throughout. Participants must meet specific health and tumor criteria to join and will be observed for any adverse reactions. The total duration of participation varies depending on treatment response and tolerability.
CONDITIONS
Brief Title
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent and comply with study procedures
- Adults 18 years of age or older
- Histopathologically confirmed relapsed/refractory locally advanced, inoperable or metastatic NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or cancers with MMR deficiency or MSI high with disease progression after recent anticancer therapy
- PD-L1 positive tumors or willingness to undergo PD-L1 testing if status is unknown
- At least one measurable target lesion per RECIST 1.1
- ECOG performance status 0 to 2
- Life expectancy of at least 4 months as per Investigator
- Women of childbearing potential must have negative pregnancy test and not be breastfeeding
- Women of childbearing potential and male participants must agree to use highly effective contraception during and after the study as specified
- Participants with treated, stable brain metastases meeting specified neurological and radiological criteria
- For Phase I, positive lesion(s) by 177Lu-RAD204im SPECT/CT or case-by-case enrollment if tumor is known PD-L1 positive
You will not qualify if you...
- History of prior organ transplant
- Any other active malignancy except treated cervical intraepithelial neoplasia or non-melanoma skin cancer
- Medical conditions preventing full participation such as severe claustrophobia or inability to lie still for imaging
- Residual toxicity Grade 2 or higher from prior therapies (except alopecia)
- History of uncontrolled allergic reactions or hypersensitivity to protein therapeutics or 177Lu-RAD204
- Inadequate organ function based on specified laboratory parameters
- Blood transfusion within 4 weeks before first treatment dose
- Significant cardiovascular disease including unstable angina, recent heart attack, heart failure, abnormal ECG findings, uncontrolled hypertension, low heart function, or long QT syndrome
- Participation in another investigational trial at consent
- Pregnant or lactating women
- Recent anti-cancer therapy within 28 days before first treatment dose
- Prior treatment with certain immune checkpoint inhibitors with severe immune-related adverse effects
- Major surgery less than 28 days before first treatment dose unless approved
- Positive HIV status
- Active or chronic hepatitis B or C unless stable on suppression therapy
- Any condition posing high risk for toxicity or uncontrolled illness including active infections requiring systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 weeks
Participants receive a low dose of 177Lu-RAD204 for imaging to assess safety, dosimetry, and image quality.
1 imaging dose visit and follow-up visits over 2 weeks
Duration - Each cycle lasts 6 weeks; multiple cycles possible
Participants receive treatment doses of 177Lu-RAD204 in cycles to determine the recommended dose, with cycles repeated if clinical benefit and safety criteria are met.
Visits at each treatment cycle over 6 weeks with additional visits as needed for safety and dosimetry monitoring
Trial Site Locations
Total: 5 locations
1
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Actively Recruiting
2
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
3
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
4
Cancer Research SA (CRSA)
Adelaide, South Australia, Australia, 5000
Actively Recruiting
5
GenesisCare Murdoch
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
Research Team
D
Dimitris Voliotis, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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