The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)
Official Title: An Open-Label, Multicenter Phase 1/2 Dose Escalation and Expansion Study of THOR-707 as a Single Agent and as a Combination Therapy in Adult Subjects With Advanced or Metastatic Solid Tumors
Study ID: NCT04009681
Brief Summary: 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), and disease control rate (DCR) 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).
Detailed Description: The study duration per participant is approximately 24 months (inclusive of follow-up). Cohorts A, B, C, and D have been completed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR