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THOR-707 · HAMMER
A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)
Ensayo de Sanofi en Metastasis (del registro, en inglés).
- Fase
- Fase 1/2
- Estado
- Interrumpido
- Participantes
- 175
- Centros
- 24
- Fin del objetivo primario
- dic 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en jun 2019.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study was terminated as per Sponsor decision. The decision was not related to any safety concerns.».
Qué mide
Rate of Dose-Limiting Toxicities (DLTs)- Cohorts A, B, C, and D (Study Day 1 up to Day 29) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objectives: * Evaluate the safety and tolerability of THOR-707 as a single agent and as a combination therapy (identify Dose Limiting Toxcitiy (DLTs) in Cohorts A, B, C, D, and G, and adverse events (AEs)/serious adverse event (SAE) profile in Cohorts A, B, C, D, E, F, and G) * Define the Maximium Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of THOR-707 as a single agent and as a combination therapy (Cohorts A, B, C, D, and G) * Evaluate preliminary anti-tumor activity of THOR-707 as a single agent by determination of the objective response rate (ORR) defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohort H only) Secondary Objectives: * Evaluate preliminary anti-tumor activity of THOR-707 as a single agent and as a combination therapy by determination of the objective response rate (ORR) defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohorts A, B, C, D, E, F, and G) * Determine time to response (TTR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and clinical benefit rate (CBR) of THOR-707 as a single agent and as a combination therapy * Evaluate the safety and tolerability of THOR-707 monotherapy QW/Q2W (AE/serious adverse event \[SAE\] profile) (Cohort H only).
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Ficha completa en ClinicalTrials.gov (NCT04009681), actualizada en dic 2025.