A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)
Stopped early · Phase 1/Phase 2
Conditions studied: Metastasis
In brief
Primary 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).
Key facts
- Study ID
- NCT04009681
- Run by
- Synthorx, Inc, a Sanofi company
- People needed
- 175
- Starts
- 2019-06-20
- Expected to finish
- 2025-12-02
- Last updated by the study team
- 2025-12-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Investigational Site Number-1008 — Scottsdale, Arizona, United States
- Investigational Site Number-1005 — Denver, Colorado, United States
- Investigational Site Number-1004 — Sarasota, Florida, United States
- Investigational Site Number-1003 — Nashville, Tennessee, United States
- Investigational Site Number-1007 — Dallas, Texas, United States
- Investigational Site Number-1002 — Houston, Texas, United States
- Investigational Site Number-1001 — San Antonio, Texas, United States
- Investigational Site Number-7002 — Buenos Aires, Argentina
- Investigational Site Number-2004 — New South Whales, Australia
- Investigational Site Number-2001 — Perth, Australia
- Investigational Site Number-2002 — Victoria, Australia
- Investigational Site Number-2003 — Victoria, Australia
- Investigational Site Number- 6001 — Santiago, Chile
- Investigational Site Number-6002 — Santiago, Chile
- Investigational Site Number-4002 — Singapore, Singapore
- Investigational Site-4001 — Singapore, Singapore
- Investigational Site Number-5001 — Barcelona, Spain
- Investigational Site Number-5006 — Barcelona, Spain
- Investigational Site Number-5007 — Barcelona, Spain
- Investigational Site Number-5002 — Madrid, Spain
- Investigational Site Number-5003 — Madrid, Spain
- Investigational Site Number-5004 — Madrid, Spain
- Investigational Site Number-5005 — Madrid, Spain
- Investigational Site Number-5105 — Madrid, Spain
Full record on ClinicalTrials.gov
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