Prostate CancerPhase 1/2NCT07363486
Sequential Study of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
A Phase 1/2 study testing 225Ac-LNC1011 in people with Prostate Cancer, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 225Ac-LNC1011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic Castration-Resistant Prostate Cancer (mCRPC) mCRPC refers to prostate cancer that progresses despite serum testosterone at castrate levels (< 50 ng/dL or 1.7 nmol/L), meeting at least one of the following criteria:
- PSA >1 ng/mL with two consecutive rises at least 1 week apart, each increase ≥50% above the nadir.
- Radiographic progression: Either two or more new bone lesions on bone scan, or soft tissue lesion progression as per RECIST 1.1 criteria. Progression based on symptoms alone is insufficient for mCRPC diagnosis and requires further evaluation.
- Failure of, Refusal of, Absence of, or Refractoriness to Standard Therapy, or Disease Progression, or No Available Standard Therapy per Current Guidelines:
- Patients who have not received, refused, or progressed after receiving at least 1 but no more than 2 prior taxane-based therapies. The taxane regimen must have included exposure for at least 2 cycles. Patients who received only one taxane may be included if the investigator deems them unsuitable for a second taxane (e.g., due to frailty assessed by geriatric/comorbidity evaluation or intolerance).
- Patients who have progressed after receiving at least one novel androgen axis drug [NAAD] (e.g., abiraterone, enzalutamide).
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- Ability to understand and voluntarily sign a written informed consent form (ICF), and willingness and ability to comply with trial procedures including examinations and follow-up.
- Age 18-90 years (inclusive).
- Expected survival > 6 months.
- ECOG performance status ≤ 2.
- Presence of high-uptake lesions confirmed by 68Ga-PSMA-11 PET/CT imaging (positive defined as lesion uptake >1.5 times the liver background).
- At least one measurable lesion per RECIST 1.1 criteria OR at least one bone metastasis per PCWG3 criteria.
- Adequate organ function (No blood products, growth factors, or albumin administered within 14 days prior to baseline lab tests):
- Bone Marrow Function: Neutrophil count ≥ 1.5 × 10#/L, White blood cell count ≥ 3.0 × 10#/L, Platelet count ≥ 100 × 10#/L, Hemoglobin ≥ 10 g/dL (≥ 100 g/L).
- Liver Function: Albumin ≥ 30 g/L, Total bilirubin ≤ 1.5 × ULN, ALT or AST ≤ 3.0 × ULN (without liver metastases) or ≤ 5.0 × ULN (with liver metastases).
- Renal Function: Serum creatinine ≤ 1.5 × ULN.
- Coagulation: INR ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 2 × ULN (for patients not on anticoagulation or on stable-dose anticoagulation).
- Agreement to comply with prescribed radiation protection measures during the trial period.
Who cannot join
- Inability to tolerate imaging procedures;
- Patients who have received systemic anticancer therapy (e.g., chemotherapy, radiotherapy, immunotherapy; excluding endocrine therapy), investigational drugs, or device therapy within 4 weeks prior to dosing;
- Patients who received radionuclide therapy (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Lutetium-177) within 6 months, or any External Beam Radiation Therapy (EBRT) within 2 months prior to the first dose;
- Patients with unresolved Grade 4 myelosuppression from prior anticancer therapy within 2 weeks, or Grade 3 myelosuppression requiring >6 weeks for recovery;
- Planned use of cytotoxic chemotherapy, antitumor immunotherapy, radioligand therapy, or similar agents during the study;
- Use of blood products or albumin within 14 days before dosing to meet enrollment criteria;
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- Brain metastasis at screening, except:
- Asymptomatic cases confined to supratentorial/cerebellar regions (no midbrain/pons/medulla/spinal cord involvement) without corticosteroid therapy and with lesions ≤1.5 cm;
- Symptomatic cases with treated and radiologically stable lesions (>4 weeks);
- Other malignancies within 5 years (excluding cured localized cancers like basal/squamous cell skin carcinoma);
- Superscan on bone scintigraphy;
- Symptomatic or impending spinal cord compression;
- Prior EBRT involving extensive bone marrow (>25%);
- Significant cardiac disease at screening, including:
- QTcF >470 ms or long QT syndrome history;
- Myocardial infarction, angina, or CABG within 6 months deemed ineligible by investigators;
- Any condition that, per investigator judgment, may compromise safety, data interpretation, or indicate high risk;
- Uncontrolled bladder outlet obstruction, urinary incontinence, claustrophobia, or radiophobia at screening;
- Positive for HCV-Ab, HIV, or syphilis antibodies at screening;
- HBsAg-positive patients with active HBV replication (confirmed by HBVDNA per investigator assessment);
- Known allergy to proteins/peptides, excipients, or structurally related compounds;
- History of drug/alcohol abuse within 1 year or chronic substance abuse;
- Failure to use effective contraception during the trial and for 6 months post-last dose;
- Severe active infection prior to the first administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Guochang Wang, MD, +86-0591 87981619, guochang1007@163.com
Jie Zang, MD, +86-0591 87981619, 15901495106@163.com
About this study
Official title: Prospective Sequential Study of Dose-Escalating 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
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.
Read the detailed description
Prostate-specific membrane antigen (PSMA)-targeted radioligand therapy has demonstrated considerable potential in the treatment of metastatic castration-resistant prostate cancer (mCRPC). By incorporating albumin-binding motifs into PSMA radioligands, the circulation time in the bloodstream can be prolonged, leading to significantly enhanced tumor uptake and therapeutic efficacy. LNC1011 employs dansylated Amino Acid as a novel, relatively weak yet high-performance albumin-binding moiety, achieving an optimal balance among increased tumor accumulation, improved safety, and refined diagnostic performance. This enables a unified theranostic approach within a single molecular framework.
Alpha-emitting radionuclides, represented by Ac-225, generate alpha particles during decay. Their linear energy transfer is nearly 100-fold higher than that of β-emitters such as Lu-177, resulting in significantly enhanced tumor cell kill. This has earned them the designation of "scalpel-like radiotherapy." Moreover, alpha particles have an extremely short range (only a few cell diameters), causing minimal damage to surrounding normal tissues and almost no notable side effects, thereby conferring an excellent safety profile.
In this clinical study, we will follow a "3+3" trial design to evaluate the safety and efficacy of different doses of 225Ac-LNC1011 in patients with mCRPC. The initial dose of 225Ac-LNC1011 is set at 3.70 MBq (100 μCi). Approximately three subjects will be enrolled at the current dose level. If no dose-limiting toxicity (DLT) is observed, the next cohort will receive an escalated dose of 5.55 MBq (150 μCi). If again no DLT occurs, the subsequent cohort will be escalated to 7.40 MBq (200 μCi), which is the planned maximum dose. It should be noted that if one DLT occurs at any dose level, three additional patients will be enrolled at the same dose. If only one DLT is observed among the total of six subjects, dose escalation may proceed. If two or more DLTs occur, dose de-escalation or trial termination will be initiated. Subjects in all dose cohorts will receive up to four treatment cycles at 8- to 12-week intervals. All participants will undergo safety follow-up during the trial and for 12 months after its completion.
- Conditions
- Prostate Cancer
- Being tested
- 225Ac-LNC1011
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
225Ac-LNC1011Drug
administered intravenously once every 8-12 weeks (1 cycle) for up to 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| 3.70 MBq (100 μCi) 225Ac-LNC1011 dose cohort | Experimental | Participant will receive 3.70 MBq (+/- 10%) 225Ac-LNC1011, once every 8-12 weeks for up to 4 cycles Receives: Drug: 225Ac-LNC1011 |
| 5.55 MBq (150 μCi) 225Ac-LNC1011 dose cohort | Experimental | Participant will receive 5.55 MBq (+/- 10%) 225Ac-LNC1011, once every 8-12 weeks for up to 4 cycles Receives: Drug: 225Ac-LNC1011 |
| 7.40 MBq (200 μCi) 225Ac-LNC1011 dose cohort | Experimental | Participant will receive 7.40 MBq (+/- 10%) 225Ac-LNC1011, once every 8-12 weeks for up to 4 cycles Receives: Drug: 225Ac-LNC1011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment Emergent Adverse Events
The distribution of adverse events (AE) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Measured: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)
Prostate-specific antigen 50 (PSA50) response
PSA50 response is defined as the proportion of patients who have a more/equal 50% decrease in PSA from baseline, it will be calculated at 12, 24 and 48 months
Measured: From date of randomization till 30 days safety fup, assessed up to 50 months (estimated final OS analysis)
Secondary outcomes (1)
Progression Free Survival (PFS)
PSA-PFS is defined as the time from date of enrollment to the date of first documented progression by investigator assessment (radiographic progression, clinical progression, PSA progression) or death from any cause, whichever occurs first
Measured: From date of enrollment until date of progression or date of death from any cause, whichever come first, assessed up to 50 months (estimated final OS analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Miao, MD, Study chair, Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363486
- Sponsor's protocol ID
- Sequential Study-225Ac-LNC1011
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Sequential Study of Dose-Escalating 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07363486
- Acronym / sponsor ID
- Sequential Study-225Ac-LNC1011
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prostate-specific membrane antigen (PSMA)-targeted radioligand therapy has demonstrated considerable potential in the treatment of metastatic castration-resistant prostate cancer (mCRPC). By incorporating albumin-binding motifs into PSMA radioligands, the circulation time in the bloodstream can be prolonged, leading to significantly enhanced tumor uptake and therapeutic efficacy. LNC1011 employs dansylated Amino Acid as a novel, relatively weak yet high-performance albumin-binding moiety, achieving an optimal balance among increased tumor accumulation, improved safety, and refined diagnostic performance. This enables a unified theranostic approach within a single molecular framework.
Alpha-emitting radionuclides, represented by Ac-225, generate alpha particles during decay. Their linear energy transfer is nearly 100-fold higher than that of β-emitters such as Lu-177, resulting in significantly enhanced tumor cell kill. This has earned them the designation of "scalpel-like radiotherapy." Moreover, alpha particles have an extremely short range (only a few cell diameters), causing minimal damage to surrounding normal tissues and almost no notable side effects, thereby conferring an excellent safety profile.
In this clinical study, we will follow a "3+3" trial design to evaluate the safety and efficacy of different doses of 225Ac-LNC1011 in patients with mCRPC. The initial dose of 225Ac-LNC1011 is set at 3.70 MBq (100 μCi). Approximately three subjects will be enrolled at the current dose level. If no dose-limiting toxicity (DLT) is observed, the next cohort will receive an escalated dose of 5.55 MBq (150 μCi). If again no DLT occurs, the subsequent cohort will be escalated to 7.40 MBq (200 μCi), which is the planned maximum dose. It should be noted that if one DLT occurs at any dose level, three additional patients will be enrolled at the same dose. If only one DLT is observed among the total of six subjects, dose escalation may proceed. If two or more DLTs occur, dose de-escalation or trial termination will be initiated. Subjects in all dose cohorts will receive up to four treatment cycles at 8- to 12-week intervals. All participants will undergo safety follow-up during the trial and for 12 months after its completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3.70 MBq (100 μCi) 225Ac-LNC1011 dose cohort | Experimental | Drug: 225Ac-LNC1011Participant will receive 3.70 MBq (+/- 10%) 225Ac-LNC1011, once every 8-12 weeks for up to 4 cycles |
| 5.55 MBq (150 μCi) 225Ac-LNC1011 dose cohort | Experimental | Drug: 225Ac-LNC1011Participant will receive 5.55 MBq (+/- 10%) 225Ac-LNC1011, once every 8-12 weeks for up to 4 cycles |
| 7.40 MBq (200 μCi) 225Ac-LNC1011 dose cohort | Experimental | Drug: 225Ac-LNC1011Participant will receive 7.40 MBq (+/- 10%) 225Ac-LNC1011, once every 8-12 weeks for up to 4 cycles |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Metastatic Castration-Resistant Prostate Cancer (mCRPC) mCRPC refers to prostate cancer that progresses despite serum testosterone at castrate levels (< 50 ng/dL or 1.7 nmol/L), meeting at least one of the following criteria:
- Failure of, Refusal of, Absence of, or Refractoriness to Standard Therapy, or Disease Progression, or No Available Standard Therapy per Current Guidelines:
- Ability to understand and voluntarily sign a written informed consent form (ICF), and willingness and ability to comply with trial procedures including examinations and follow-up.
- Age 18-90 years (inclusive).
- Expected survival > 6 months.
Key exclusion criteria (24 listed)
- Inability to tolerate imaging procedures;
- Patients who have received systemic anticancer therapy (e.g., chemotherapy, radiotherapy, immunotherapy; excluding endocrine therapy), investigational drugs, or device therapy within 4 weeks prior to dosing;
- Patients who received radionuclide therapy (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Lutetium-177) within 6 months, or any External Beam Radiation Therapy (EBRT) within 2 months prior to the first dose;
- Patients with unresolved Grade 4 myelosuppression from prior anticancer therapy within 2 weeks, or Grade 3 myelosuppression requiring >6 weeks for recovery;
- Planned use of cytotoxic chemotherapy, antitumor immunotherapy, radioligand therapy, or similar agents during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 225Ac-LNC1011administered intravenously once every 8-12 weeks (1 cycle) for up to 4 cycles | Drug | 3.70 MBq (100 μCi) 225Ac-LNC1011 dose cohort, 5.55 MBq (150 μCi) 225Ac-LNC1011 dose cohort, 7.40 MBq (200 μCi) 225Ac-LNC1011 dose cohort |
Primary outcome
Number of participants with Treatment Emergent Adverse Events
Time frame: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)
The distribution of adverse events (AE) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Prostate-specific antigen 50 (PSA50) response
Time frame: From date of randomization till 30 days safety fup, assessed up to 50 months (estimated final OS analysis)
PSA50 response is defined as the proportion of patients who have a more/equal 50% decrease in PSA from baseline, it will be calculated at 12, 24 and 48 months
1 secondary outcome
Progression Free Survival (PFS)
Time frame: From date of enrollment until date of progression or date of death from any cause, whichever come first, assessed up to 50 months (estimated final OS analysis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weibing Miao, MD study chair
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 225Ac-LNC1011 in people with Prostate Cancer, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weibing Miao, MD (+86-0591-87981618, miaoweibing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment Emergent Adverse Events (time frame: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.