Drugs / 177Lu-DOTA-TLX591
177Lu-DOTA-TLX591
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT04786847 | Jan 2022 → Sep 2023 | metastatic prostate carcinoma | Telix Pharmaceuticals (Innovations) Pty Limited | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT05146973 | Aug 2022 → Jul 2023 | prostate cancer | Telix Pharmaceuticals (Innovations) Pty Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Telix Pharmaceuticals (Innovations) Pty Limited | Results TLX591-Tx ProstACT SELECT Study Published in Cancers Journal telixpharma.com ↗
The publication highlights TLX591-Tx’s differentiated clinical profile, including an intensified dosing schedule, prolonged tumor retention and low exocrine (salivary) gland irradiation. |
| 2026-07-02 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Alignment to Advance ProstACT Global Phase 3 Trial telixpharma.com ↗
FDA and Telix align on advancement into Part 2 of the ProstACT Global Phase 3 study in the United States. |
| 2026-06-02 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ProstACT Global Phase 3 (Part 1) Data Presented in Late-Breaking Oral Session at ASCO 2026 telixpharma.com ↗
Results demonstrated that TLX591-Tx, Telix’s lead prostate-specific membrane antigen (PSMA) targeted lutetium rADC therapy candidate, has a acceptable safety and tolerability profile when administered with standard of care (SoC) therapies in mCRPC, with no new safety signals observed. |
| 2026-03-10 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives telixpharma.com ↗
Telix today announces that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed. |
| 2025-07-22 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新RDC药物TLX591加入国际多中心III期临床试验的申请已获国家药监局默示许可 grandpharm.com ↗
远大医药(0512.HK)用于治疗前列腺癌的全球创新在研放射性核素偶联药物(RDC) TLX591 ( 177 Lu-rosopatamab tetraxetan)加入国际多中心III期临床试验的申请，近日已获得国家药监局默示许可，这是远大医药在核药抗肿瘤诊疗领域的重要研发进展。 |
| 2025-05-07 | GrandPharma (China) Co., Ltd. | Regulatory 再传捷报！远大医药全球创新RDC产品TLX591加入国际多中心III期临床试验的申请已获国家药监局受理 grandpharm.com ↗ |
| 2024-06-05 | GrandPharma (China) Co., Ltd. | Results 远大医药全球创新放射性核素偶联药物TLX591及TLX250-CDx取得临床进展 grandpharm.com ↗
TLX591用于治疗前列腺癌的海外III期临床研究呈现积极数据，其放射学无进展生存期(rPFS)中位数为8.8个月； |
| 2024-05-30 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Telix Announces Positive rPFS Data from ProstACT SELECT Trial of TLX591 rADC Therapy Candidate in Prostate Cancer telixpharma.com ↗
The study has reported a median rPFS of 8.8 months, representing an encouraging signal of the potential efficacy of TLX591 in this patient population. |
| 2023-10-18 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ProstACT SELECT Study of TLX591 Interim Readout: Positive Results Confirm Safety and Tolerability telixpharma.com ↗
Telix today announces positive preliminary results from the Phase I ProstACT SELECT study of its rADC therapy candidate TLX591 (Lutetium (177Lu) rosopatamab tetraxetan) for prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC). |
| 2022-06-10 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新放射性核素偶联药物再迎新突破 TLX591-CDx在日本完成首例患者给药 TLX591在澳洲获批III期临床研究 grandpharm.com ↗
而用于前列腺癌治疗的放射性核素偶联药物TLX591 (177Lu-DOTA-Rosopatamab) (“TLX591”)，获批开展III期临床研究并获得了人类研究伦理委员会(Human Research EthicsCommittee)的伦理批准。 |
| 2021-05-11 | GrandPharma (China) Co., Ltd. | Regulatory FIC：抗体偶联放射性药物TLX591获批III期临床，远大医药享有中国权益 grandpharm.com ↗
5月9日，澳大利亚创新药公司Telix宣布，旗下抗体偶联放射性药物TLX591获澳大利亚药物管理局批准开展III期临床试验，用于治疗转移性去势抵抗性前列腺癌（mCRPC），远大医药享有中国权益。 |
| 2021-05-10 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Commences Phase III Clinical Trial of Prostate Cancer Therapy telixpharma.com ↗
Telix has been granted HREC approval and received CTN clearance by the TGA to commence a Phase III study of the Company’s prostate cancer therapy candidate TLX591, in patients with advanced prostate cancer. |
| 2020-07-08 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Receives FDA Feedback on Phase 3 Trial Design for Prostate Cancer Therapy Product telixpharma.com ↗
Telix Pharmaceuticals Limited announces that the FDA has provided feedback that will enable the Company to finalize the Phase 3 PROSTACT trial |
| 2020-05-14 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Pharmaceuticals Granted July Pre-IND Meeting with US FDA for Phase III ProstACT Study telixpharma.com ↗ |
| 2019-12-27 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory NDA Clinical Briefing Package Submitted to the US FDA telixpharma.com ↗
Telix Pharmaceuticals announces that it has submitted a complete clinical briefing package to the US FDA for its first product TLX591-CDx1 |
All press releases naming this drug 27 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 177Lu-DOTA-TLX591 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05146973 ↗ |
| Known as | 177Lu-TLX591 | “TLX591, a monoclonal antibody HuX591 conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-TLX591)” NCT04786847 ↗ |
| Known as | TLX591 | “This is a Phase 1 trial of TLX591, a monoclonal antibody HuX591 conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591).” NCT04786847 ↗1“TLX591, a monoclonal antibody conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591)” NCT05146973 ↗ |
| Modality | Monoclonal antibody | “TLX591, a monoclonal antibody HuX591 conjugated with a DOTA chelator and radiolabelled with 177Lu” NCT04786847 ↗ |
| Route | Intravenous | “two single intravenous (IV) infusions of 76 mCi each” NCT04786847 ↗ |