CORE-008
Multi-Cohort Study Mono/Combo
BOND-003
Phase 3 Multi-Cohort Study Monotherapy
CORE-001
Phase 2 Cretostimogene + Checkpoint Combo
CORE-008
Multi-Cohort Study Mono/Combo
CG Oncology has a robust clinical trials program with a pipeline in place to study the safety and efficacy of cretostimogene. It is purposefully designed to address the full spectrum of NMIBC disease stages and tumor types. Cretostimogene has received FDA Fast Track and Breakthrough Therapy designations.
For more information, visit cgclinicaltrials.com
1Patients with carcinoma in situ, with or without high-grade Ta/T1 disease.
2Patients with high-grade Ta/T1. Cohort P is a Phase 2 cohort of BOND-003 and currently not intended for regulatory approval.
Additionally, we’ve initiated an Expanded Access Program for cretostimogene in the US for patients with NMIBC who are unresponsive to BCG and meet certain program eligibility criteria.
A potential backbone bladder-sparing therapeutic
We remain steadfast in our mission to transform treatment across the NMIBC landscape. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
Multi-Cohort Study Mono/Combo
Phase 3 Multi-Cohort Study Monotherapy
Phase 2 Cretostimogene + Checkpoint Combo
Multi-Cohort Study Mono/Combo
How Patients can Access the on-going Studies
CG Oncology is currently focused on conducting clinical research that evaluates the safety and effectiveness of investigational cretostimogene grenadenorepvec in Non-Muscle Invasive Bladder Cancer (NMIBC). Our clinical trials program is the primary way for interested patients to access cretostimogene grenadenorepvec. We encourage patients to speak with their healthcare providers about participating in a clinical trial and may also find information on our current clinical studies site.
In circumstances where patients are not eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors, CG Oncology will consider providing a requesting physician with pre-approval access to cretostimogene grenadenorepvec, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:
Requests will be considered on a case-by-case basis. CG Oncology is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient's treating physician; CG Oncology may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration. Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to creto.eap@cgoncology.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request.