Study THE630-21-101

• Research type

  Research Study

• Full title

  A Phase 1/2 Study of the Safety, Pharmacokinetics and Anti-Tumor Activity of the Oral KIT Inhibitor THE-630 in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)

• IRAS ID

  1007313

• Contact name

  David Kerstein

• Contact email

  clinicaltrials@theseusrx.com

• Sponsor organisation

  Theseus Pharmaceuticals, Inc.

• Clinicaltrials.gov Identifier

  NCT05160168

• Research summary

  This is a first-in-human, multicenter, non-randomized, open-label Phase 1/2 study to evaluate the safety, pharmacokinetics (PK) and anti-tumor activity of oral THE-630 in patients with advanced GIST. The study will be conducted in two parts: a dose escalation phase, followed by an expansion phase. The patient population of the initial dose escalation phase (Phase 1) of the trial will include patients with unresectable or metastatic GIST. Patients must have disease progression on or be intolerant to imatinib therapy and have also received at least 1 of the following: sunitinib, regorafenib, ripretinib, or avapritinib. The dose escalation phase of this trial will employ sequential dose escalation of THE-630 using a standard 3+3 design. Once a recommended dose has been determined in the escalation phase, the expansion phase (Phase 2) will enroll 3 cohorts of patients with unresectable or metastatic GIST defined by prior therapy.
  Approximately 90-160 patients will be enrolled in the study, assuming the following: in Phase 1, approximately 30-100 patients will be enrolled. In Phase 2, approximately 20 patients will be enrolled in each of three cohorts.
  The trial is divided into:
  Screening period: 2-3 weeks
  • Treatment period: at least 1 cycle (28 days)
  • Follow-up period after last dose of study drug: 30 days
  Thereafter, patients are to be followed for subsequent antineoplastic therapy and survival approximately every 3 months until death, withdrawal of consent or closure of the study by the Sponsor.
  Participation is voluntary.
  Participants will be expected to attend clinic visits for safety and efficacy assessments in this study

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  23/LO/0338

• Date of REC Opinion

  6 Jun 2023

• REC opinion

  Further Information Favourable Opinion