Ongoing Clinical Studies in Bladder Cancer

Cretostimogene grenadenorepvec is currently being evaluated in multiple studies including Phase 1b/2, Phase 2, and and two Phase 3 studies in the U.S. and Canada in BCG unresponsive, Intermediate-Risk and MIBC. One study is actively recruiting. Studies are on-going in South Korea, Japan, China, Taiwan, Australia, and Canada.

TRIAL TITLE

TRIAL NUMBER
STAGE
STATUS
PUBLICATION
BOND-002

Phase 2 Study in BCG-unresponsive NMIBC

Phase 2, US only

Completed
BOND-003

Phase 3 Study in BCG-unresponsive NMIBC

Phase 3, Global (US, Japan, South Korea, Taiwan, Australia, Canada)

Recruiting

CORE-001

Phase 2 Combo with Pembrolizumab

Phase 2, Global (US, South Korea)

Active, Not Recruiting
PIVOT-006

Phase 3 Study
Intermediate-Risk

Phase 3, US
and Canada

Recruiting

Phase 3 Study
Intermediate-Risk

Patients and Urologists interested in participating should contact:

JoAnn Horn
phone: 516-456-1415
joann.horn@CGOncology.com.

Expanded Patient Access

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:

  • The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option;
  • The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
  • A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
  • Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
  • Adequate supply of the investigational drug is available

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 EAP@cgoncology.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request.