Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients received a single dose of 1.85 GBq (50 mCi) of 177Lu-LNC1011 via intravenous injection, followed by monitoring at 3, 24, 48, 72, and 168 hours post-injection. Subsequent enrollees underwent a 50% incremental dose increase until dose-limiting toxicity was observed.

\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe.

177Lu-LNC1011

Zhaohui Zhu, MD

Jiarou Wang, MD

This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).

\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe. This study represents the first human investigation, aiming to explore its maximum tolerated dose (MTD), safety, dosimetry, and initial treatment efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC).This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).

177Lu-LNC1011 in Patients With Metastatic Castration-resistant Prostate Cancer

Phase 1 Trial Assessing Safety, Maximum Tolerated Dose, and Patient-Specific Dosimetry of [177Lu]Lu-LNC1011 in Metastatic Castration-Resistant Prostate

The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-LNC1011. The dose delivered to normal organs and tumors will be recorded.

Hematologic status were performed before and every 2 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0:Total white cell count less than 2.5 × 10\^9/L,Platelet count less than 75 × 10\^9/L

Liver and renal function were performed before and 4 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0:Progressive deterioration of organ function (GFR \<30 mL/min or creatinine \> 2-fold upper limit of normal (ULN); liver enzymes \> 5-fold ULN).

The serum PSA response was documented semimonthly until 6 weeks after the administration of 177Lu-LNC1011. PSA response was classified as the following: partial response (PR) if PSA decrease ≥50%, progressive disease (PD) if PSA increase ≥ 25% and stable disease (SD) if PSA increase \<25% or PSA decrease \<50%.

Peking Union Medical College Hospital

The patients were intravenously injected with single dose 2.22GBq (60 mCi) of 177Lu-LNC1010 and underwent 68Ga-DOTA-TATE PET/CT scans before and after the treatment.

The patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-LNC1010 and underwent 68Ga-DOTA-TATE PET/CT scans before and after the treatment.

The patients were intravenously injected with single dose 5.18 GBq (140mCi) of 177Lu-LNC1010 and underwent 68Ga-DOTA-TATE PET/CT scans before and after the treatment.

177Lu-LNC1010 1

177Lu-LNC1010 2

The patients were intravenously injected with single dose 5.18GBq (140 mCi) of 177Lu-LNC1010 and underwent 68Ga-DOTA-TATE PET/CT scans before and after the treatment.

177Lu-LNC1010 3

Haojun Chen, PhD

Wei Guo, MD

Haojun Chen, MD, PhD

177Lu-LNC1010(177Lu-EB-TATE-01) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs).

In this study, we designed and developed a new radioligand, EB-TATE-01 (second generation long-acting EB-TATE formula), through combining EB and altering the linker to further improve the pharmacokinetics and pharmacodynamics, leading to substantially enhanced radioligand therapy effect.

This is an open-label, non-controlled, non-randomized study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-LNC1010 in patients with advanced SSTR2-positive tumors. Different groups with doses of 2.22GBq (60 mCi), 3.7GBq (100mCi) and 5.18GBq (140mCi) of 177Lu-LNC1010 will be injected intravenously. All patients will undergo 68Ga-DOTA-Octreotide(TATE) PET/CT scans before and after the treatment.

Somatostatin receptor(SSTR), especially SSTR subtype 2 (SSTR2),has been a popular target for molecular imaging and radionuclide therapy in recent years. SSTR antagonists, such as LNC1010, have emerged as a new type of somatostatin analog, characterized by a low internalization rate and high tumor affinity. 68Ga-DOTA(68Ga-DOTA)-LNC1010 has been reported that it showed favorable biodistribution, high tumor uptake, and good tumor retention, resulting in high image contrast. SSTR2 has been found highly expressed in SSTR2-positive tumors, indicating the feasibility of Positron Emission Tomography（PET)/ CT with 68Ga-DOTA-conjugated peptides for imaging SSTR2 expression and peptide-receptor radionuclide therapy (PRRT) for the treatment option in SSTR2-positive tumors. However, a major problem in the therapeutic use of 177Lu-DOTA(177Lu-DOTA)-LNC1010 has been its short half-life and fast rate of clearance. This study was designed to evaluate the efficacy of a long-lasting radiolabeled somatostatin analogue 177Lu-LNC1010 in patients with SSTR2-positive tumors.

To evaluate response to the different groups with doses of 2.22 GBq(60 mCi) and 3.7 GBq (100 mCi) and 5.18 GBq (140mCi) of 177Lu-LNC1010 in patients with advanced metastatic NPCs.

Evaluatioon of 177Lu-TATE-EB-01（LNC1010）in SSTR2-positive Tumors

A Phase 1, Non-Randomized, Open-Label, Dose Escalation, Single-Center Study to Determine the Safety, Bio-distribution, and Preliminary Effectiveness of 177Lu-TATE-EB-01（LNC1010）in Adult Subjects With SSTR2-positive Tumors

68Ga-Fibroblast activation protein inhibitor 46 and 18F-fluorodeoxyglucose will be performed for efficacy evaluation by RECIST 1.1 and PERCIST. Particularly, 68Ga-FAPI-46 will be performed at baseline and beginning of each circle, and 2 weeks after the last treatment. 18F-FDG will be performed at baseline and 2 weeks after the last treatment.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause.

The First Affiliated Hospital of Xiamen University

All Drugs and Chemicals

Gallium 68 PSMA-11

Radiopharmaceuticals

Escalating doses of 0.75 GBq - 2.0 GBq of CTT1403

Escalating doses of 3.0 GBq - 9.0 GBq of CTT1403

Escalating doses of 0.75 GBq - 9.0 GBq will be administered in an accelerated to traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort. Patients meeting eligibility criteria with demonstrated cessation of disease progression will be offered a second dose of the study drug, CTT1403.

CTT1403

Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.

CTT1057

68Ga-PSMA-11

Beatrice Langton-Webster, PhD

Rahul Aggarwal, MD

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).

This is a Phase 1, first-in-human dose escalation/dose expansion study evaluating escalating doses of CTT1403 in patients with PSMA-avid mCRPC with progressive disease on at least one androgen signaling inhibitor, followed by a dose expansion to further evaluate the safety, tolerability, efficacy and biological activity of CTT1403. CTT1403 is a PSMA-targeted 177Lu-labeled radiotherapy being developed for prostate cancer with a unique PSMA binding scaffold and an albumin binding moiety to extend circulation half-life. The PSMA binding scaffold is shared with CTT1057, a PSMA-specific PET diagnostic imaging agent shown in Phase 1 clinical trials to be specifically taken up by PSMA+ tumor. PSMA PET imaging by CTT1057 will be used diagnostically to select patients with PSMA-avid disease for treatment. The purpose of this study is to identify the dose limiting toxicity and recommended phase 2 dose of CTT1403. Eligible participants with demonstrated therapeutic benefit will be offered a second dose of study drug.

Prostate cancer is a disease only occurring in males.

A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

A Phase 1 Trial for Evaluation of Safety and 177Lu Radiation Dosimetry of CTT1403: A Peptidomimetic Inhibitor of Prostate Specific Membrane Antigen, in Metastatic Castration Resistant Prostate Cancer (mCRPC)

The dose-limiting toxicity was defined as any of the following:

1. Grade 4 neutropenia lasting \> 5 consecutive days
2. Grade 3 or 4 febrile neutropenia
3. Grade 4 thrombocytopenia lasting ≥ 7 days, or Grade 3 or 4 thrombocytopenia with clinically significant bleeding or requirement for platelet transfusion
4. Any nonhematologic, treatment-related AE ≥ Grade 3, with the exceptions of Grade 3 nausea, vomiting, diarrhea, non-clinically significant electrolyte abnormality, constipation, fever, fatigue, or skin rash that resolves to Grade ≤ 2 within 72 hours with optimal medical management
5. Any other treatment-related toxicity that results in delay of Cycle 2 administration of CTT1403 by \> 21 days and/or toxicity considered by the Investigator and Sponsor's medical representatives to be dose-limiting.

Changes in only the largest diameters (unidimensional measurment) of the tumor lesions are used in the RECIST v1.1 criteria. Data presented as RECIST Overall Response.

Organ dosimetry was assessed via SPECT/CT imaging until two imaging periods have been collected in which study drug cannot be detected by SPECT/CT. Time points included (2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1. Data calculated using OLINDA. Absorbed dose is calculated as single value wherein absorbed dose is proportional to the integral of activity over time.

The Brief Pain Index uses a scale of 0-10 to rate the severity of pain. A rating of 0 indicates no pain. A rating of 10 indicates the worst pain imaginable.

The distribution half-life and the elimination half-life of CTT1403 were calculated.

University of California, San Francisco

National Cancer Institute (NCI)

Cancer Targeted Technology

0.75 GBq Cohort

1.5 GBq Cohort

2.0 GBq Cohort

3.0 GBq Cohort

4.5 GBq Cohort

6.0 GBq Cohort

7.5 GBq Cohort

9.0 GBq Cohort

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The highest administered dose of CTT1403 was 9.0 GBq. At the 9.0 GBq dose, patients had to remain in-patient (in hospital) after administration due to continued radioactivity and for the safety of others until radioactivity dropped to an acceptable level as deemed by the hospital radiation safety committee.

Dr. Beatrice Langton-Webster, CEO

Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403

Number of patients with stable disease on Cycle 1-Day 35

Number of patients with progressive disease on Cycle 1-Day 35

Number of patients with stable disease on Cycle 2-Day 35

Number of patients with progressive disease on Cycle 2-Day 35

Number of patients with stable disease 30 days after last dose

Number of patients with progressive disease 30 days after last dose

Number of patients with stable disease 8 weeks post-treatment

Number of patients with progressive disease 8 weeks post-treatment

In cases where the number analyzed differs from the total number in the group, data was either not available, patient was lost to follow-up, or patient withdrew.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
177Lu-LNC1011 in Patients With Metastatic Castration-resistant Prostate Cancer	NCT06250244	Metastatic Cast...	177Lu-LNC1011	18 Years - 80 Years	Peking Union Medical College Hospital
177Lu-LNC1011 in Patients With Metastatic Castration-resistant Prostate Cancer	NCT06250244	Metastatic Cast...	177Lu-LNC1011	18 Years - 80 Years	Peking Union Medical College Hospital
Evaluatioon of 177Lu-TATE-EB-01（LNC1010）in SSTR2-positive Tumors	NCT05410743	SSTR2-positive ...	177Lu-LNC1010 1 177Lu-LNC1010 2 177Lu-LNC1010 3	18 Years - 70 Years	The First Affiliated Hospital of Xiamen University
Evaluatioon of 177Lu-TATE-EB-01（LNC1010）in SSTR2-positive Tumors	NCT05410743	SSTR2-positive ...	177Lu-LNC1010 1 177Lu-LNC1010 2 177Lu-LNC1010 3	18 Years - 70 Years	The First Affiliated Hospital of Xiamen University
A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer	NCT03822871	Prostate Cancer	CTT1403 CTT1057 68Ga-PSMA-11	18 Years -	Cancer Targeted Technology

Spots Global Cancer Trial Database for 177lu

Every month we try and update this database with for 177lu cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 177lu

Every month we try and update this database with for 177lu cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 177lu cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.