Talidox (doxorubicin liposomal) / Innomedica - LARVOL DELTA

TLD-1, a Second-Generation Nano-Liposomal Doxorubicin, in Patients with Advanced Breast Cancer from the Dose Escalation and Expansion Phase 1 Study (SAKK 65/16) (SG-BCC 2025) - "The study included two phases: dose escalation, where dose levels were incrementally increased, and a pharmacokinetic (PK) crossover amendment, comparing TLD-1 at RP2D with Caelyx 40mg/m2 in treatment Arms A and B. Study objectives included tumor response, dose-limiting toxicities (DLTs), and treatment-related adverse events (TRAEs). TLD-1, administered at the RP2D of 40 mg/m² every three weeks, demonstrated anti-tumor activity and favourable safety profile in advanced breast cancer patients who had undergone multiple prior treatments. This study establishes a strong foundation for the future development of TLD-1 as a treatment option for patients with advanced breast cancer"

Clinical • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor

SAKK 65/16: TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Terminated | Sponsor: Swiss Group for Clinical Cancer Research | N=30 ➔ 12 | Trial completion date: Oct 2024 ➔ Dec 2023 | Recruiting ➔ Terminated; The premature termination is based on the unexpectedly low patient accrual to the clinical trial and the strategic considerations in the development of the TLD-1 after having included 13 out of 14 patients in the comparative PK part.

Enrollment change • Metastases • Trial completion date • Trial termination • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

Population pharmacokinetics of TLD-1, a novel liposomal doxorubicin, in a phase I trial. (PubMed, Cancer Chemother Pharmacol) - P1 | "The population PK of TLD-1, including its release and main metabolite, were successfully characterised using non-compartmental and compartmental analyses. Based on its long half-life, TLD-1 presents a promising candidate for further clinical development. The PK characteristics form the basis to investigate TLD-1 exposure-response (i.e., clinical efficacy) and exposure-toxicity relationships in the future. Once such relationships have been established, the developed population PK model can be further used in model-informed precision dosing strategies."

Journal • P1 data • PK/PD data • Oncology • Solid Tumor

Understanding the In Vitro-In Vivo Nexus: Advanced Correlation Models Predict Clinical Performance of Liposomal Doxorubicin. (PubMed, Int J Pharm) - "Anchored in our aim to elucidate this in vitro-in vivo nexus, we compared TLD-1, a novel liposomal doxorubicin delivery system, against the established formulations Doxil® and Lipodox®. Data from a Phase-I clinical trial facilitated the development of patient-specific IVIVCs using the physiologically-based nanocarrier biopharmaceutics model, enabling a more accurate estimation of doxorubicin exposure. This advancement could impact clinical practice by allowing for more precise dose estimation and aiding in the assessment of the interchangeability of generic liposomal doxorubicin."

Journal • Metastases • Preclinical

TLD-1, a novel liposomal doxorubicin, in patients with advanced solid tumors: Dose escalation and expansion part of a multicenter open-label phase I trial (SAKK 65/16). (PubMed, Eur J Cancer) - P1 | "The new liposomal doxorubicin formulation TLD-1 showed a favourable safety profile and antitumor activity, particularly in breast cancer. RP2D was defined at 40 mg/m2 administered every 3 weeks. (NCT03387917)."

Journal • Metastases • P1 data • Breast Cancer • Dermatology • Fatigue • Mucositis • Oncology • Solid Tumor • Stomatitis

TLD-1, a novel liposomal doxorubicin, in patients with advanced solid tumors: dose escalation and expansion part of a multicenter open-label phase I trial (SAKK 65/16) (Eur J Cancer) - P1 | N=30 | NCT03387917 | "30 patients were enrolled between November 2018 and May 2021. No dose-limiting toxicities (DLT) were observed. Maximum administered dose of TLD-1 was 45 mg/m2, RP2D was defined at 40 mg/m2....Overall objective response rate was 10% in the whole population and 23.1% among 13 patients with breast cancer; median time-to-treatment failure was 2.7 months. TLD-1 exhibit linear pharmacokinetics, with a median terminal half-life of 95 hours."

P1 data • Solid Tumor

SAKK 65/16: TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Swiss Group for Clinical Cancer Research

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

An Oncologist From Guam Devotes His Career to the Care of Pelvic Cancers and the Sexual Health of All Cancer Survivors (THE ASCO POST) - "'Dr. Krychman and I would chat about people we both had seen. And we ended up writing a case report about the toxicities of liposomal doxorubicin on the female genital area. It was a first report of its kind."

Online posting

SAKK 65/16: TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Swiss Group for Clinical Cancer Research | Active, not recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

Capstone Announces FDA Approval and EU Authorization of Doxorubicin Hydrochloride Liposome Injection (PRNewswire) - "Capstone Development Services...announced today that it has received approval from the U.S. Food and Drug Administration (FDA), as well as authorization from the European Commission for doxorubicin hydrocholoride liposomal injection. Authorized as a treatment for multiple types of cancer, the product was developed by Capstone in partnership with a leading medical products company....The authorizations mark the 19th and 20thth regulatory approvals Capstone has gained for products developed since its founding in 2013. Capstone funded, developed and led the regulatory approval process of the product. After gaining approvals, it transferred ownership of the product to its medical products partner."

ANDA • European regulatory • Breast Cancer • Multiple Myeloma • Oncology • Ovarian Cancer • Sarcoma

SAKK 65/16: TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Swiss Group for Clinical Cancer Research | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor