Clinical Trials
Striving for the next leap forward in patient outcomes and quality of life.
OVERVIEW OF CLINICAL TRIALS
Status:
Enrolling
BH-30643-01: A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Subjects with Locally Advanced or Metastatic NSCLC Harboring EGFR And/or HER2 Mutations (SOLARA)
BlossomHill is enrolling a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations.
Learn more about our clinical trial (NCT06706076) at clinicaltrials.gov.
Status:
Enrolling
Status:
Enrolling
BH-30236-01: Phase 1 Clinical Trial for a Multi-targeted CLK Inhibitor in Relapsed or Refractory Adult Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndrome (HR-MDS)
BlossomHill is enrolling a first-in-human, open-label, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics and preliminary efficacy of BH-30236 for patients with relapsed or refractory AML or HR-MDS.
Learn more about our clinical trial (NCT06501196) at clinicaltrials.gov.
Status:
Enrolling
Considering Participation in a Clinical Trial?
If you’re looking for an opportunity to access new cancer treatments, these trials can offer therapies that aren’t yet available to the general public. These trials are examining treatment options that may more effective than those currently available. By participating in a clinical trial, you become a vital part of advancing medical research, contributing to knowledge that could help countless others in the future.
Access to Investigational Drugs Outside a Clinical Study
Policy on Expanded Access
Our mission at BlossomHill is to provide people living with cancer or autoimmune diseases 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.