What is 177Lu-RAD204 studying for metastatic solid tumors?

177Lu-RAD204 is being studied to understand its safety, how it spreads in the body, radiation effects, and early anti-tumor activity in patients with PD-L1 positive advanced solid tumors. The study aims to find the best dose for future research. It is sponsored by Radiopharm Theranostics, Ltd.

Who may be eligible for this metastatic solid tumor clinical trial?

Adults aged 18 or older with advanced or metastatic PD-L1 positive cancers such as NSCLC, SCLC, triple-negative breast cancer, melanoma, head and neck cancer, or endometrial cancer may be eligible. Participants must have measurable tumors and meet health criteria. Both males and females can join. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Early Phase 1

Age: 18Years +

All Genders

ID06305962

Phase 01 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

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in a Phase 01 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

Age: 18Years +

All Genders

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

Research Team

Dimitris Voliotis, MD

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