OncoMatch/Clinical Trials/NCT06305962
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
Is NCT06305962 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies 177Lu-RAD204 for pdl1 gene mutation.
Treatment: 177Lu-RAD204 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Triple-Negative Breast Cancer
Breast Carcinoma
Melanoma
Head and Neck Squamous Cell Carcinoma
Endometrial Cancer
Biomarker criteria
Required: PD-L1 (CD274) positive expression (PD-L1 positive)
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
Required: MMR deficient
any cancer that is known to be MMR deficient
Required: MSI high
any cancer that is known to be MSI high
Required: PD-L1 (CD274) imaging positive lesion
Participants must have positive lesion(s) by 177Lu-RAD204im SPECT/CT per central review
Disease stage
Metastatic disease required
relapsed/refractory locally advanced, inoperable or metastatic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anticancer therapy
documented disease progression during or after their most recent line of anticancer therapy
Cannot have received: blood product transfusion
Patients requiring blood product transfusion within 4 weeks of first dose of 177Lu-RAD204tr are not eligible
Cannot have received: anti-PD-1 therapy
Exception: discontinued due to Grade 3 or higher immune-mediated AE (except controlled endocrine AEs)
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 that treatment due to a Grade 3 or higher immune-mediated AE. NOTE: endocrine immune-mediated AEs that are controlled with replacement therapy are allowed.
Cannot have received: anticancer therapy
Exception: within 28 days (or 5 half-lives for biologic/non-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-RAD204tr (Phase I only)
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 biologic/non-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-RAD204tr.
Lab requirements
Blood counts
Platelet count < 80 × 10^9/L; ANC < 1.5 × 10^9/L; Haemoglobin < 9 g/dL; INR ≥ 1.5 or PT ≥ 1.5 × ULN; PTT or aPTT ≥ 1.5 × ULN
Kidney function
Creatinine clearance or BSA-adjusted eGFR < 60 mL/min
Liver function
ALT or 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
Cardiac function
Unstable angina, acute MI within 6 months, NYHA Class II or greater CHF, significant ECG abnormalities, uncontrolled hypertension, LVEF < 50%, QTcF > 470 msec (females) or > 450 msec (males), congenital long QT syndrome
Inadequate organ functions as reflected in laboratory parameters: Creatinine clearance or BSA-adjusted eGFR < 60 mL/min; Platelet count < 80 × 10^9/L; ANC < 1.5 × 10^9/L; Haemoglobin < 9 g/dL; ALT or 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; INR ≥ 1.5 or PT ≥ 1.5 × ULN; PTT or aPTT ≥ 1.5 × ULN. Cardiac: Unstable angina, acute MI within 6 months, NYHA Class II or greater CHF, significant ECG abnormalities, uncontrolled hypertension, LVEF < 50%, QTcF > 470 msec (females) or > 450 msec (males), congenital long QT syndrome
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify