STC-15

STC-15 in Combination With Toripalimab in Selected Advanced Cancers and as Monotherapy in Selected Sarcomas

Agent: STC-15 (a METTL3 inhibitor)
Phase Ib/II
Status Recruiting
Sponsor STORM Therapeutics LTD

 

For further information please also consult https://clinicaltrials.gov/study/NCT06975293

This is an open-label, non-randomized, multi-cohort, Phase 1b/2 trial investigating the safety, tolerability, and antitumor activity of STC-15 (a METTL3 inhibitor) in combination with toripalimab in participants with selected advanced cancers, and as monotherapy in participants with selected sarcomas.

 

WHO is the trial for?

This study is for people with advanced sarcomas that cannot be removed with surgery or that have spread to other parts of the body (metastatic disease). The study is focusing on certain sarcoma subtypes that have come back or continued to grow after treatment, including:

  • dedifferentiated liposarcoma (DD liposarcoma)
  • leiomyosarcoma (both uterine and non-uterine)

Key Inclusion Criteria

Participants must:

  • be reasonably active and able to care for themselves (ECOG performance status 0–1)
  • have measurable tumors (according to RECIST v1.1)
  • have evidence that the cancer has progressed after previous treatment
  • have adequate organ function (such as liver, kidney, and bone marrow function)
  • be able to swallow and absorb oral medication

Additional requirements for the Phase 2 monotherapy part of the study

Participants must:

  • have a confirmed diagnosis of one of the selected sarcoma subtypes
  • have disease that cannot be cured with local treatment such as surgery or radiation
  • have received at least 2, but no more than 4, previous systemic treatments

Additional medical criteria also apply and will be reviewed by the study team.

WHAT is the key question that this trial is attempting to answer?

 This early-phase study aims to determine:

  • Is the treatment safe and tolerable?
  • What is the best dose of the therapy?
  • Are there early signs that the treatment may help shrink tumors?

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is currently being conducted in the US. For further information check here.

Study Contact
Name: Sandra Tong, MD
Phone Number: 650-399-6357
Email: sandy.tong@stormtherapeutics.com

Study Contact Backup
Name: Melinda Snyder
Phone Number: 617-233-4057
Email: melinda.snyder@stormtherapeutics.com

STUDY DESIGN: What does the study look like?

 This is a Phase Ib/II open-label study. All participants receive the investigational treatment. There is no placebo group.

The study has three parts:

  • Part A – Phase I dose escalation: STC-15 in combination with toripalimab in 21-day cycles.
    Small groups of patients receive increasing doses to determine the safest dose.
  • Part B – Phase II Stage 1 Monotherapy: STC-15 monotherapy in 21-day cycles
  • Part C – Phase II Stage 2 Monotherapy: STC-15 monotherapy in 21-day cycles

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken