Expanded Access Program for STC-15 in Patients with Advanced Cancer

Sponsor: STORM Therapeutics LTD

Expanded Access
Sponsor score: 0

ClinicalTrials ID:NCT07906093

Provider View

This program provides access to the experimental drug STC-15 for patients with serious cancers who have no other treatment options and cannot join a clinical trial. It is available for both adults and children under specific conditions.

Patient Parameters

Program Overview

This Expanded Access Program allows patients with serious or life-threatening cancers to receive the drug STC-15 outside of a clinical trial. It is intended for those who might benefit from STC-15, have no other treatment options, and cannot join an ongoing clinical trial for STC-15 in a timely manner. The program is open to adults and, under certain conditions, children. Patients must meet specific eligibility criteria to participate.

Description

STC-15 is taken by mouth three times a week in 21-day cycles. Patients will have regular medical check-ups and safety monitoring as part of the program. These assessments will follow the program's guidelines and the usual practices at the treatment center, with additional checks if needed by the doctor.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older, or children aged 2 or older with approval, who have a serious cancer.
  • Cancer must be confirmed by lab tests and be advanced, cannot be removed by surgery, has spread, or has returned after treatment.
  • No other approved treatments are available, or the patient cannot tolerate them, or they have not worked.
  • Cannot join a clinical trial for STC-15 in a reasonable time.
  • May combine STC-15 with other treatments if approved.
  • Must have active cancer confirmed by recent tests.
  • Must be able to take oral medication or have a plan for taking it another way.
  • Must have recovered from previous treatments and not be taking conflicting medications.
  • Women must use effective birth control during and after treatment; men must use condoms and not donate sperm during and after treatment.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Uncontrolled infections or serious illnesses that increase risk.
  • Unstable heart or lung conditions, or uncontrolled seizures.
  • Active brain cancer that is not stable or treated.
  • Recent major surgery or radiation that has not healed.
  • Cannot take medications that interfere with STC-15.
  • Any condition that makes treatment unsafe or prevents proper monitoring.

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