Actively Recruiting
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
Led by Radiopharm Theranostics, Ltd · Updated on 2026-02-19
30
Participants Needed
5
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 aged 18 years or older
- Diagnosed with relapsed/refractory locally advanced, inoperable, or metastatic NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer, or cancers known to be MMR deficient or MSI high with disease progression after recent therapy
- Tumor positive for PD-L1 or willing to undergo PD-L1 testing if unknown
- At least one measurable target lesion by RECIST 1.1
- ECOG performance status 2 or less
- Life expectancy of 4 months or more
- Women of childbearing potential must have negative pregnancy test, not be breastfeeding, and agree to use effective contraception
- Male participants able to father a child must agree to use effective contraception and not donate sperm during and following specified periods after treatment
- Participants with treated, stable brain metastases meeting specific neurological and imaging criteria
- For Phase I, presence of positive lesion(s) by 177Lu-RAD204im SPECT/CT or known PD-L1 expression for enrollment
You will not qualify if you...
- History of prior organ transplant
- Presence of any active malignancy other than treated cervical intraepithelial neoplasia or non-melanoma skin cancer, with some exceptions
- Medical conditions preventing safe participation, including severe claustrophobia or inability to lie still for imaging
- Residual toxicity grade 2 or higher from prior cancer therapy (except hair loss)
- History of severe allergic reactions or hypersensitivity to protein therapeutics or study drug components
- Inadequate organ function based on specific laboratory values (kidney, blood counts, liver enzymes, coagulation)
- Need for blood transfusion within 4 weeks before treatment
- Significant cardiovascular disease including recent heart attack, heart failure, rhythm abnormalities, uncontrolled hypertension, low heart function, or prolonged QT interval
- Participation in other investigational trials at consent
- Pregnant or breastfeeding women
- For Phase I, recent anti-cancer therapy within 28 days before treatment
- Prior severe immune-related adverse events from similar immunotherapies
- Recent major surgery within 28 days before treatment
- Positive HIV status
- Active or chronic hepatitis B or C unless stable on treatment
- Any condition posing high risk for toxicity or uncontrolled illness requiring systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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