Expanded Access Program for Cretostimogene Grenadenorepvec in Treating Bladder Cancer Unresponsive to BCG

Sponsor: CG Oncology, Inc.

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06443944

Provider View

This program offers access to a treatment called cretostimogene for patients with non-muscle invasive bladder cancer (NMIBC) that hasn't responded to BCG therapy.

Patient Parameters

Program Overview

This trial is designed to provide patients with NMIBC, who haven't responded to BCG treatment, access to a new therapy called cretostimogene. The study aims to see if this treatment can help manage their cancer.

Description

Participants in this program will follow a set treatment schedule. Initially, they will receive an induction course of the treatment. If there is no sign of cancer returning by Week 13, they will continue with a cycle of three weekly treatments up to Week 15.

If the cancer is still present at Week 13, participants may receive another induction course. If the cancer is not detected after this, they will receive three weekly treatment cycles every 12 weeks until Month 12.

After the first year, participants will receive treatment cycles every six months until the final cycle at Month 24, or until they stop the study treatment.

The status of the cancer will be checked using urine tests, bladder examinations, and biopsies if needed, every 12 weeks, and imaging tests every 24 weeks, for up to two years.

Eligibility Criteria

Inclusion Criteria

  • Have bladder cancer that hasn't responded to BCG treatment, confirmed by tests.
  • No limit on previous BCG treatments, but they should follow standard schedules.
  • Cancer must have returned or persisted within 12 months after the last BCG treatment.
  • Completed a specific amount of BCG treatment within 12 months of starting the study.
  • Cancer confirmation within 16 weeks before joining the study.
  • Cancer must be mostly urothelial cells with less than 50% other types.
  • All visible cancer must be removed before starting the study treatment.
  • Not eligible for bladder removal surgery or have refused it.
  • Must have acceptable organ function at the start of the study.

Exclusion Criteria

  • Have muscle-invasive, advanced, or metastatic bladder cancer.
  • Have active autoimmune or inflammatory disease needing treatment within 4 weeks before starting the study.
  • Have received any cancer treatment, including experimental drugs, within 4 weeks before starting the study.
  • Are pregnant, breastfeeding, or planning to breastfeed from the start of the study until 6 weeks after the last treatment.

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