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Fulvestrant, Bbi-940
Advanced Breast Cancer, Breast Cancer, Metastatic Breast Cancer
Phase I
Not Yet Recruiting
Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
Jan 22, 2026
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Erlotinib, Bbi-825, Bbi-355, Futibatinib
Small Cell Lung Cancer, Pancreatic Cancer Metastatic, Triple Negative Breast Cancer (Tnbc), Er+ Breast Cancer, Cervical Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma (Cscc), High Grade Serous Ovarian Carcinoma, High Grade Endometrial Carcinoma, Anogenital Cancer, Head And Neck (Hnscc), Leiomyosarcoma (Lms), Undifferentiated Pleomorphic Sarcoma (Ups)
Phase I
Active Not Recruiting
Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications
Mar 27, 2023
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Boundless Bio Inc. (BOLD) have in its pipeline
BOLD is currently developing the following drugs: Fulvestrant, Bbi-940, Bbi-825, Erlotinib, Bbi-825, Bbi-355, Futibatinib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.