NUVATION BIO POLICY ON EXPANDED ACCESS
Nuvation Bio understands that there are some cases when a patient is unable to participate in a clinical trial and other treatment options have been exhausted. In those cases, the patient’s physician may choose to request access to an investigational drug outside of a clinical trial through an Expanded Access pathway. Expanded access refers to a pathway in which patients with serious or immediately life-threatening diseases may gain access to an investigational drug outside the context of participation in clinical trials designed to evaluate safety and efficacy.
At this time, Nuvation Bio products are considered investigational, which means that they have not been approved as safe and effective by regulatory health authorities, such as the United States Food and Drug Administration (FDA). Currently, participation in clinical trials is the only way for patients to gain access to Nuvation Bio’s investigational drugs. As more clinical data on the safety and efficacy of these investigational drugs become available, Nuvation Bio will review and update its policy on Expanded Access. For information on Nuvation Bio’s clinical trials, please email NuvationBio@elligodirect.com.
NUVATION BIO CURRENT CLINICAL TRIALS
Before a new treatment can be made available to the public, clinical trials must be conducted to evaluate the safety and effectiveness of an investigational drug.
Nuvation Bio is conducting clinical trials in multiple oncology indications. Learn more about these ongoing studies by visiting ClinicalTrials.gov.
Phase 1/2 Study of NUV-868 as a monotherapy and in combination with olaparib or enzalutamide in multiple tumor types (NUV-868-01)
We are currently enrolling a Phase 1 monotherapy, dose escalation study in patients with advanced solid tumors. We are also enrolling a Phase 1b dose escalation study of NUV-868 in combination with olaparib for the treatment of patients with ovarian, pancreatic, metastatic castration-resistant prostate, triple negative breast cancers and other solid tumors, and of NUV-868 in combination with enzalutamide for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1b study will be followed by a Phase 2b study to further explore safety and efficacy once the recommended Phase 2 combination dose is determined. We also plan to initiate a Phase 2 monotherapy study in patients with mCRPC to further explore the safety and efficacy of NUV-868. Learn more about this clinical trial here.
ClinicalTrials.gov Identifier: NCT05252390