Our commitment to patients
BlossomHill Therapeutics is committed to advancing innovative precision medicines for people living with cancer. We are focused on developing transformative targeted therapies designed to address the complex and evolving needs of patients, including those with limited treatment options.
Our team works closely with leading oncologists, researchers, clinical trial investigators, and advocacy organizations around the world to help accelerate the development of new therapies with the potential to improve outcomes and quality of life for patients and their families.
At BlossomHill, patients are at the center of everything we do. We are dedicated to pursuing science with urgency, purpose, and compassion in support of the cancer community.
Clinical Trials
Recruiting
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/ or HER2 Mutations (SOLARA)
SOLARA is a global, open label, Phase 1/2 clinical trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR and/or HER2 mutations. The expansion cohorts of the SOLARA trial assess single-agent BH-30643 in NSCLC patients with diverse EGFR mutations, including patients with classical and atypical EGFR mutations (whether or not they have received prior EGFR targeted therapy).
Recruiting
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Our Phase 1/1b trial evaluating BH-30236 was initiated following encouraging preclinical data, including evidence of synergistic activity between BH-30236 and venetoclax, a BCL-2 inhibitor and an established standard of care therapy for patients with AML. The trial is currently enrolling patients in dose escalation, evaluating BH-30236 as both a monotherapy and in combination with venetoclax.
Expanded Access Policy
Our mission at BlossomHill is to provide people living with cancer the opportunity to experience longer, healthier and more active lives. Our goal is to ensure the safety and efficacy of our investigational drugs and advance them through clinical trials and regulatory review to make our therapies widely available for patients who need them.
BlossomHill understands that there are some circumstances 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, BlossomHill’s 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 BlossomHill’s investigational drugs. As more clinical data on the safety and efficacy of these investigational drugs become available, BlossomHill will review and may update its policy on expanded access.
CONTACT DETAILS
If you have any questions about our investigational drugs or clinical trials, please contact clinicaltrials@bhtherapeutics.com.
TIMING OF ACKNOWLEDGMENT
- BlossomHill Therapeutics, Inc. anticipates that it will acknowledge receipt of any questions on or requests for expanded access within five business days of receipt.
- As authorized by the 21st Century Cures Act, BlossomHill Therapeutics, Inc. may revise this expanded access policy at any time. Additionally, the posting of this policy by BlossomHill shall not serve as a guarantee of access to any specific investigational drug candidate by any individual patient.
- In the United States, physicians may find additional information regarding expanded access to investigational therapies by visiting the FDA’s website, Expanded Access: Information for Physicians. Non-U.S. physicians must follow local laws and regulations appropriate for the country originating the request.
- For information on BlossomHill’s clinical trials, including eligibility criteria for participating in ongoing studies, please visit clinicaltrials.gov.