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Spots Global Cancer Trial Database for A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)

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Trial Identification

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

Conditions

Metastasis

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Sciences & Operations

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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