[177Lu]ludotadipep (177 Lu-FC705) / FutureChem - LARVOL DELTA

Multi cycle dosimetry of the albumin binding PSMA ligand [177Lu]Ludotadipep in metastatic castration resistant prostate cancer: Phase II trial results (ESMO 2025) - P2 | "Conclusions Up to six cycles of [ 177 Lu]Ludotadipep can be administered safely with organ doses comparable to those reported for [ 177 Lu]Lu-PSMA-617. Employing hematocrit or SPECT/CT-adjusted RMBLR could improve the red-marrow dosimetry and support individualized treatment planning for albumin-conjugated PSMA radiopharmaceuticals."

Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ESMO 2025: Multi Cycle Dosimetry of the Albumin Binding PSMA Ligand [¹⁷⁷Lu]Ludotadipep in Metastatic Castration Resistant Prostate Cancer: Phase II Trial Results (Urology Times) - "The hematocrit-adjusted red marrow-to-blood activity ratio (0.28 ± 0.01) was consistent with SPECT/CT-derived values, reinforcing the accuracy of this dosimetric model for albumin-bound radiopharmaceuticals...The investigators reported that the salivary glands and kidneys exhibited the highest absorbed-dose coefficients during the first treatment cycle (1.22 ± 0.53 Gy·GBq⁻¹ and 0.67 ± 0.33 Gy·GBq⁻¹, respectively), while red marrow exposure remained low (0.053 ± 0.012 Gy·GBq⁻¹). With subsequent cycles, salivary gland doses significantly decreased (p < 0.001), likely reflecting radiation-induced changes within glandular tissue. Importantly, cumulative organ doses over six treatment cycles stayed within accepted safety limits 8.13 Gy for kidneys and 1.28 Gy for red marrow..."

P2 data • Castration-Resistant Prostate Cancer

The company said Tuesday that part of the phase 2 trial results for FC705...has been accepted for poster presentation at the European Society for Medical Oncology (ESMO 2025) conference, to be held in Berlin, Germany, from Wednesday to Sunday. (Korea Biomedical Review) - "FutureChem also said it is preparing an application for conditional approval of FC705 in Korea."

P2 data • Castration-Resistant Prostate Cancer

FutureChem said on Monday that it has received approval from the Ministry of Food and Drug Safety (MFDS) for its phase 3 clinical trial plan of the prostate cancer radiopharmaceutical FC705 in Korea. (Korea Biomedical Review) - "The trial will target patients with metastatic castration-resistant prostate cancer (mCRPC). It is a randomized clinical study comparing a standard of care (SoC)/best supportive care (BSC) monotherapy group with a group receiving combination therapy with FC705. A total of 114 patients will be enrolled across eight medical institutions in the Seoul metropolitan area, including the Catholic University of Korea Seoul St. Mary’s Hospital."

New P3 trial • Castration-Resistant Prostate Cancer

FutureChem Announces Final Results of Phase 2 Clinical Trial of FC705 for Prostate Cancer Treatment (Pharm News) - P2 | N=20 | LUCIDA_2 (NCT05579184) | Sponsor: FutureChem | "FutureChem...announced on the 8th that it had received the final results report for the phase 2 clinical trial of FC705, a radiopharmaceutical candidate for prostate cancer treatment....The average number of administrations was confirmed to be 3.4 times, and the average dose per administration was 100 mci, which is half that of competitive drugs, but the number of patients whose PSA, which is used as a blood biomarker for prostate cancer treatment evaluation, decreased by more than 50% was up to 73.3% (Best PSA-PR standard). In addition, the objective response rate (ORR) and disease control rate (DCR), which are the most widely used efficacy indicators in phase 2 clinical trials of anticancer drugs, were 60% and 93.3%, respectively."

P2 data • Castration-Resistant Prostate Cancer

FutureChem moves new prostate cancer drug into phase 3 trial in Korea (Korea Biomedical Review) - "FutureChem is pushing ahead with its prostate cancer radiopharmaceutical FC705, moving the candidate into a phase 3 trial in Korea to assess its potential in metastatic castration-resistant prostate cancer (mCRPC). The study, set to enroll 94 patients, will be conducted at eight hospitals in the Seoul metropolitan area, including Seoul St. Mary’s Hospital. FutureChem is testing FC705 in combination with standard therapy, comparing its efficacy and safety to standard treatment alone."

New P3 trial • Castration-Resistant Prostate Cancer

FutureChem presents phase 2 results for prostate cancer drug at APPS Conference (Korea Biomedical Review) - P2 | N=20 | LUCIDA_2 (NCT05579184) | Sponsor: FutureChem | "As a result, despite FC705 being administered alone, the treatment achieved a PSA reduction rate of over 50 percent, surpassing other radiopharmaceuticals with the same mechanism of action. Of the total 11 patients experiencing adverse events, most effects were mild to moderate. Specifically, three patients experienced Grade 1 events, three had Grade 2 events, and five reported Grade 3 events, with no cases of Grade 4 or 5 adverse events reported."

P2 data • Metastatic Castration-Resistant Prostate Cancer

FutureChem, FC705 Phase 2 Interim Data Oral Presentation at European Society of Nuclear Medicine [Google translation] (Hankyung) - "FutureChem aims to complete the clinical trial report (CSR) within the first quarter of 2025 and enter domestic Phase 3 clinical trials and apply for early product approval within the first half of next year. Patient enrollment for the US Phase 2a clinical trial of FC705 is currently approximately 50% complete and is expected to be 100% completed by the first quarter of next year."

Approval • New P3 trial • Trial status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

FutureChem, FC705 Phase 2 Interim Data Oral Presentation at European Society of Nuclear Medicine [Google translation] (Hankyung) - P2 | N=20 | LUCIDA_2 (NCT05579184) | Sponsor: FutureChem | "This announcement is the interim result of the phase 2 clinical trial of FC705 currently underway in Korea. The safety and efficacy were evaluated by administering 100 mCi of FC705 up to 6 times at 8-week intervals to patients with metastatic castration-resistant prostate cancer...'The average number of administrations per registered patient in this domestic phase 2 clinical trial was 3.4 times, and the number of patients whose PSA, a key indicator of cancer treatment, decreased by more than 50% was 13, which is one more patient than the patient announced in the abstract of the paper last month.'...'Complete remission (CR) is defined as a decrease in PSA to 0.2 ng/mL or less, and this result was confirmed in a total of 3 patients, and an additional 1 patient showed a treatment effect close to CR.'....'regarding adverse reactions, Grade 3 or higher adverse reactions (SAEs) were observed...'"

P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Results of phase 2 study of [177Lu]Ludotadipep for metastatic castration-resistant prostate cancer (EANM 2024) - P2 | "Interim results signal that multiple cycles of 3.7 GBq [177Lu] Ludotadipep could be an effective radiopharmaceutical for RLT in mCRPC patients of Korean ethnicity."

Metastases • P2 data • Genito-urinary Cancer • Hematological Disorders • Infectious Disease • Metastatic Castration-Resistant Prostate Cancer • Musculoskeletal Diseases • Oncology • Prostate Cancer • Septic Shock • Solid Tumor • Thrombocytopenia

FutureChem's FC-705 receives orphan drug designation for prostate cancer treatment (Korea Biomedical Review) - "FutureChem, a Korean radiopharmaceutical company, said on Tuesday that FC-705, the company's prostate cancer treatment, has received orphan drug designation from the Ministry of Food and Drug Safety (MFDS)....As a result of this designation, FC-705 will benefit from the government support and fee reductions for its approval process....FutureChem also said that initial phase 1 trials demonstrated 'superior therapeutic efficacy at half the dose of competitors.' Currently, FC-705 is advancing through phase 2 clinical trials in Korea and phase 2a trials in the United States....Meanwhile, phase 2 clinical trials in Korea have seen significant progress: 90 percent of patients have completed repeat dosing, and total patient dosing is expected to conclude by October this year."

Orphan drug • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Korean prostate cancer radiopharmaceutical dosed 1st US patient in P2 trial (Korea Biomedical Review) - "FutureChem said Monday that it has recently entered full-scale clinical trials with the first dose of its radiopharmaceutical, FC705, in patients with metastatic castration-resistant prostate cancer (mCRPC) in a U.S. phase 2a study....The U.S. clinical trial of FC705 was conducted at five centers, including the University of Maryland Medical Center....In the U.S. phase 2a study, the 100 mCi dose will be repeated in 20 patients, evaluating the safety and efficacy of the drug in patients with castration-resistant metastatic prostate cancer."

Trial status • Metastatic Castration-Resistant Prostate Cancer

LUCIDA_2: [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2 (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: FutureChem | Recruiting ➔ Active, not recruiting | Trial completion date: May 2024 ➔ Dec 2024 | Trial primary completion date: Mar 2024 ➔ Dec 2024

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

LUCIDA: [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application (clinicaltrials.gov) - P1/2 | N=26 | Recruiting | Sponsor: FutureChem | Phase classification: P2a ➔ P1/2 | Trial completion date: Aug 2024 ➔ Jun 2025 | Trial primary completion date: Aug 2024 ➔ Jun 2025

Metastases • Phase classification • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Dosimetric Analysis of a Phase I Study of PSMA-Targeting Radiopharmaceutical Therapy With [Lu]Ludotadipep in Patients With Metastatic Castration-Resistant Prostate Cancer. (PubMed, Korean J Radiol) - "[Lu]Ludotadipep is expected to be safe at the dose of 3.7 GBq times 6 cycles planned for a phase II clinical trial with kidneys and bone marrow being the critical organs, and shows a high tumor absorbed dose."

Journal • Metastases • P1 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Janssen’s ’JNJ-42756493’ remains the most administered to cancer patients without a cure [Google translation] (News The Voice Healthcare) - "Although no medicines have been approved in the past three quarters, how many medicines have been administered to treat patients under the judgment of medical staff? According to the Ministry of Food and Drug Safety's approval status for therapeutic purposes in the third quarter...In addition, 2 cases of ‘[177Lu]ludotadipep , [F-18]florastamine’ in patients with castration-resistant prostate cancer, 2 cases of ‘Ac-225-DOTATATE’ in patients with neuroendocrine tumors, and 2 cases each of metastatic breast cancer and oropharyngeal cancer."

Commercial • Breast Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Oropharyngeal Cancer • Prostate Cancer • Solid Tumor

FutureChem receives final results report of US phase 1 clinical trial for prostate cancer treatment [Google translation] (Money Today) - P1 | N=30 | NCT04509557 | Sponsor: FutureChem | "FutureChem...announced on the 6th that 'FC705', a radiopharmaceutical being developed as a treatment for prostate cancer, has received the final results report of the US phase 1 clinical trial....As a result of phase 1 clinical trials, the level of PSA (prostate-specific antigen), an indicator of prostate cancer treatment, decreased in all patients who participated in the clinical trial. Half of the patients participating in the clinical trial had a decrease in PSA of more than 50%, which is the same as the results of the domestic phase 1 clinical trial. Among these, 88% of patients showed the highest PSA decline rate. No dose-limiting toxicity (DLT) was identified in the safety evaluation, and only minor adverse reactions were observed."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Evaluation of PSMA target diagnostic PET tracers for therapeutic monitoring of [Lu]ludotadipep of prostate cancer: Screening of PSMA target efficiency and biodistribution using [F]DCFPyL and [Ga]PSMA-11. (PubMed, Biochem Biophys Res Commun) - "All three agents showed high uptake in tumor tissue on autoradiography, and PSMA expression was confirmed by immunohistochemistry. Thus, [F]DCFPyL or [Ga]PSMA-11 can be used as a PET imaging agent to monitor [Lu]ludotadipep therapy in prostate cancer patients."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

LUCIDA: [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application (clinicaltrials.gov) - P2a | N=26 | Recruiting | Sponsor: FutureChem | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

LUCIDA_2: [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2 (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: FutureChem | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Monrol and FutureChem Announced a Clinical Supply Partnership (Businesswire) - "Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) is delighted to announce that it has reached an agreement in principal with FutureChem based in Seoul, South Korea, a radiopharmaceutical company, for the clinical supply of radioisotope, Lu-177 n.c.a. (Lutetium-177 non-carrier-added), to support FutureChem’s Investigational New Drug IND-enabling Phase 2 clinical trial with Ludotadipep, 177Lu-FC705 to assess the efficacy and safety for repeated administration of the recommended Ludotadipep dose in patients with metastatic castration resistant prostate cancer (mCRPC). Clinical supply contract signed by two parties on 18th of Oct 2022 in Barcelona. A new supply contract between Monrol and FutureChem will be signed following the commercialization of the product in South Korea and US."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

[177Lu]Ludotadipep Treatment in Patients With Metastatic Castration-resistant Prostate Cancer. (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: FutureChem | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jun 2022 | Trial primary completion date: Dec 2022 ➔ Jun 2022

Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

LUCIDA_2: [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2 (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: FutureChem

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

LUCIDA: [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application (clinicaltrials.gov) - P2a | N=26 | Not yet recruiting | Sponsor: FutureChem

New P2a trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor