TSL1502 / Tasly - LARVOL DELTA

Randomized phase 2 trial of a PARP inhibitor TSL-1502 in germline BRCA-mutated, HER2-negative locally advanced/metastatic breast cancer. (PubMed, Signal Transduct Target Ther) - P2 | "Patients were assigned randomly (2:2:1) to receive TSL-1502 at 350 mg or 500 mg once daily or the investigator's choice of chemotherapy (eribulin, capecitabine, or vinorelbine) in 3-week cycles. No treatment-related deaths occurred. TSL-1502 at 500 mg showed promising antitumor activity and a manageable safety profile, supporting further clinical development."

Clinical • Journal • P2 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • BRCA • HER-2

A phase I clinical trial evaluating the effect of food on the pharmacokinetics of TSL-1502, a glucuronide prodrug of a novel oral poly (ADP-ribose) polymerase inhibitor, in healthy Chinese subjects. (PubMed, Front Pharmacol) - "TSL-1502 was well tolerated, and food did not affect its safety profile. These results suggest that TSL-1502 can be administered with or without food."

Journal • P1 data • PK/PD data • Hematological Disorders • Oncology • HRD

A phase I clinical trial evaluating the effect of food on the pharmacokinetics of TSL-1502, a glucuronide prodrug of a novel oral poly (ADP-ribose) polymerase inhibitor, in healthy Chinese subjects (Front Pharmacol) - "Food delayed the absorption of TSL-1502 but did not significantly affect its elimination half-life. The least-squares geometric mean ratios (fed/fasted) for AUC0-t and AUC0−∞ of TSL-1502 were 86.53% (71.23%–105.11%) and 88.36% (73.41%–106.35%), respectively. For TSL-1502M, the ratios were 90.03% (72.88%–111.22%) and 105.51% (93.51%–119.06%)."

P1 data • Oncology

A phase II study to evaluate the efficacy and safety of TSL-1502 capsules in breast cancer patients with germline BRCA mutations (ESMO 2024) - P2 | "Adult patients with HER2 negative locally advanced or metastatic breast cancer harboring germline BRCA 1/2 mutations were randomized (2:2:1) to receive TSL-1502 350mg QD, TSL-1502 500mg QD or chemotherapy by investigator's choice (eribulin, capecitabine or vinorelbine). TSL-1502 350mg and 500mg both showed preliminary anti-cancer activity in HER2 negative gBRCA 1/2 mutant breast cancer, while the higher dose showed potential better efficacy. Both dosages were well tolerated. The dose of 500mg is going to be developed for further studies."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • HER-2

A Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in Breast Cancer Patients With Germline BRCA Mutations (clinicaltrials.gov) - P2 | N=125 | Recruiting | Sponsor: Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • HER-2

A Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in Breast Cancer Patients With Germline BRCA Mutations (clinicaltrials.gov) - P2 | N=125 | Not yet recruiting | Sponsor: Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • HER-2