225Ac-FL-020 / Full-Life Technologies Limited - LARVOL DELTA

ProTACT: A first-in-human, Phase 1 study evaluating the safety, tolerability, and anti-tumor activity of [225Ac]Ac-FL-020, a PSMA-targeted radioconjugate in patients with mCRPC – Dose escalation results (ESMO 2026) - No abstract available

Clinical • First-in-human • P1 data • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

ProTACT: A first-in-human, phase 1 study evaluating the safety, tolerability, and anti-tumor activity of 225Ac]Ac-FL-020, an anti-PSMA radioconjugate in patients with mCRPC. (ASCO-GU 2026) - P1 | "These initial findings support the feasibility and tolerability of [225Ac]Ac-FL-020 administration in heavily pretreated patients with mCRPC. The MTD has not yet been reached, and dose escalation continues. Further safety and efficacy data will be shared as enrollment progresses."

Clinical • First-in-human • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer

ProTACT: A first-in-human, phase 1 dose escalation and expansion study evaluating the safety, tolerability, and anti-tumor activity of [225Ac]Ac-FL-020, a PSMA-targeted radioconjugate, in patients with mCRPC. (ASCO 2026) - P1 | "Secondary endpoints include overall response rate, disease control rate, radiological progression-free survival, and pharmacokinetic parameters (eg, maximum plasma concentration). The study is active in Australia, the United States, Turkey, and China."

Clinical • First-in-human • P1 data • Castration-Resistant Prostate Cancer • Dental Disorders • Oncology • Prostate Cancer • Xerostomia

ProTACT: Preliminary data from a first-in-human, phase 1 study evaluating the safety, tolerability, and anti-tumor activity of [225Ac]Ac-FL-020, a PSMA-targeted radioconjugate, in patients with mCRPC. (ASCO 2026) - P1 | "These initial findings support the feasibility and tolerability of [225Ac]Ac-FL-020 administration in heavily pretreated pts with mCRPC with a few notable PSA responses. The RP2D has not yet been reached, and dose escalation continues."

Clinical • First-in-human • P1 data • Castration-Resistant Prostate Cancer • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Prostate Cancer • Thrombocytopenia • Xerostomia

ProTACT: Study With [225Ac]Ac-FL-020 in mCRPC Participants (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Full-Life Technologies GmbH | Trial completion date: Dec 2026 ➔ Sep 2027 | Trial primary completion date: Jun 2026 ➔ Oct 2026

First-in-human • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

225Ac-FL-020 is a novel PSMA-targeting radionuclide drug conjugate (RDC) with superior in vivo anti-tumor activity (AACR 2024) - "Lutetium-177 (177Lu)-PSMA-617 (PLUVICTOTM) was approved in 2022 for the treatment of progressive PSMA-positive mCRPC...In addition, anti-tumor activities of 225Ac-FL-020 were evaluated in the LNCaP xenograft model and directly compared to 225Ac-PSMA-617...A mechanistic study was also conducted in 225Ac-FL-020-treated LNCaP tumor samples where DNA double-strand breaks and tumor cell apoptosis were observed, confirming the MOA of alpha emitters. Taken together, these results collectively demonstrate that 225Ac-FL-020 is a potent and selective PSMA-targeting radioligand therapy candidate with superior anti-tumor activity and a favorable safety profile warranting further clinical development."

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ProTACT: A first-in-human, phase 1 dose escalation and expansion study evaluating the safety, tolerability, and anti-tumor activity of 225Ac]Ac-FL-020, an anti-PSMA radioconjugate in patients with mCRPC. (ASCO-GU 2026) - P1 | "Secondary endpoints include overall response rate, disease control rate, radiological progression-free survival, and pharmacokinetic parameters (eg, maximum plasma concentration). The study intends to enroll patients in Australia, Turkey, the United States, and China."

Clinical • First-in-human • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer

Study With [225Ac]Ac-FL-020 in mCRPC Participants (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Full-Life Technologies GmbH | N=35 ➔ 50 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment change • First-in-human • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A First-in-human, Phase 1 Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Anti-tumor Activity of [ 225 Ac]Ac-FL-020, an Anti-PSMA Radioconjugate in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC). (EANM 2025) - No abstract available

Clinical • First-in-human • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A first-in-human, phase 1 dose escalation and expansion study evaluating the safety, tolerability, and anti-tumor activity of [225Ac]Ac-FL-020, an anti-PSMA radioconjugate, in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2025) - P1 | "Secondary objectives include assessing pharmacokinetics, dosimetry, and anti-tumor activity, with the overarching goal of exploring the potential of this novel actinium RDC for improving outcomes in patients with mCRPC. The study is enrolling in Australia and US, with European sites planned to open later in 2025."

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

Study With [225Ac]Ac-FL-020 in mCRPC Participants (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Full-Life Technologies GmbH | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2024 ➔ Oct 2024

Enrollment open • Trial initiation date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

225Ac-FL-020 is a novel PSMA-targeting radionuclide drug conjugate with promising in vivo anti-tumor activity (EANM 2024) - "Anti-tumor activity of 225Ac-FL-020 was evaluated in the LNCaP xenograft model and directly compared with 225Ac-PSMA-617. These results collectively demonstrate that 225Ac-FL-020 is a potent and selective PSMA-targeting RDC with superior anti-tumor activity and a favorable safety profile. A Phase 1 study will be started in 2024 to evaluate the safety, tolerability, and anti-tumor activity of 225Ac-FL-020 in patients with mCRPC."

Preclinical • Dental Disorders • Genito-urinary Cancer • Hematological Disorders • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Xerostomia • FOLH1

Phase 1 With [225Ac]Ac-FL-020 in mCRPC Participants (clinicaltrials.gov) - P1 | N=35 | Not yet recruiting | Sponsor: Full-Life Technologies GmbH

New P1 trial • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Full-Life Technologies Granted FDA Fast Track Designation for 225Ac-FL-020 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (PRNewswire) - "Full-Life Technologies...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for 225Ac-FL-020, the company's lead radiopharmaceutical, which targets prostate-specific membrane antigen (PSMA), for the treatment of metastatic castration-resistant prostate cancer (mCRPC)....This designation highlights the potential of 225Ac-FL-020 to provide a novel therapeutic option for patients with mCRPC, a condition for which there are currently limited effective treatments."

Fast track • Metastatic Castration-Resistant Prostate Cancer

Development of 177Lu-FL-091 for the treatment of NTSR1-positive cancers (SNMMI 2024) - "In PC-3 xenograft model that was negative for AR or PSMA expression, single dose of 177Lu-FL-091 at 37 MBq induced >30% tumor shrinkage in all treated mice (Figure E). NTSR1 was found to be highly expressed across multiple types of cancers, especially in head and neck and colorectal cancer. FL-091 displayed enhanced binding affinity to NTST1 and antagonist activity compared to 3BP-227. In addition, 177Lu-FL-091 demonstrated improved in vivo biodistribution profile vs."

Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • FOLH1

Full-Life Technologies Announces Clearance from FDA of IND Application for 225Ac-FL-020 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (PRNewswire) - "Full-Life Technologies...announced it has received clearance of its Investigational New Drug (IND) Application from the U.S. Food and Drug Administration (FDA) for clinical trials of ²²⁵Ac-FL-020, its PSMA-targeted radiopharmaceutical for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The company plans to begin clinical studies in the U.S. and globally in 2024....The upcoming Phase I clinical trial will evaluate the safety, tolerability, and anti-tumor activity of ²²⁵Ac-FL-020, and will lay the groundwork for further clinical development, aiming to establish ²²⁵Ac-FL-020 as a valuable therapeutic option for patients with mCRPC."

IND • New P1 trial • Metastatic Castration-Resistant Prostate Cancer

Full-Life Technologies Acquires Focus-X Therapeutics (WCG’s FDAnews) - "Full-Life Technologies...has entered into an agreement to acquire Focus-X Therapeutics and its cancer-targeting radiopharmaceuticals....Under the terms of the acquisition, Full-Life will gain Focus-X’s two investigational lead compounds. The first is a prostate specific membrane antigen-targeted peptide for the treatment of metastatic castration resistant prostate cancer. The second is a neurotensin receptor type 1 (NTSR1)-targeted peptide for the treatment of pancreatic cancer....Full-Life will also be acquiring Focus-X’s six other programs that are in earlier stages of development...Under the terms of the acquisition, Focus-X shareholders are eligible to receive an upfront payment along with potential development, regulatory and sales-based milestone payments of up to $245 million. The acquisition is expected to close in the first quarter of 2023."

M&A • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor