FOR PATIENTS
Nuvation Bio is focused on treating patients with the most difficult-to-treat cancers for which conventional therapies have failed.
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.
Trial Title
Trial Number
Stage
Status
Trial Title
Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC (TRUST-II)
Trial Number
Stage
Phase 2, Global (US, Japan, Korea, Europe, Canada, and China)
Status
Recruiting
Trial Title
A Study of taletrectinib in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene (TRUST-I)
Trial Number
Stage
Phase 2, China
Status
Active, Not Recruiting
Trial Title
Safusidenib Phase 2 Study in IDH1 Mutant Glioma
Trial Number
Stage
Phase 2, Global (currently recruiting in US, global expansion planned)
Status
Recruiting
Trial Title
IDH1 Inhibitor AB-218 in Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumor
Trial Number
Stage
Phase 1, China
Stage
Recruiting
Trial Title
Phase 1/2 Study of NUV-868 as a monotherapy and in combination with olaparib or enzalutamide in multiple tumor types (NUV-868-01)
Trial Number
Stage
Phase 1/2, US
Status
Recruiting
Trial Title
Phase 1/2 Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors
Trial Number
Stage
Phase 1/2, US
Status
Recruiting
Nuvation Bio Global Early Access Policy
Nuvation Bio is a global biopharmaceutical company focused on treating patients with difficult-to-treat cancers for which conventional therapies have failed.
To realize our mission, we must conduct the research and clinical trials necessary to evaluate the safety and effectiveness of our investigational medicines. We believe that rigorous clinical trials are the most appropriate way to do this. If successful, data from these studies may be used to seek potential approval from regulatory authorities (such as the U.S. FDA and China NMPA) – with the ultimate goal of making our medicines available to as many eligible patients as safely and quickly as possible.
More information about Nuvation Bio’s ongoing clinical trials can be found by visiting here.
We recognize that, in some cases, patients with serious or life-threating diseases may not be eligible for or are unable to participate in clinical trials and may have exhausted all other treatment options. If a patient is not eligible or unable to participate in a clinical trial, they may be able to access an investigational medicine via an early access program, if available.
General Criteria
When considering offering early access to our investigational therapies, Nuvation Bio undertakes careful consideration of many factors, including: the safety and effectiveness of our therapies as they continue to be evaluated in clinical trials; and our manufacturing capabilities and drug supply capacity. Additional criteria we consider include:
- The Nuvation Bio investigational therapy must be in active development in clinical trials.
- The disease must be serious or life-threatening and the person must not be eligible for or unable to participate in any ongoing clinical trials or other approved therapies.
- There is sufficient clinical evidence that suggests the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information of the investigational therapy being developed by Nuvation Bio.
- There is sufficient evidence to identify an appropriate dose for early access use.
- Granting early access would be unlikely to compromise, interfere with or delay the development programs, ongoing clinical trials, or regulatory filings designed to make the therapy available to many more patients.
- Early access to Nuvation Bio investigational medicines must comply with relevant country-specific ethical guidelines and regulations.
How to Request Access
We believe the most appropriate way to access our investigational medicines is to participate in clinical trials regulated by the FDA and other global regulatory authorities.
However, if you would still like to seek access to a Nuvation Bio investigational medicine, please follow these steps:
- Review the criteria for consideration of access listed above.
- Ask the patient’s qualified treating doctor to make a formal request to Nuvation Bio at earlyaccess@nuvationbio.com.
How Decisions are Made
Nuvation Bio is committed to a fair and impartial evaluation of each request for access to our medicines. All decisions are based on clinical circumstances and are guided by the principles outlined above.
Whenever possible, patients will be referred to ongoing clinical trials as the primary way to access our investigational medicines.
Decisions regarding potential early access or compassionate use of investigational or unapproved medicines can only be made, in certain circumstances, after in-depth discussions between Nuvation Bio clinical teams and the patient’s qualified treating doctor acting on their behalf.
If you have additional questions, please speak with your doctor, or have your doctor contact earlyaccess@nuvationbio.com. We anticipate acknowledging receipt of requests sent to this email within five business days.
In line with the 21st Century Cures Act, Nuvation Bio, may revise this policy at any time.
