Actively Recruiting
Sequential Study of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2026-01-23
9
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
PSMA is an ideal target for the precise diagnosis and treatment of prostate cancer. LNC1011 is a novel albumin-binding PSMA-targeted compound. This study aims to investigate the safety and efficacy of different doses of 225Ac-labeled LNC1011 in the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) and to explore the optimal therapeutic dose.
CONDITIONS
Official Title
Sequential Study of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with metastatic castration-resistant prostate cancer (mCRPC) showing progression despite low testosterone levels
- PSA greater than 1 ng/mL with documented rises or radiographic progression with measurable lesions
- Prior treatment failure, refusal, or absence of standard therapy including 1-2 taxane chemotherapies and at least one novel androgen axis drug
- Ability to understand and sign informed consent and comply with trial procedures
- Age between 18 and 90 years inclusive
- Expected survival longer than 6 months
- ECOG performance status of 0 to 2
- Presence of high-uptake lesions on 68Ga-PSMA-11 PET/CT imaging
- At least one measurable lesion per RECIST 1.1 or bone metastasis per PCWG3 criteria
- Adequate bone marrow, liver, renal, and coagulation function
- Agreement to follow radiation protection measures during the trial
You will not qualify if you...
- Inability to tolerate imaging procedures
- Recent systemic anticancer therapy, investigational drugs, or device therapy within 4 weeks prior to dosing
- Radionuclide therapy within 6 months or external beam radiation therapy within 2 months before first dose
- Unresolved severe myelosuppression from prior therapy
- Planned cytotoxic chemotherapy, immunotherapy, or radioligand therapy during the study
- Use of blood products or albumin within 14 days before dosing
- Brain metastases except stable or small asymptomatic lesions without corticosteroids
- Other malignancies within 5 years except cured localized skin cancers
- Superscan on bone scan or symptomatic spinal cord compression
- Prior extensive bone marrow radiation
- Significant cardiac disease including prolonged QTc or recent myocardial events
- Conditions that compromise safety or data interpretation
- Uncontrolled bladder obstruction, incontinence, claustrophobia, or radiophobia
- Positive for HCV, HIV, or syphilis antibodies
- Active hepatitis B virus replication
- Known allergies to proteins or related compounds
- History of drug or alcohol abuse within 1 year
- Failure to use effective contraception during and 6 months after the trial
- Severe active infection before first dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
W
Weibing Miao, MD
CONTACT
G
Guochang Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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