Étude clinique sur les performances de l'utilisation du test clinique d'essai (CTA) immunohistochimique (IHC) CTPS2 (1A3B8) dans l'étude STP938-201 : Étude ouverte de phase 1 visant à évaluer la sécurité, la tolérance et la pharmacocinétique de l'inhibiteur CTPS1 STP938 chez des sujets adultes atteints de tumeurs solides avancées, avec une extension de sécurité dans le cancer de l'ovaire avancé CTPS2 nul.

Résumé de l'essai

The clinical study will be conducted in two parts. Part 1 will explore different doses and schedules in order to establish the RP2D for adult subjects with advanced solid tumors who have failed or are ineligible for standard of care (SOC) therapy. Subjects with advanced solid tumors will be eligible for part 1 study. Part 2 will enrol adults subjects with advanced ovarian cancer lacking expression of CTPS2; subjects will have failed or be ineligible for SOC therapy.

Objectif principal

Step Pharma, is conducting a clinical study protocol, STP938-201, the main objectives of which are: 1. Evaluate the safety and tolerability of STP938 in adult subjects with advanced solid tumors. 2. Determine the recommended phase 2 dose (RP2D) and schedule for STP938 in adult subjects with advanced solid tumors 3. Evaluate the safety and tolerability of single agent STP938 at the RP2D in adult subjects with ovarian cancer, and potentially a second cancer type, whose tumors lack expression of CTPS2. The objective of this investigational device study is to test samples from ovarian cancer subjects consented for the STP938-201 clinical study. The test will be used to determine the loss of CTPS2 expression and those individuals being screened for Part 2 of the STP938-201 study will have the result considered as part of their eligibility criteria.

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