An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG

Bladder Cancer Clinical Trial

Official title:

An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT06443944
• Other study ID #: CRETO-EAP
• Status: Available

Study information

• Verified date: May 2024
• Source: CG Oncology, Inc.
• Contact: Andy Darilek, MD
• Phone: 949-419-6149
• Email: recruitment[@]cgoncology.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC unresponsive to BCG.

Description:

All participants will be assigned the same treatment schedule. Participants will receive an induction course and, if there is no disease recurrence at Week 13, participants will receive a cycle of 3 weekly treatments up to Week 15.

If there is persistent HG Ta and/or CIS at Week 13, participants may receive a second induction course.

If there is no disease present thereafter, participants will receive 3 weekly treatment cycles every 12 weeks through Month 12.

After Month 12, participants will receive 3 weekly treatment cycles every 6 months through the last treatment cycle at Month 24, or until discontinuation from the study treatment.

Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 12 weeks and CTU/MRU every 24 weeks, for up to 2 years.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive CIS will also require the following:

1. Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease) within 12 months of last dose of adequate BCG treatment for HGUC.

2. Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG.

3. Pathological confirmation of BCG unresponsive CIS within 16 weeks of study enrollment.

4. CIS specimen must be predominantly urothelial (transitional cell) and have less than 50% variant histology.

5. No maximum limit to the amount of BCG administered; however, there should be no more than 12 months between cycles of BCG.

• Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment NOTE: T1 disease resection site must have biopsy evaluation of the prior resection site 2-12 weeks prior to initial study treatment.

• Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.

• Acceptable baseline organ function

Exclusion Criteria:

• Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.

• Has had active autoimmune or inflammatory disease requiring systemic treatment within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of systemic treatment and is allowed.

• Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1

• Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 6 weeks after the last study treatment.

Related Conditions & MeSH terms

• Bladder Cancer
• Non-Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms
• Urologic Cancer
• Urologic Neoplasms
• Urothelial Carcinoma

Intervention

Drug:
• Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus

Other:
• n-dodecyl-B-D-maltoside
Transduction-enhancing agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CG Oncology, Inc.

References & Publications (2)

Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16. — View Citation

Holzbeierlein JM, Bixler BR, Buckley DI, Chang SS, Holmes R, James AC, Kirkby E, McKiernan JM, Schuckman AK. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment. J Urol. 2024 Apr;211(4):533-538. doi: 10.1097/JU.0000000000003846. Epub 2024 Jan 24. — View Citation

External Links

•   NCCN Guidelines Bladder Cancer 3.2023
•   NCCN Guidelines Bladder Cancer 4.2024