A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101) — HAMMER  

Metastasis Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

The study duration per participant is approximately 24 months (inclusive of follow-up). Cohorts A, B, C, and D have been completed. ;

Related Conditions & MeSH terms

• Metastasis
• Neoplasm Metastasis

• NCT number: NCT04009681
• Study type: Interventional
• Source: Synthorx, Inc, a Sanofi company
• Contact: Trial Transparency email recommended Toll Free Number for US and
• Phone: 800-633-1610
• Email: Contact-US@sanofi.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 20, 2019
• Completion date: June 2026